Vascular

On May 13, 2013, Endologix, Inc. initiated a recall of AFX Introducer System Model S17-45 due to reports of the dilator breaking during procedures. Now this recall has been elevated to FDA Class I status.

California-based Reverse Medical Corporation has announced the initial clinical use of its MVP™ Micro Vascular Plug system for peripheral artery embolization. … continue reading “CE Mark And Clinical Use For MVP™ Micro Vascular Plug In Peripheral Embolization”

J&J Company, Cordis Corporation has received FDA clearance of its latest innovation in guiding catheters: the ADROIT™ 6F Guiding Catheter, which the company says means easier advancement of devices, with its 0.072′ diameter, the largest inner diameter of any guiding catheter in the U.S. .

Tissue processing and device company CryoLife, Inc.,has gained a CE Mark for its new iteration HeRO (Hemodialysis Reliable Outflow) Graft … continue reading “CE Mark For CryoLife’s New HeRo® Graft”

Cardiovascular Systems, Inc. unveiled new data from its CONFIRM study series in three poster presentations at the 2013 New Cardiovascular … continue reading “New Data Supports Orbital Atherectomy For PAD In “Real World” Population”

Peripheral Vascular Disease therapies include the use of percutaneous transluminal angioplasty(PTA) using a balloon catheter. While recent news has been all about the race to (U.S.) market for drug eluting varieties, Medtronic is no doubt hoping its Pacific Plus device is sufficiently feature-packed to take a chunk of the market until their drug eluter gains approval.

St. Jude Medical, Inc. has gained U.S. FDA approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

To date, there are no drug-coated balloons indicated in the US for peripheral arterial intervention, despite their successful adoption and growing clinical pedigree in Europe. A new study might just see C R Bard’s Lutonix drug balloon over the line first.

Medtronic, Inc. is trumpeting with new data on its Endurant AAA stent graft, which it says demonstrates durable clinical performance through three years of patient follow-up in the endovascular repair of Abdominal Aortic Aneurysms.

Medtronic, Inc. tells us that that enough patients have been enrolled in its clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company’s U.S. regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.

Seemingly hardly off our pages in recent weeks, Biosensors International Group, Ltd., cardio device company has entered into a licensing … continue reading “Biosensors Steps Into Drug Eluting Balloon Markets With Eurocor OEM Deal”

Medtronic, Inc. is showcasing its newly approved stent graft at this weekend’s Vascular Annual Meeting, taking place in San Francisco. The company has gained FDA approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA 510(k) clearance for the Sentrant Introducer Sheath

The FDA has issued a Class I recall for the Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent. All sizes, diameters and lot numbers manufactured prior to April 16 2013 are implicated.

Another one of the renal denervation big boys sees data presented which confirms sustainable blood pressure reduction. This time its Boston Scientific, seeing clinical results using its recently acquired Vessix balloon-based system.

Medtronic, Inc. has announced it has finished randomizing Symplicity HTN-3, the company’s pivotal U.S. clinical trial of the Symplicity™ renal denervation system for treatment-resistant hypertension. The company is hoping this is a landmark in its progress towards U.S. approval.

St.Jude’s says its new EnligHTN system offers simultaneous ablations with an intuitive touch screen generator, potentially enabling faster procedure times for the treatment of hypertension. A new study aims to back the claims.