Covidien has released positive final results from its DURABILITY II study and promising preliminary data from its DEFINITIVE AR Peripheral Artery Disease (PAD) trial involving some of its technologies. The results are sure to fuel its ongoing push into the peripheral vascular therapy area.
Vascular
It’s VIVA Las Vegas for Veryan’s 3D Vascular Stent as Data Suggest Patency Protective Effect
Data presented at VIVA13 , taking place in Las Vegas this week has demonstrated safety and promising clinical performance at twelve months in the treatment of patients with peripheral arterial disease undergoing femoropopliteal artery intervention using Veryan Medical’s BioMimics 3D™ stent.
FDA Clearance for Novel 5 Lumen Occlusion Perfusion Catheter
Advanced Catheter Therapies, Inc. has gained FDA clearance for its clever multi-lumen Occlusion Perfusion Catheter™. The device enables the operating physician to occlude and isolate a section of vessel and deliver a therapeutic agent in a controlled and effective manner.
US Launch for Terumo’s Detachable AZUR® CX Peripheral Vascular Coil
Terumo describes its newly launched Azur CX as the first and only Peripheral Coil designed for cross-sectional coverage incorporating the benefits of Terumo® patented hydrogel technology. The hydrogel confers flexibility and swells to stabilise the coil in the vessel.
Medtronic’s Complete ‘SE’ Vascular Stent sees FDA Expand Indications Down the Leg
Peripheral Vascular Stent options in the US now include Medtronic’s Complete SE offering which has seen its indication extended to include the superficial femoral and proximal popliteal vessels.
Report Points to Potential Impact of BioMimics 3D™ Peripheral Vascular Stent
The UK’s National Institute for Health Research (NIHR) has issued a technical report pointing to the potential for Veryan Medical’s BioMimics 3D™ Stent. It focuses on the potential advantage of a spiral stent that mimics the shape of a native vessel, but being a government body rather ducks the issue of whether it’s any good, leaving us wondering what use this report really is.
First PMA Module Submitted for Varicose Vein Sealant System
Sapheon Inc. has submitted the first module of the pre-market approval application for the VenaSeal® Sapheon Closure System to the U.S. FDA. Sapheon expects to be launching its product in the first half of 2015.
New Marketing VP at InspireMD
Embolic protection stent developer, InspireMD Inc. has announced David Blossom as Vice President of Global Marketing and Strategy. Blossom will be responsible for a global strategic marketing plan that addresses the emerging coronary, carotid and multiple vascular opportunities before the Company.
Vital Access Corp Announces FDA Clearance Of VWING™ Vascular Needle Guide
Vital Access Corp. has received U.S. FDA market clearance for its patented VWING™ Vascular Needle Guide which has been shown to enable vascular access to arteriovenous fistulas for patients undergoing hemodialysis.
Study Questions Physician Drug-Coated-Balloon Practices
Who’s responsible for ensuring devices get used correctly, according to manufacturers’ instructions? A new survey suggests companies might have to work harder to educate vascular specialists about how to get best results from peripheral drug-eluting balloons.
Gore’s U.S Carotid Stent Study Underway
W. L. Gore & Associates has enrolled a first patient in its GORE® Carotid Stent Clinical Study. Tagged SCAFFOLD, the study will compare Gore’s stent with traditional carotid endarterectomy data.
First for Gore as FDA Approves Prosthesis for Endovascular Repair of Aortic Dissection
W. L. Gore & Associates has gained FDA approval for its Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This durable endoprosthesis is the only device to receive FDA approval for this indication and is designed for multiple thoracic etiologies.
Sapheon Raises $19.8 Million as Pivotal Study Completes Enrollment
North Carolina company Sapheon Inc. has announced that it has raised $19.8 million, which will support its U.S. pivotal study through final submission to the FDA of the PMA application for the VenaSeal Sapheon Closure System®.
European Clot Management Device Market To Exceed $170 Million By 2022
According to global market intelligence company Millennium Research Group, the European market for clot management devices will see moderate growth through 2022. Although a number of segments are mature, fast-growing segments such as endovascular treatments for acute ischemic stroke and venous thromboembolism underpin the growth forecast.
Bayer’s Jetstream™ Atherectomy System Brings Active Aspiration to European Markets
The Medical Care division of Bayer HealthCare is introducing its Jetstream™ Atherectomy System at the next week’s annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Lisbon, Portugal. The device can be used to treat a wide range of vessel diameters and features continuous active aspiration.
CE Mark for Avinger Pantheris, Visual Atherectomy System
Newly CE marked, Pantheris is the first-ever lumectomy catheter for image-guided atherectomy to treat patients with Peripheral Artery Disease.