Vascular

Lombard Medical Technologies, plc has seen a first U.S. patient treated with its Aorfix™ endovascular stent graft for repair of an abdominal aortic aneurysm. Aorfix is the only endovascular stent graft with approved labeling for use in more challenging cases with neck angulations greater than 60 degrees.

St. Jude Medical, Inc., has gained CE Mark approval of its next-generation EnligHTN™ Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension. The company promises a time reduction from 24 minutes using its first device, to just 4 minutes.

Cardiovascular technology company Volcano Corporation has signed an agreement to acquire the Pioneer Plus™ diagnostic ultrasound transducer and percutaneous catheter from Medtronic, Inc. in a transaction that is expected to close by the end of August.

Reverse Medical Corporation has gained FDA clearance for US commercialization of its MVP™ Micro Vascular Plug system for peripheral artery embolization, and the first US clinical cases.

Abbott has expanded its global peripheral technology portfolio with the acquisition of IDEV Technologies, a privately held company focused on developing next-generation medical devices for use by interventional radiologists, vascular surgeons and interventional cardiologists.

So, five years after first getting a CE mark nod, Medtronic now has enough data to support its peripheral angioplasty balloon as far as module 1 of a PMA submission. Did EU regulatory authorities jump the gun too early or was the US hurdle too high for Invatec ’til Medtronic came along?

Boston Scientific has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of its Innova™ Self-expanding Stent System.

Following what it calls a “brief period of unavailability following a voluntary recall, Cook Medical is again shipping its Zilver® … continue reading “Cook Medical’s Zilver® PTX® Drug Stent Back in Circulation”

Cook Medical has completed patient enrollment in a study evaluating a technique for achieving vascular access via below-the-knee arteries. The new access technique could be used in treating peripheral arterial disease (PAD), including patients with critical limb ischemia.

Back in June Teleflex, Inc., saw its Arrow® GPSCath® Balloon Dilatation Catheter CE marked. Now the company tells us it has received U.S. FDA 510(k) clearance to market the devices in Higher Rated Burst Pressure (RBP) and 80 cm lengths.

University of Leuven in Belgium has become the first to use a new solution for end-stage renal disease hemodialysis patients. The HeRO Graft is indicated for catheter dependent ESRD patients on long-term hemodialysis who have exhausted all other access options, such as AV fistulas and grafts.

US device regulatory agency the FDA has issued a Class I recall, it’s highest category recall, for the LeMaitre Vascular Albograft Vascular graft, for the reason that it may leak from its surface following implantation. The same product was the subject of recall activity in Europe in March 2012, due to reports of profuse bleeding through the wall of the graft.

St. Jude Medical, Inc. has reported sales and net earnings for the second quarter ended June 29, 2013. Background We … continue reading “Mixed Bag for St.Jude Medical Sees Cardiac Rhythm Business Propped Up by The Rest”

Abbott has entered into an agreement to purchase IDEV Technologies, a privately held company focused on developing next-generation medical devices … continue reading “Abbott’s New Acquisition Signals Intent in Global Peripheral Artery Disease Market”

The Heli-FX Aortic Securement System sounds like it’s well on its way as endovascular repair company Aptus Endosystems, Inc., announces that its ANCHOR post-market registry enrollment has surpassed its key milestone of 250 patients.

Vascular device specialist AngioDynamics, has received FDA 510(k) clearance for the Xcela Plus Port family through its Navilyst company.