The first implants of a novel aortic stent graft for use where aneurysms include sidebranches, have been performed under a new FDA early feasibility pilot program, designed to encourage more early-stage clinical research on new medical devices.
Vascular
Cook Medical Recalls Zilver® PTX® Stent For Delivery System Problems
Cook Medical’s aspirations with its Zilver® PTX® drug-eluting stent have been somewhat dented temporarily by the need to voluntarily recall the device following problems with its delivery device.
Japan Here We Come As TriReme’s Glider™ PTCA Catheter Gets Shonin Nod
TriReme has announced that its Japanese partner, Century Medical, Inc. (CMI), has received Shonin approval for the Glider™ PTCA catheter indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion. Glider™ is the world’s only torqueable PTCA catheter and is designed to address challenging cases such as bifurcations and highly stenosed lesions.
First Fully Percutaneous EVAR Approval From FDA
A solid set of clinical data underpins FDAs decision to extend Endologix’s FDA approval to include so-called percutaneous endovascular repair (PEVAR) of triple AAAs. Seems the procedure is quicker, safer, less painful and requires fewer transfusions than EVAR.
FDA Clears CryoLife’s New HeRO Dialysis Device
CryoLife, Inc. has received U.S. FDA 510(k) clearance for its next generation HeRO (Hemodialysis Reliable Outflow) device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access for end-stage renal disease (ERSD) hemodialysis patients with central venous stenosis.
CE Mark For Thoracic-Length Heli-FX Aortic Aneurysm Graft System
Aptus Endosystems has gained CE mark approval for the thoracic version of its Heli-FX™ endovascular aneurysm repair graft. The the new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor™ technology to the treatment of thoracic aortic aneurysms.
Cook Medical Starts Iliofemoral Venous Stent Study
Cook Medical has launched the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Self-Expanding Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Medtronic’s Newly CE Marked AAA Stent Graft Introducer Sheath Showcased At CX Symposium This Weekend
This weekend (April 6-9) sees the 35th running of the Charing Cross Vascular Symposium in London. Medtronic has just received CE mark approval for its new AAA stent graft introducer sheath and will be showcasing it among its other offerings at the event.
FDA Clears SAM Junctional Tourniquet
The SAM Junctional Tourniquet has been FDA 510(k) cleared for market. The device is designed to control bleeding where standard tourniquets would not be effective.
Complex TEVAR Procedure Training Simulator FDA Approved
Training simulator company Simbionix USA Corporation, has received FDA clearance for its TEVAR application for PROcedure Rehearsal Studio™ . This application joins the family of PRS cleared for marketing applications for Carotid Intervention and EVAR procedures.
Percutaneous CV Device Co Gains Chinese Distribution Deal
CV device company TriReme has announced the signing of a comprehensive agreement with Weihai Weigao Medical Devices, Ltd for the distribution of its products in the People’s Republic of China. Weigao will act as TriReme’s master distributor by selling TriReme products directly to hospitals as well as connecting TriReme products into its vast nationwide distribution network.
ROX Medical’s Resistant Hypertension Trial Under Way In London
London’s Barts Hospital has enrolled its first patients in the ROX Medical CONTROL-HTN international randomized controlled hypertension trial. The study is evaluating the ROX FLOW procedure, which creates a small connection between artery and vein in the upper leg for the treatment of resistant hypertension.
CE Mark For InspireMD’s Carotid Embolic Protection Stent
Adding to its portfolio of embolus-preventing coronary stents, Israeli company InspireMD has now gained CE mark approval for its carotid equivalent which it says holds plaque and thrombus in place against the wall of the blocked artery, preventing debris from falling into the bloodstream and causing a potentially fatal downstream blockage or stroke.
Volcano’s U.S. And E.U. Launch Of Valet® Microcatheter
Volcano Corp’s new device, called Valet is a high performance microcatheter that is used for guidewire support, wire exchange and contrast injections during complex coronary and peripheral interventional procedures and is particularly useful for highly stenosed lesions.
Acquisition Of Flexible Stenting Solutions Reinforces Cordis’ Endovascular Presence
J&J company Cordis Corporation, has announced it has completed the acquisition of Flexible Stenting Solutions, Inc., a leading developer of innovative flexible peripheral arterial, venous and biliary stents. Terms of the deal have not been disclosed at this time.
New Report Looks Into Global RDN Devices Crystal Ball
In short A new report, another on the subject of renal denervation(RDN), claims the world market for these devices is … continue reading “New Report Looks Into Global RDN Devices Crystal Ball”