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Please refer to the new eIFU Website of optimed:

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Dear patient,

You have received an implant from optimed. Please read this patient information carefully since it contains important information about the implant.

Your doctor has given you an International Implant Card. First of all, we would like to explain the symbols used on this card to you:

List of symbols recommended for use on the International Implant Card:

Patient Name or Patient ID

Date of implantation

Name and Address of the implanting healthcare institution/ provider

Device Name (The doctor has to peel the identification label from the product and place it to the corresponding field on the PIC.)

Magnetic resonance

Information website for patients

Name and Address of the manufacturer

Regular Follow-Up Visits

It’s important to go to all follow-up appointments with your healthcare team, even if you’re feeling well. During these visits, your doctor will monitor your progress, evaluate your medications, check the status of your disease and determine how the stent is working for you.

Stent Implant Card

Whether you’re running a quick errand or going on vacation, it’s important to carry your stent implant card with you at all times. If you receive dental or medical care or report to an emergency room, show your stent implant card. You will be given an implant card at the time of your procedure. Your implant card contains your name, your doctor’s name and phone number, and information about your implanted stent(s).

The implant may have an impact on medical investigations, especially on magnetic resonance imaging (MRI). Your stent is one of the items that may create a health hazard or other problem during an MRI examination. Therefore, you need to present your implant card to the MRI technologist or radiologist, that he can find, via the QR code or web address, this website. In some unusual cases the examination may be cancelled because of concern related to a particular implant or device.

Below we have summarized for each stent some information regarding MRI Compatibility, Possible Complications, Intended Use and some additional important information.

If you have questions or need further information on the optimed stents, please contact our Customer Service department in Germany by phone toll-free at 0800-7628000 (for calls within Germany) or send an email to info@optimed.com. For calls from abroad, you can reach us by phone at +49 7243 7633-0.

Please choose from the list below the stent implanted into your body. You can find the name of your stent on the label on the inside of the implant card.

We wish you good health!

Your optimed team

Venous Stents:

Arterial Stents:

Urology:

Information on MR compatibility related to optimed stents

Venous Stents:

sinus-Obliquus

MR Compatibility:

The implant / device was determined to be MRI-conditional according to the guidelines of the American Society for Testing Materials (ASTM) International, Designation: F2503-13: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic

Resonance Environment.

MRI-Related Displacement Force and Torque

A scientific investigation [1, 2] demonstrated that implants / devices made out of nitinol and / or tantalum are MRI-conditional. A patient with this implant / device can be scanned safely immediately after placement under the following conditions:

Static magnetic field of 3.0 Tesla or less

MRI-Related Heating

In non-clinical testing, the implant / device produced the following temperature rises when MRI was performed for 13 min at 1.5 Tesla (MIPS 1.5, Medical Implant Test System, Software MIPS-DUALBAND 1.2.5.2) and 3 Tesla (Signa Hdxt, General Electric (GE) Medical Systems, Software 15.0_M4_0910.a) MRI-systems and at an average whole-body SAR of 2.5 W / kg registered by the MRI system.

Highest temperature change MRI-condition:

Less than or equal to 4.0 degrees C at 1.5 Tesla
Less than or equal to 4.0 degrees C at 3.0 Tesla

Remark: The effect of heating in the MRI-environment for overlapping stents is not known.

MRI-Related Artifacts

MRI-image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the implant / device. Therefore, optimisation of MR imaging parameters to compensate for the presence of this implant / device may be necessary.

