Terumo (TSE: 4543) is proud to announce that both of our Vascular Closure Devices, Angio-Seal™ VIP & Femoseal™, received the EU MDR certifications.
This is result of a fruitful collaboration between Terumo and the Notified Body NSAI (CE 0050).
The first CE marked units of Femoseal™ reached the market in June 2023. The first CE marked units of Angio-Seal™ VIP are expected to reach the market in November 2023, as we are finalizing the transition process to update MDR labels and IFU.
This certification authenticates the value of Angio-Seal™ VIP & Femoseal™ to achieve femoral arterial hemostasis after percutaneous catheterization through the common femoral artery and represents an important milestone for Terumo Interventional Systems, as we remain dedicated to improving patient care in everything we do.
If you have questions, please contact your local Terumo representative.
Angio-Seal™ VIP is a vascular closure device consisting of a bovine-derived bioabsorbable collagen plug and a specially designed bioabsorbable polymer anchor that are connected by a bioabsorbable self-tightening suture. Hemostasis is achieved by the mechanical means of the anchor-arteriotomy-collagen sandwich.
Angio-Seal™ VIP provides a reduction in time to hemostasis1 and time to ambulation1 after common femoral arterial puncture. Angio-Seal™ Vascular Closure Device is indicated for use in closing and reducing time to hemostasis at the common femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8Fr Angio-Seal™ device and a 6 French or smaller procedural sheath for the 6Fr Angio-Seal™ device.
Angio-Seal™ Vascular Closure Device is also indicated for use to allow patients who have undergone diagnostic angiography and/or interventional procedures to ambulate safely as soon as possible after sheath removal and device placement.
Angio-Seal™ VIP Vascular Closure Device (terumo-europe.com)
FemoSeal™ is a resorbable vascular closure device consisting of two resorbable polymer discs, the inner seal and the outer locking disc which are held together by a resorbable multifilament, thereby mechanically sealing the arteriotomy.
FemoSeal™ VCS provides a reduction in time to hemostasis2 and time to ambulation2 after common femoral arterial puncture.
FemoSeal™ Vascular Closure System is indicated for use in closing the common femoral arterial puncture (arteriotomy) in patients who have undergone percutaneous catheterization using a 7F (2.33 mm) or smaller procedure sheath.
FemoSeal™ Vascular Closure System (terumo-europe.com)
Terumo Europe N.V. is a core player in the EMEA healthcare market by providing best-in-class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets, and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Hospital Care Solutions, Cardiovascular and Life Care Solutions. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA.
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
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