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Implants

Terumo begins limited release of Roadsaver carotid stent following FDA nod

May 29, 2025 By Danielle Kirsh

Terumo Roadsaver.

Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System. Roadsaver is a dual-layer micromesh carotid stent designed to reduce embolic risk during carotid artery stenting (CAS) procedures. It is indicated for use in patients with carotid artery stenosis who are at increased … [Read more...] about Terumo begins limited release of Roadsaver carotid stent following FDA nod

Filed Under: Applications, Cardiology, Catheters, Implants, Regulatory, Stents, Technologies & Devices Tagged With: nitinol, Terumo, Terumo Interventional Systems

CereVasc study data backs eShunt system

February 5, 2025 By Sean Whooley

Cerevasc-Logo

CereVasc today announced initial results from a pilot clinical study supporting the use of its eShunt system. Boston-based CereVasc designed eShunt for treating normal pressure hydrocephalus (NPH). This study evaluates the technology in the treatment of elderly patients with NPH. eShunt has FDA breakthrough device designation, which it picked up … [Read more...] about CereVasc study data backs eShunt system

Filed Under: Implants, Materials, Nitinol, Shunts Tagged With: CereVasc, nitinol

Xeltis completes enrollment in vascular access conduit study

January 7, 2025 By Sean Whooley

Xeltis aXess vascular access conduit

Xeltis announced today that it completed enrollment in an EU pivotal trial for aXess, its restorative vascular access conduit. The study evaluates aXess in adults with end-stage renal disease. Eindhoven, The Netherlands-based Xeltis will conduct the study in 120 subjects across 22 centers in Europe. This study follows 12-month data from a … [Read more...] about Xeltis completes enrollment in vascular access conduit study

Filed Under: Business, Catheters, Implants, Personnel Moves, Technologies & Devices Tagged With: Xeltis

R3 Vascular wins FDA IDE for drug-eluting scaffold

November 4, 2024 By Sean Whooley

R3 Vascular Logo

R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK … [Read more...] about R3 Vascular wins FDA IDE for drug-eluting scaffold

Filed Under: Applications, Cardiology, Implants, Regulatory, Stents, Technologies & Devices Tagged With: fda, R3 Vascular

Medinol has first human implant of drug-eluting peripheral stent in Australia

October 7, 2024 By Sean Whooley

Medinol ChampioNIR drug-eluting stent

Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent. Dr. Gerard S. Goh and Dr. Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, completed the stent implant. The company says it introduces a "revolutionary advancement" in the mechanics, durability and drug delivery of … [Read more...] about Medinol has first human implant of drug-eluting peripheral stent in Australia

Filed Under: Implants, Stents, Technologies & Devices Tagged With: Medinol, nitinol

Merit Medical to buy Cook Medical’s lead management portfolio

September 17, 2024 By Sean Whooley

Merit Medical Logo

Merit Medical Systems (Nasdaq:MMSI) announced today that it agreed to acquire Cook Medical's lead management portfolio for $210 million. Cook Medical's lead management business provides medical devices and accessories used in lead management procedures. These procedures occur in patients who need a pacemaker or an implantable … [Read more...] about Merit Medical to buy Cook Medical’s lead management portfolio

Filed Under: Applications, Business, Cardiac Implants, Cardiology, Catheters, Implants, Mergers & Acquisitions, Technologies & Devices Tagged With: Cook Medical, Merit Medical

FDA approves expanded label for Boston Scientific Ingevity+ pacing leads

September 17, 2024 By Sean Whooley

Boston Scientific Ingevity+ pacing lead (1)

Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads. The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when the pacing leads — thin wires placed … [Read more...] about FDA approves expanded label for Boston Scientific Ingevity+ pacing leads

Filed Under: Applications, Cardiology, Catheters, Implants, Regulatory, Technologies & Devices Tagged With: Boston Scientific, fda

InspireMD submits carotid stent for FDA premarket approval

September 16, 2024 By Sean Whooley

inspiremd

InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system, made from nitinol, for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company's C-GUARDIANS … [Read more...] about InspireMD submits carotid stent for FDA premarket approval

Filed Under: Implants, Materials, Nitinol, Pre-Market Approval (PMA), Regulatory, Stents Tagged With: InspireMD, nitinol

Renata Medical announces first growth stent implant following FDA approval

September 4, 2024 By Sean Whooley

Renata Medical Minima Stent

Renata Medical announced the first completed implantation of its Minima growth stent for young children after winning FDA approval. Newport Beach, California-based Renata picked up FDA approval for the first-of-its-kind stent last week. The company designed the stent to re-expand over the course of the child’s growth period. “Today marks the … [Read more...] about Renata Medical announces first growth stent implant following FDA approval

Filed Under: Applications, Cardiology, Implants, Stents, Technologies & Devices Tagged With: Renata Medical

Renata Medical wins FDA nod for first-of-its-kind stent for young children

August 29, 2024 By Sean Whooley

Renata Medical Minima Stent

Renata Medical today said the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the stent to re-expand over the course of the child’s growth period. The company says its approval marks a “groundbreaking advancement” in care for young children … [Read more...] about Renata Medical wins FDA nod for first-of-its-kind stent for young children

Filed Under: Applications, Cardiology, Implants, Regulatory, Stents, Technologies & Devices Tagged With: fda, Renata Medical

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