[1] ASTM F2503-13, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

[2] Shellock FG, “Biomedical Implants and Devices: Assessment of Magnetic Field Interactions with a 3.0-Tesla MR System. Journal of Magnetic Resonance Imaging, 2002”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-Obliquus stent system is used to introduce a self-expanding nitinol stent into the peripheral vascular system using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Failure of the stent or stent application system
Allergic reactions
Erroneous implantation of the stent
Inadequate anchorage
Stent migration or stent embolisation
Dislocation due to insufficient stent diameters
Bleeding
Pain
Haematoma
Renal failure
Fracture of the stent
Acute thrombosis in cases of lack of perfusion (e.g. spasms or other occlusions) of the passage vessels and insufficient anticoagulation
Stroke
Stent closure
Vascular damage including dissection and rupture
Haemorrhage
Infection
Formation of arteriovenous fistula
Tissue necrosis
Pyrexia
Hypertension or hypotension
Ischaemia
Perfusion limitations in lateral branches of arteries or veins or distal vessels
Reperfusion damage including cardiac or pulmonary dysfunction caused by abrupt change to haemodynamics, including cardiac arrest and pulmonary failure or pulmonary embolism
Cerebrovascular dysfunction
Organ failure
Complications at vascular entrance such as pseudo aneurysms or haematoma
Restenosis
Hypersensitive reactions
Cardiac and cardiovascular dysfunction, e.g. myocardial infarction
Death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-Venous

MR Compatibility:

The implant / device was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-13. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

MRI-Related Displacement Force and Torque

A scientific investigation [1, 2] demonstrated that implant / device made out of nitinol and /or tantalum are MR Conditional. A patient with this implant/device can be scanned safely immediately after placement under the following conditions:

Static magnetic field of 3.0-Tesla or less

MRI-Related Heating

In non-clinical testing, the implant /device produced the following temperature rises when MRI was performed for 9 min at 1.5 Tesla (Intera, Philips Medical Systems (PMS), Software 12.6.1.4) and performed for 15 min. at 3 Tesla (Signa Hdxt, General Electric (GE) Medical Systems, Software 15.0_M4_0910.a) and at an average whole-body SAR of 3 W/kg registered by the MRI system.

Highest temperature change MRI Condition:

Less than or equal to 4.0 degrees C at 1.5-Tesla
Less than or equal to 4.0 degrees C at 3.0-Tesla

Remark: The effect of heating in the MRI environment for overlapping stents is not known.

MRI-Related Artifacts

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the implant / device. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant/device may be necessary.

[1] ASTM F2503-13, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

[2] Shellock FG, “Biomedical Implants and Devices: Assessment of Magnetic Field Interactions With a 3.0-Tesla MR System. Journal of

Magnetic Resonance Imaging, 2002”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-Venous stent system is used to introduce a self-expanding nitinol stent into the peripheral vascular system using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Failure of the stent or stent application system
Allergic reactions
Malimplantation of the stent

Inadequate anchorage
Stent migration or stent embolisation
Dislocation due to insufficient stent diameters
Bleeding
Pain
Haematoma
Renal failure
Fracture of the stent
Acute thrombosis in cases of lack of perfusion (e.g. spasmus or other occlusions) of the passage vessels and insufficient anticoagulation
Stroke
Stent obliteration
Vascular damage including dissection and rupture
Haemorrhage
Infection
Formation of arteriovenous fistula
Tissue necrosis
Death
Pyrexia
Hypertension or hypotension
Ischaemia
Perfusion limitations in lateral branches of arteries or veins or distal vessels
Reperfusion damage including cardiac or pulmonary dysfunction caused by abrupt change to haemodynamics, including cardiac arrest and pulmonary failure or pulmonary embolism
Cerebrovascular dysfunction
Cardiac and cardiovascular dysfunction, e.g. myocardial infarction
Organ failure
Complications at vascular entrance such as pseudoaneurysm or haematoma
Restenosis
Hypersensitive reactions

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-XL 6F

MR Compatibility:

Non-clinical trials [1] have shown that the sinus-XL 6F stent is MR Conditional for lengths (single or overlapped stents) of up to 100 mm in accordance with the guidelines set forth in the American Society for Testing Materials ASTM F2503-13 (Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment).

A patient with this stent can safely be scanned in an MR system meeting the following conditions:

Static magnetic field of 1.5 Tesla or 3 Tesla
Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
Maximum MR system reports whole body averaged specific absorption rate (SAR) of up to 2 W/kg

Note: The effect of heating in the MRI environment for overlapping stents longer than 100 is not known.

