Bard’s Lutonix DCB receives improved Medicare reimbursements
C.R. Bard (NYSE:BCR) said today that the U.S. Centers for Medicare and Medicaid Services has improved the payment for Bard’s Lutonix drug-coated balloon catheter through the Medicare hospital outpatient prospective payment system. The Murray Hill, N.J.-based company said that Medicare will now reimburse the full cost of its DCB device for percutaneous transluminal angioplasty, stenting, or atherectomy procedures. The new reimbursement determination is retroactive to April 1 this year, the company said. The Lutonix is the 1st FDA-approved DCB, Bard claims, and is used to treat patients with peripheral arterial disease...
Source: Mass Device - June 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Medicare C.R. Bard Centers for Medicare and Medicaid Services (CMS) Source Type: news

Boston Scientific And C. R. Bard Announce Distribution Agreement For Lutonix® Drug Coated Balloon
Boston Scientific Corporation (NYSE: BSX) and C. R. Bard, Inc. (NYSE: BCR) ("Bard") today announced that Boston Scientific will distribute the Lutonix® 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) in the United States under a limited distribution agreement reached with Bard. Terms of the agreement were not disclosed. (Source: Medical Design Online News)
Source: Medical Design Online News - February 10, 2015 Category: Medical Equipment Source Type: news

Consumer Information on: Medtronic IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter - P140010
The Medtronic IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Medtronic DCB) uses a drug-coated balloon to re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease (PAD). (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 20, 2015 Category: Medical Equipment Source Type: news

Covidien's Fortrex PTA Balloon Receives FDA 510(k) Clearance
Covidien plc recently announced U.S. Food and Drug Administration 510(k) clearance for its Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. (Source: Medical Design Online News)
Source: Medical Design Online News - December 1, 2014 Category: Medical Equipment Source Type: news

Medtronic's IN.PACT Drug-Coated Balloon Shows Safety and Efficacy for Peripheral Angioplasty in Diabetics
Data presented this morning at the VIVA 14 meeting in Las Vegas, Nevada, showed that patients treated with Medtronic's IN.PACT Admiral drug-coated balloon (DCB) for narrowings in their legs above-the-knee had significantly better outcomes than those treated with the standard "plain" balloon catheter, called percutaneous transluminal angioplasty (PTA). While these data were previously presented in April at the Charing Cross international symposium in London, today's session also showed that these positive findings for the DCB held true even for patients with diabetes, a population that typically presents with worse arterial...
Source: News from Angioplasty.Org - November 5, 2014 Category: Cardiology Source Type: news

Consumer Information on: Lutonix 035 Drug Coated Balloon PTA Catheter - P130024
The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) uses a drug-coated balloon to re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease (PAD). The balloon is coated on... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 29, 2014 Category: Medical Equipment Source Type: news

First Drug-Coated Balloon Approved By FDA For Leg Blockages
The FDA today announced that it had approved  for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - October 10, 2014 Category: Pharmaceuticals Authors: Larry Husten Source Type: news

FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease
The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD). (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 10, 2014 Category: American Health Source Type: news

TCT 2014: Medtronic's IN.PACT Admiral beats PTA in outcomes, costs
Medtronic unveils 1-year study results showing that its IN.PACT Admiral drug-coated balloon is clinically superior and more cost-effective than standard percutaneous transluminal angioplasty. Medtronic, TCT 2014News Well, Clinical Trials, Conference coverage, Minnesota, Peripheral Artery Disease, Transcatheter Cardiovascular Therapeutics symposium (TCT)read more (Source: Mass Device)
Source: Mass Device - September 16, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news

Medtronic Launches New Peripheral Angioplasty Catheter in Europe
Today Medtronic, Inc. (NYSE: MDT) announced the European launch of its latest product to address the problems of peripheral artery disease (PAD), the "TOTAL Across" crossing catheter, intended for use in the lower extremities, specifically those arterial blockages below the knee that often are the cause of critical limb ischemia. Today's announcement by Medtronic adds to their portfolio of peripheral devices, including the IN.PACT drug-eluting balloon, and several balloon catheters designed for use in challenging narrow below-the-knee blockages. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 13, 2014 Category: Cardiology Source Type: news

Medtronic Launches 'TOTAL Across' Crossing Catheter in Europe
New Peripheral Angioplasty Balloon Targets Challenging Lesions in Lower-Extremity, Including Below-the-Knee, Arteries Associated with Critical Limb Ischemia MINNEAPOLIS -- Feb. 13, 2014 --(Healthcare Sales & Marketing Network)-- Aligned with its commitm... Devices, Interventional, Product LaunchMedtronic, TOTAL across, crossing catheter, Angioplasty, Balloon catheter (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 13, 2014 Category: Pharmaceuticals Source Type: news

Medtronic's Drug-Eluting Balloon Data for Peripheral Angioplasty Submitted to FDA
Medtronic, Inc. (NYSE: MDT) announced on Thursday that it had submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon (DEB), to be used in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. Medtronic reports that with submission of this data, it is on track to gain FDA approval in two years, which would make it the first drug-eluting balloon available in the U.S. for use in the treatment of peripheral disease. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - August 19, 2013 Category: Cardiology Source Type: news