News

drug-eluting balloons, DEB, ECRI, report, peripheral artery disease, PAD, cath

ECRI Institute has created a report that offers an overview of drug-eluting balloon (DEB) technology, “Health Technology Forecast report, "Drug-eluting Angioplasty Balloons for...

Balloon catheters, Heart Valve repair, Cath Lab, Hybrid OR

Maquet Medical Systems USA announced an agreement to serve as the exclusive U.S. distributor of InterValve Inc.'s V8 Aortic Valvuloplasty Balloon Catheter.

Balloon catheters, cath lab, peripheral artery disease (PAD), Lithoplasty

Lithoplasty is a balloon-based technology that utilizes integrated lithotripsy to disrupt both superficial and deep calcium and normalize vessel wall compliance prior to low-pressure balloon...

Covidien announced it has received CE Mark approval for its Stellarex drug-coated angioplasty balloon (DCB). 

Medtronic, In.Pact, Admiral drug-coated balloon, DCB, drug-eluting balloon

The U.S. Food and Drug Administration (FDA) has cleared Medtronic’s In.Pact Admiral drug-coated balloon (DCB) for the interventional treatment of peripheral artery disease (PAD) for the...

balloon catheters, clinical trial/study, medtronic, IN.PACT Admiral drug-coated

The results of a landmark study published this month in Circulation indicate that a device from Medtronic Inc. called the IN.PACT Admiral drug-coated balloon (DCB) significantly...

Cardionovum GmbH announced that it has initiated a 150-patient clinical study of its novel paclitaxel-releasing, high-pressure shunt balloon dilatation catheter, Aperto.

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.

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...

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...

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.