Under the scan conditions defined above (positioned at isocentre), a stent of worst-case length (including two overlapping stents) is expected to produce a maximum temperature rise of up to 5.8 °C after 15 minutes of continuous scanning. The actual in vivo rise is expected to be less than these values as the calculations did not include the cooling effects due to blood flow in the lumen of the stent and blood perfusion in the tissue outside the stent.

In non-clinical testing, the image artefact caused by the device extends approximately 5 mm from the stent when imaged with a gradient echo pulse sequence and a 3.0 Tesla MR system. The artefact may obscure the stent lumen.

[1] ASTM F2503-13, “Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-XL 6F stent system is used to introduce a self-expanding nitinol stent into the central vascular system using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Stent collapse/inadequate anchorage/dislocation due to insufficient diameter of the stent
Stent fails to expand evenly/to the specified diameter, stent kinking
(In-stent) Restenosis
Stent embolisation
Stent migration
Stent fracture
Haemorrhage/haematoma in insertion area
Haemorrhage, general
Acute thrombosis in cases of lack of perfusion (e.g. spasms or other occlusions) of the runoff vessels and insufficient anticoagulation
Blood pressure dysregulation
Cardiac dysrhythmia up to complete cardiac arrest, myocardial infraction, pericardial tamponade and death
Allergic/hypersensitive reaction to contrast medium or nickel
Respiratory complaints and pulmonary failure up to complete respiratory arrest and death
Infection
Sepsis
Inflammation
Fever
Necrosis
Embolism (peripheral and pulmonary)
Damage to vessels (dissection, perforation, rupture, haematoma, lesion, pseudoaneurysm, arteriovenous fistula, distention of target area)
Vascular spasm
Ischaemia
Intimal hyperplasia
Pain
Organ failure, e.g. renal failure
Cerebrovascular dysfunction up to stroke and death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-XL Flex

MR Compatibility:

Non-clinical trials [1] have shown that the sinus-XL Flex stent is MR Conditional for lengths (single or overlapped stents) of up to 160 mm in accordance with the guidelines set forth in the American Society for Testing Materials ASTM F2503-13 (Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment).

A patient with this stent can safely be scanned in an MR system meeting the following conditions:

Static magnetic field of 1.5 Tesla or 3 Tesla
Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
Maximum MR system reports whole body averaged specific absorption rate (SAR) of up to 2 W/kg

Note: The effect of heating in the MRI environment for overlapping stents longer than 160 is not known.

Under the scan conditions defined above (positioned at isocentre), a stent of worst-case length (including two overlapping stents) is expected to produce a maximum temperature rise of up to 4.0 °C after 15 minutes of continuous scanning. The actual in vivo rise is expected to be less than these values as the calculations did not include the cooling effects due to blood flow in the lumen of the stent and blood perfusion in the tissue outside the stent.

[1] ASTM F2503-13, “Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-XL Flex stent system is used to introduce a self-expanding nitinol stent into the central vascular system using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Stent collapse/inadequate anchorage/dislocation due to insufficient diameter of the stent
Stent fails to expand evenly/to the specified diameter, stent kinking
(In-stent) Restenosis
Stent embolisation
Stent migration
Stent fracture
Haemorrhage/haematoma in insertion area
Haemorrhage, general
Acute thrombosis in cases of lack of perfusion (e.g. spasms or other occlusions) of the runoff vessels and insufficient anticoagulation
Blood pressure dysregulation
Cardiac dysrhythmia up to complete cardiac arrest, myocardial infraction, pericardial tamponade and death
Allergic/hypersensitive reaction to contrast medium or nickel
Respiratory complaints and pulmonary failure up to complete respiratory arrest and death
Infection
Sepsis
Inflammation
Fever
Necrosis
Embolism (peripheral and pulmonary)
Damage to vessels (dissection, perforation, rupture, haematoma, lesion, pseudoaneurysm, arteriovenous fistula, distention of target area)
Vascular spasm
Ischaemia
Intimal hyperplasia
Pain
Organ failure, e.g. renal failure
Cerebrovascular dysfunction up to stroke and death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-XL

MR Compatibility:

Non-clinical trials [1] have shown that the sinus-XL stent is MR Conditional for individual and overlapping lengths of up to 180 mm in accordance with the guidelines set forth in the American Society for Testing Materials ASTM F2503-13 (Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment).

