News

Balloon catheter, interventional radiology, FDA clearance, kidney disease

Covidien announced that it received U.S. Food and Drug Administration 510(k) clearance for its Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter.

Covidien releases 12-month results of the DEFINITIVE AR study, the first randomized study designed to identify the clinical benefits of plaque removal using directional atherectomy ...

Optimizing the treatment of coronary artery disease with a new foundation for future stent innovations, Medtronic Inc. announces CE mark and international launch of the Resolute Onyx ...

TriReme, PTA Chocolate Balloon, valvuloplasty, heart valve repair

Catalist-listed QT Vascular Ltd. has acquired a novel technology platform called Java, and all associated intellectual property, which was developed independently in Israel.

Shockwave, lithoplasty, lithotripsy

Shockwave Medical announced positive clinical results from Disrupt PAD, a single-arm multicenter study evaluating the safety and utility of Lithoplasty balloon catheters for the treatment of...

For the treatment of peripheral artery disease in leg arteries above the knee, the IN.PACT Admiral ...

Shockwave Medical announced that the company will present clinical results from DISRUPT PAD, a single-arm multicenter study evaluating the safety and utility of Lithoplasty balloon catheters for...

Metro Health (Michigan) cardiovascular specialist Jihad Mustapha, M.D., is one of the first physicians in the United States to use a new medical device to treat peripheral artery disease (PAD).

Restenosis, the recurrence of narrowing of the arteries after stenting, is a common risk of this endovascular treatment. There are no well-defined guidelines to treat restenosis, but recent...

Medtronic IN.PACT Admiral Drug Coated Balloon Peripheral Artery Disease Treatmen

Presented for the first time at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB)...

FDA Clears Lutonix 035 Drug Coated Balloon C.R. Bard Inc.

C. R. Bard Inc. announced the U.S. Food and Drug Administration (FDA) approval of the Lutonix 035 drug-coated balloon (DCB) catheter for percutaneous transluminal angioplasty (PTA) after pre-...

A new clinical trial comparing the use of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in treating in-stent restenosis (ISR) from drug-eluting stents found that EES provided...

September 11, 2014 — Medtronic announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the NC Euphora noncompliant balloon dilatation catheter. The new device will be...

Teleflex Inc.’s subsidiary Hotspur Technologies Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the Arrow GPSCath Balloon Dilatation Catheters designed for use...

Boston Scientific Corp. CE mark Ranger Ranger Paclitaxel-coated PTA Balloon Cath

Boston Scientific received CE mark for the Ranger Paclitaxel-coated PTA Balloon Catheter. The technology is now in full European market launch. 

agent, boston scientific, balloon catheter

The Agent Drug-Coated Balloon (DCB) provides physicians with an additional alternative to treat both in-stent restenosis (ISR) and de novo small vessel coronary disease.

July 11, 2014 — Cordis Corp. announced the launch of its Saber PTA (percutaneous transluminal angioplasty) dilatation catheter for the treatment of patients with peripheral arterial disease (PAD...

FDA Recommendation Lutonix Drug Coated Balloon Catheter

C. R. Bard Inc. announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix...

Medtronic Inc. announced CE mark and launch of the NC Euphora noncompliant balloon dilatation catheter. 

May 23, 2014 — The first drug-eluting balloon to go up for review by the U.S. Food and Drug Administration (FDA) will be discussed at the next Circulatory System Devices Panel of the Medical...