Bard touts 2-year data on Lutonix
C.R. Bard (NYSE:BCR) said that data from a 2-year study of its Lutonix drug-coated balloon catheter showed positive results for the device when compared to standard percutaneous transluminal angioplasty.
The 2-year Levant study data showed non-inferiority of the device and a trend towards superiority compared to standard PTA, the company said. Composite safety scores at 24 months were 78.7% for Lutonix, versus 70.9% for standard PTA.
Primary patency, or the rate of lesion reoccurrence, was at 58.6% with Lutonix vs 53% with standard PTA, the study reports. The difference shows a 10.5% relative increase for the Lutonix devic...
Source: Mass Device - June 19, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials C.R. Bard Lutonix Inc. Source Type: news
MassDevice.com +3 | The top 3 medtech stories for June 12, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Sorin, Cyberonics announce new slate for post-merger board
Sorin Group and Cyberonics announced a new slate for the board of directors that will oversee the company after the expected close of their $1.4 billion merger in the 3rd quarter.
Last month the companies announced the management roste...
Source: Mass Device - June 15, 2015 Category: Medical Equipment Authors: Melissa Annand Tags: News Well Source Type: news
Medtronic Initiates U.S. Launch of Fortrex™ PTA Balloon
Medtronic plc (NYSE: MDT) announced today the launch of the Fortrex™ over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. The Fortrex PTA balloon catheter utilizes a high pressure balloon to break up the blockages and open the vessels to help maintain arteriovenous (AV) access in the peripheral vascular system. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 14, 2015 Category: Cardiology Source Type: news
Medtronic launches Fortrex PTA balloon catheter in US
Medtronic (NYSE:MDT) said yesterday that it launched its Fortrex percutaneous transluminal angioplasty balloon catheter in the U.S.
The Fortrex is designed to treat peripheral artery disease and maintain arteriovenous access for hemodialysis, the Fridley, Minn.-based company said. The catheter uses a balloon to break up plaque blockages in the peripheral vascular system, or blockages in hemodialysis patients at the dialysis sites, the company added.
“Being able to maintain AV access for patients receiving hemodialysis for renal disease and kidney failure is critical as it is a patient’s lifeline. In the past, ...
Source: Mass Device - June 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters medtronic Source Type: news
MassDevice.com +3 | The top 3 medtech stories for June 10, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Battelle pairs with Feinstein Institute to develop ‘neural tourniquet’
Battelle said that it’s partnering with the Feinstein Institute to develop a novel “neural tourniquet” designed to staunch blood loss using neurostimulation.
The device functions by electrical...
Source: Mass Device - June 10, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
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
Medtronic Drug-Coated Balloon for Treatment of Peripheral Arterial Disease Shows Strong Results in Long Lesions
Presented for the first time today at EuroPCR during the "Hot line" session on "Peripheral interventions," new clinical data from two different studies show that the IN.PACT Admiral drug-coated balloon from Medtronic plc (NYSE: MDT) successfully treated long lesions in the superficial femoral and popliteal arteries. Prof. Dierk Scheinert, chairman of the division for interventional angiology at University-Hospital Leipzig in Germany, presented 12-month results for 157 patients enrolled in the IN.PACT Global Study's long lesion imaging cohort. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 3, 2015 Category: Cardiology Source Type: news
Contego Medical raises $6m for embolic filter tech
Contego Medical raises nearly $6 million in a Series B round it plans to use to expand its roster and develop its embolic protection balloon and stent-delivery systems.
Contego Medical said it pulled in $5.6 million in a Series B round to advance its embolic protection technology for angioplasty balloon and stent-delivery catheters.
Contego Medical, Hatteras Venture Partners, Lookout Capital, Medical Mutual, Mountain Group PartnersNews Well, Cardiovascular, Funding Roundup, Strokeread more (Source: Mass Device)
Source: Mass Device - April 27, 2015 Category: Medical Equipment Authors: Mark Hollmer Source Type: news
FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures
The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures, such as balloon angioplasty and stenting, which re-open coronary arteries that are narrowed or blocked due to severe coronary artery disease (CAD). (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 23, 2015 Category: American Health Source Type: news
Heart bypass surgery outperforms new generation stents
Despite the advent of a new generation of stents, patients with multiple narrowed arteries in the heart who received coronary artery bypass grafting fared better than those whose arteries were opened with balloon angioplasty and stents in a recent study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - March 16, 2015 Category: Science Source Type: news
Heart bypass surgery outperforms new generation stents
(American College of Cardiology) Despite the advent of a new generation of stents, patients with multiple narrowed arteries in the heart who received coronary artery bypass grafting fared better than those whose arteries were opened with balloon angioplasty and stents in a study presented at the American College of Cardiology's 64th Annual Scientific Session. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 16, 2015 Category: Global & Universal Source Type: news
CMS Approves Pass-Through Payment for Lutonix DCB for Outpatient Use
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved a pass-through payment for C. R. Bard's Lutonix® drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favorable recommendation from the FDA's Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 26, 2015 Category: Cardiology Source Type: news
Medicare Approves Transitional Pass-Through Payment for Outpatient Use of Medtronic Drug-Coated Balloon
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved a transitional pass-through payment for Medtronic's IN.PACT Admiral drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system (OPPS), removing a potential barrier to patient access to this new medical device, which represents a significant improvement to the standard of care for peripheral arterial disease in the upper leg. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 26, 2015 Category: Cardiology Source Type: news
Medtronic Gains CE Mark for Euphora Semicompliant Coronary Balloon; Launches in Europe
Today Medtronic plc (NYSE: MDT) announced that its Euphora™ Semicompliant Balloon Dilatation Catheter has received the CE (Conformité Européene) mark and that the product has been launched, the first case being performed by Dr. Richard Edwards in the UK. While most think of stents when they think of interventional cardiology, balloons play an important role in percutaneous coronary interventions (PCI). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 17, 2015 Category: Cardiology Source Type: news
Boston Scientific to Distribute Bard's Lutonix Drug-Coated Balloon for Blockages in Leg Arteries
Boston Scientific (NYSE: BSX) and C. R. Bard, Inc. (NYSE: BCR) have announced that Bard's Lutonix® 035 drug-coated balloon will be distributed in the United States by Boston Scientific. The specific terms of the agreement were not disclosed. The Lutonix was the first drug-coated balloon (DCB) approved by the FDA for use in the superficial femoral or popliteal arteries in the leg. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 10, 2015 Category: Cardiology Source Type: news