A patient with this stent can safely be scanned in an MR system meeting the following conditions:

Static magnetic field of 1.5 Tesla or 3 Tesla
Maximum spatial gradient magnetic field of 4,500 gauss/cm (45 T/m)
Maximum MR system reports whole body averaged specific absorption rate (SAR) of up to 1.3 W/kg

Under the scan conditions defined above (positioned at isocentre), a stent of worst-case length (including two overlapping stents) is expected to produce a maximum temperature rise of up to 6.6 °C after 15 minutes of continuous scanning. The actual in vivo rise is expected to be less than these values as the calculations did not include the cooling effects due to blood flow in the lumen of the stent and blood perfusion in the tissue outside the stent.

[1] ASTM F2503-13, “Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-XL stent system is used to introduce a self-expanding nitinol stent into the central vascular system using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Stent collapse/inadequate anchorage/dislocation due to insufficient diameter of the stent
Stent fails to expand evenly/to the specified diameter, stent kinking
(In-stent) Restenosis
Stent embolisation
Stent migration
Stent fracture
Haemorrhage/haematoma in insertion area
Haemorrhage, general
Acute thrombosis in cases of lack of perfusion (e.g. spasms or other occlusions) of the runoff vessels and insufficient anticoagulation
Blood pressure dysregulation
Cardiac dysrhythmia up to complete cardiac arrest, myocardial infraction, pericardial tamponade and death
Allergic/hypersensitive reaction to contrast medium or nickel
Respiratory complaints and pulmonary failure up to complete respiratory arrest and death
Infection
Sepsis
Inflammation
Fever
Necrosis
Embolism (peripheral and pulmonary)
Damage to vessels (dissection, perforation, rupture, haematoma, lesion, pseudoaneurysm, arteriovenous fistula, distention of target area)
Vascular spasm
Ischaemia
Intimal hyperplasia
Pain
Organ failure, e.g. renal failure
Cerebrovascular dysfunction up to stroke and death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

Arterial Stents:

sinus-SuperFlex-418

MR Compatibility:

MRI-Related Displacement Force and Torque

Static magnetic field of 3.0-Tesla or less

MRI-Related Heating

In non-clinical testing, the implant /device produced the following temperature rises when MRI was performed for 1 min at 1.5 Tesla (Intera, Philips Medical Systems (PMS), Software 12.6.1.4) and performed for 13 min. at 3 Tesla (Signa Hdxt, General Electric (GE) Medical Systems, Software 15.0_M4_0910.a) and at an average whole-body SAR of 3 W/kg registered by the MRI system.

Highest temperature change MRI Condition:

Less than or equal to 4.0 degrees C at 1.5-Tesla
Less than or equal to 4.0 degrees C at 3.0-Tesla

Remark: The effect of heating in the MRI environment for overlapping stents is not known.

MRI-Related Artifacts

[1] ASTM F2503-13, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

[2] Shellock FG, “Biomedical Implants and Devices: Assessment of Magnetic Field Interactions With a 3.0-Tesla MR System. Journal of

Magnetic Resonance Imaging, 2002”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-SuperFlex-418 Stent System is used to introduce a self-expanding nitinol stent into the arterial vascular system of the pelvis/lower extremities using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Malimplantation of the stent
Ill-adapted anchorage /Dislocation due to too small stent diameters
Stent fracture
Acute thrombosis in case of missing perfusion (e.g., spasms or other blockages) of the passage vessels as well as insufficient anticoagulation
Blood pressure dysregulation
Cardiac arrhythmia up to cardiac arrest
Allergic reaction to contrast agents
Breathing difficulties up to respiratory arrest
Hemorrhage
Infection /Sepsis
Perforation
Bleeding or hematoma at the puncture site
Peripheral embolization
Formation of fistulas or aneurysms
Arterial spasms
Residual stenosis in the further course of the disease
Death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-SuperFlex-518

MR Compatibility:

MRI-Related Displacement Force and Torque

A scientific investigation [1, 2] demonstrated that implant / device made out of nitinol and/or tantalum are MR Conditional. A patient with this implant / device can be scanned safely immediately after placement under the following conditions:

Static magnetic field of 3.0-Tesla or less

MRI-Related Heating

In non-clinical testing, the implant / device produced the following temperature rises when MRI was performed for 3 min at 1.5 Tesla (Intera, Philips Medical Systems (PMS), Software 12.6.1.4) and performed for 15 min. at 3 Tesla (Signa Hdxt, General Electric (GE) Medical Systems, Software 15.0_M4_0910.a) and at an average whole-body SAR of 3 W/kg registered by the MRI system.

Highest temperature change MRI Condition:

Less than or equal to 4.0 degrees C at 1.5-Tesla
Less than or equal to 4.0 degrees C at 3.0-Tesla

Remark: The effect of heating in the MRI environment for overlapping stents is not known.

MRI-Related Artifacts

[1] ASTM F2503-13, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

[2] Shellock FG, “Biomedical Implants and Devices: Assessment of Magnetic Field Interactions With a 3.0-Tesla MR System. Journal of Magnetic Resonance Imaging, 2002”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-SuperFlex-518 Stent System is used to introduce a self-expanding nitinol stent into the arterial vascular system of the pelvis/lower extremities using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Malimplantation of the stent
Inadequate anchorage / dislocation due to insufficient diameter of the stent
Stent migration
Lesion / perforation of vascular wall
Vascular spasms
Haemorrhage / haematoma in insertion area
Stent fracture
Acute thrombosis in cases of lack of perfusion (e.g. spasms or other occlusions) of the passage vessels and insufficient anticoagulation
Peripheral embolisation
Blood pressure dysregulation
Cardiac dysrhythmia up to complete cardiac arrest
Allergic reaction to contrast media
Respiratory complaints up to complete respiratory arrest
Haemorrhage
Infection / sepsis
Dissection
Death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-SuperFlex-535

MR Compatibility:

The implant/device was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-13. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

MRI-Related Displacement Force and Torque

A scientific investigation [1] demonstrated that implant/device made out of nitinol are MR Conditional. A patient with this implant/device can be scanned safely immediately after placement under the following conditions:

Static magnetic field of 1.5-Tesla or less

MRI-Related Heating

A scientific investigation [1] demonstrated that implant/device made out of nitinol are MR Conditional. A patient with this implant/device can be scanned under the following conditions:

Static magnetic field of 1.5-Tesla or less

MRI-Related Artifacts

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the implant/ device. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant/device may be necessary.

[1] Sawyer-Glover AM, Shellock FG, “Pre-MRI Procedure Screening: Recommendations and Safety Considerations for Biomechanical Implants and Devices, Journal of Magnetic Resonance Imaging, 2000”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-SuperFlex-535 Stent System is used to introduce a self-expanding nitinol stent into the arterial vascular system of the pelvis/lower extremities using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Malimplantation of the stent
Insufficient anchorage / Dislocation due to insufficient stent diameter
Lesions / Perforation of vascular wall
Stent fracture
Subsequent restenosis
Bleeding and haematoma in puncture area
Acute thrombosis of stent or treated vascular section in the event of lack of perfusion (e.g. arterial spasms or other blockages) of the passage
vessels and insufficient anticoagulation
Peripheral embolisation
Stent migration
Allergic reaction to contrast medium
Development of fistulas and aneurysms
Haemorrhagia
Blood pressure dysregulation
Breathing difficulties up to apnoea
Infection / Sepsis
Death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-SuperFlex-635

MR Compatibility:

MRI-Related Displacement Force and Torque

A scientific investigation [1, 2] demonstrated that implant / device made out of nitinol and/or tantalum are MR Conditional. A patient with this implant / device can be scanned safely immediately after placement under the following conditions:

Static magnetic field of 3.0-Tesla or less

MRI-Related Heating

Highest temperature change MRI Condition:

Less than or equal to 4.0 degrees C at 1.5-Tesla
Less than or equal to 4.0 degrees C at 3.0-Tesla

Remark: The effect of heating in the MRI environment for overlapping stents is not known.

MRI-Related Artifacts

[1] ASTM F2503-13, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

[2] Shellock FG, “Biomedical Implants and Devices: Assessment of Magnetic Field Interactions With a 3.0-Tesla MR System. Journal of Magnetic Resonance Imaging, 2002”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-SuperFlex-635 Stent System is used to introduce a self-expanding nitinol stent into the arterial vascular system of the pelvis/lower extremities using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Malimplantation of the stent
Inadequate anchorage / dislocation due to insufficient diameter of the stent
Stent migration
Lesion / perforation of vascular wall
Vascular spasms
Haemorrhage / haematoma in insertion area
Stent fracture
Acute thrombosis in cases of lack of perfusion (e.g. spasms or other occlusions) of the passage vessels and insufficient anticoagulation
Peripheral embolisation
Blood pressure dysregulation
Cardiac dysrhythmia up to complete cardiac arrest
Allergic reaction to contrast media
Respiratory complaints up to complete respiratory arrest
Haemorrhage
Infection / sepsis
Dissection
Death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-Repo-Visual 6F

MR Compatibility:

MRI-Related Displacement Force and Torque

Static magnetic field of 3.0-Tesla or less

MRI-Related Heating

In non-clinical testing, the implant /device produced the following temperature rises when MRI was performed for 15 min at 1.5 Tesla (Intera, Philips Medical Systems (PMS), Software 12.6.1.4) and performed for 3 min. at 3 Tesla (Signa Hdxt, General Electric (GE) Medical Systems, Software 15.0_M4_0910.a) and at an average whole-body SAR of 3 W/kg registered by the MRI system.

Highest temperature change MRI Condition:

Less than or equal to 4.0 degrees C at 1.5-Tesla
Less than or equal to 4.0 degrees C at 3.0-Tesla

Remark: The effect of heating in the MRI environment for overlapping stents is not known.

MRI-Related Artifacts

[1] ASTM F2503-13, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

[2] Shellock FG, “Biomedical Implants and Devices: Assessment of Magnetic Field Interactions With a 3.0-Tesla MR System. Journal

of Magnetic Resonance Imaging, 2002”

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-Repo-Visual 6F Stent System is used to introduce a self-expanding nitinol stent into the arterial vascular system of the pelvis/lower extremities using the application device. The stent itself has the purpose of increasing the lumen diameter of the target vessel and improving blood flow.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Stent collapses/inadequate anchorage/dislocation due to insufficient diameter of the stent
Stent does not expand uniformly/to specified diameter, stent kinking
(In-stent) Restenosis
Stent embolisation
Stent migration
Stent fracture
Haemorrhage/haematoma in insertion area
Haemorrhage in general
Acute thrombosis in cases of lack of perfusion (e.g. spasms or other occlusions) of the passage vessels and insufficient anticoagulation
Blood pressure dysregulation
Cardiac dysrhythmia up to complete cardiac arrest
Allergic reaction to contrast medium or nickel
Respiratory complaints up to complete respiratory arrest
Infection
Sepsis
Inflammation
Fever
Necrosis
Embolism
Damage to vessels (dissection, perforation, rupture, haematoma, lesion)
Vascular spasm
Ischaemia
Intimal hyperplasia
Pain
Death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-SuperFlex-DS

MR Compatibility:

Non-clinical trials [1] have shown that the sinus-SuperFlex-DS stent is MR Conditional for individual and overlapping lengths of up to 50 mm in accordance with the guidelines set forth in the American Society for Testing Materials ASTM F2503-13 (Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment).

A patient with this stent can safely be scanned in an MR system meeting the following conditions:

Static magnetic field of 1.5 Tesla or 3 Tesla
Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
Maximum MR system reports whole body averaged specific absorption rate (SAR) of up to 2 W/kg

Under the scan conditions defined above (positioned at isocentre), a stent of worst-case length (including two overlapping stents) is expected to produce a maximum temperature rise of up to 6.0 °C after 15 minutes of continuous scanning. The actual in vivo rise is expected to be less than these values as the calculations did not include the cooling effects due to blood flow in the lumen of the stent and blood perfusion in the tissue outside the stent.

[1] ASTM F2503-13, “Standard Practice Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”

kind of patient on whom the device is intended to be used:

Neonates

intended performance of the device:

The sinus-SuperFlex DS stent system is used to introduce a self-expanding nitinol stent into the central vascular system using the application device. The stent itself has the purpose to restore or maintain patency of the ductus arteriosus botalli.

possible complications:

Stent collapse/inadequate anchorage/dislocation due to insufficient diameter of the stent
Stent fails to expand evenly/to the specified diameter, stent kinking
(In-stent) Restenosis
Stent embolisation
Stent migration
Stent fracture
Haemorrhage/haematoma in insertion area
Haemorrhage, general
Acute thrombosis
Blood pressure dysregulation, e.g. hypotension
Cardiac dysrhythmia up to complete cardiac arrest, myocardial infraction, pericardial tamponade and death
Allergic/hypersensitive reaction to contrast medium or nickel
Respiratory complaints and pulmonary failure up to complete respiratory arrest and death
Infection
Sepsis
Inflammation
Fever
Necrosis
Embolism (peripheral and pulmonary)
Damage to vessels (dissection, perforation, rupture, haematoma, lesion, pseudoaneurysm, arteriovenous fistula, distention of target area)
Damage to heart valve possible, cardial arrhythmia up to cardiac arrest
Vascular spasm
Ischaemia
Intimal hyperplasia
Pain
Organ failure, e.g. renal failure
Occlusion of the ductus arteriosus
Cerebrovascular dysfunction up to stroke and death

the expected device lifetime:

the maximum indwelling time is 1 year

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

sinus-Reduction

MR Compatibility:

No data available

kind of patient on whom the device is intended to be used:

Adults (fully grown)

intended performance of the device:

The sinus-Reduction Stent System is used to introduce a self-expanding nitinol stent into the central vascular system using the application device. The stent itself has the purpose of decreasing the lumen diameter of the target vessel and reducing blood flow after TIPS stent insertion.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include:

Malimplantation of the stent
Lesions of vascular wall
Inadequate anchorage / dislocation due to incorrect diameter of the ReductionStent
Recurrent haemorrhage (primarily oesophageal varices) from excessive reduction of TIPS shunt diameter
Recurrent symptoms of portal hypertension and / or deterioration of liver function from excessive reduction of TIPS shunt diameter
Haemodynamic complications (e.g. thrombosis of tract, possible detachment of thrombus resulting in pulmonary artery embolism)
Stent obstruction
Stent fracture
Infection
Death

the expected device lifetime:

The product is an implant that normally remains in the body for life.

the materials and substances included in the device:

Stent: Nitinol/Tantal

Introducer sheath: Pebax

a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA:

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA.

the address of the Therapeutic Goods Administration’s website:

https://www.tga.gov.au

Click here, to print these information.

Information on MR compatibility related to optimed ureteral stents

Urology:

Ureteral Stents:

MR Compatibility:

The ureteral stents (except "Ex-stent" tumor stent) are made of plastic material; therefore, they are MR Safe according to

ASTM F 2503-2020. The materials are electrically nonconductive, nonmetallic and nonmagnetic.

The Ex-stent tumor ureteral stents contain two small marker bands made of platinum-iridium, these marker bands are very small and nonmagnetic. Since we have not performed any MR tests on the parts, we cannot make any statement about safety in the MR environment, including conditions for the static magnetic field, the time-varying gradient magnetic fields and the radiofrequency fields according to

ASTM F 2503-2020.

kind of patient on whom the device is intended to be used:

Adults

Children

Neonates

intended performance of the device:

Ureteral stents are used to ensure the patency of a ureter, which may be compromised, for example, by a kidney stone or a procedure.

possible complications:

Only doctors familiar with the possible complications may apply this product. Complications may occur at any time during or following the procedure. Possible complications include: