Spectranetics wins 510(k) clearance for laser atherectomy cath
Spectranetics (NSDQ:SPNC) said yesterday it won FDA 510(k) clearance for its next-generation Turbo-Power laser atherectomy catheter for treating in-stent restenosis. The Turbo-Power laser catheter treats at the tip and debulks lesions in a single step with remote automatic rotation for accurate directional control, the Colorado Springs, Colo.-based company said. “Patients with ISR present the most challenging real-world cases, with the longest, toughest lesions, among those suffering with peripheral arterial disease. Turbo-Power, with its eccentric tip design, allows far more effective debulking of ISR lesions and I ...
Source: Mass Device - November 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Catheters Regulatory/Compliance Vascular Spectranetics Corp. Source Type: news

VIVA 2015 Roundup: Medtronic touts Valiant stent graft, PAD stent-treatment data
Medtronic (NYSE:MDT) this week presented data from 2 studies of its stent systems and announced a new study of its In.Pact Admiral drug-coated balloon. The announcements were made at the VIVA physicians annual conference in Las Vegas, Nev. The Fridley, Minn.-based medical giant presented data from a 2-year clinical trial of its Valian Captivia thoracic stent graft system for treating type B aortic dissections, reporting safety and efficacy at 2-years. Data from the 2-year follow up of the 35-patient FDA approved IDE trial reported no post-index procedure ruptures or conversions, device related adverse events or&n...
Source: Mass Device - November 7, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Abbott Avinger Boston Scientific C.R. Bard Cook Medical Medtronic Spectranetics Corp. TriVascular TVA Medical Vascular Dynamics Vascular Interventional Advances (VIVA) Source Type: news

Medtronic touts In.Pact Admiral DCB data
Medtronic (NYSE:MDT) today touted data from a pair of studies of its In.Pact Admiral drug-coated balloon, presented today at the annual Vascular Interventional Advances conference in Las Vegas. Researchers revealed the formal cost-effectiveness analysis of the U.S. cohort of Medtronic’s In.Pact SFA trial, and in-stent restenosis cohort data from its In.Pact Global study. Medtronic said the 2-year, prospective cost-effectiveness study of 181 patients showed that, although treatment with the drug-coated balloon was more expensive than with standard percutaneous transluminal angioplasty, costs were actual...
Source: Mass Device - November 2, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Drug-Eluting Balloons Medtronic Peripheral Artery Disease Vascular Interventional Advances (VIVA) Source Type: news

AV Medical wins FDA 510(k) for Chameleon balloon catheter
Israel based AV Medical said today it won FDA 510(k) clearance for its Chameleon angioplasty balloon catheter. The company’s Chameleon catheter comes equipped with proximal injection port technology which the company claims make it the 1st and only angioplasty balloon catheter that allows for simultaneous balloon inflation and injection of intravascular fluids during guidewire access. “Our entire team is thrilled with this news. Chameleon represents the first product to include our proprietary Proximal Injection Port design. We look forward to bringing Chameleon to the dialysis access market in the United State...
Source: Mass Device - October 26, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Vascular AV Medical Source Type: news

Medtronic Touts Drug-Coated Balloon Clinical Data
Medtronic plc has announced that new two-year clinical data from the pivotal IN.PACT SFA Trial revealed that the IN.PACTAdmiraldrug-coated balloon (DCB) continues to provide superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries or SFA) and behind the knee (popliteal arteries). (Source: Medical Design Online News)
Source: Medical Design Online News - October 15, 2015 Category: Medical Equipment Source Type: news

TCT 2015: Two-year results from Medtronic’s In.Pact SFA trial
Two-year results from Medtronic‘s (NYSE:MDT) In.Pact SFA study showed that  the drug-eluting balloon was better than conventional balloon angioplasty, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. The 331-patient study randomized subjects 2:1 to either treatment with Medtronic’s In.Pact Admiral DEB or standard angioplasty. The primary efficacy endpoint was primary patency, while the primary safety endpoint was a composite of freedom from device- and procedure-related death after 30 days and freedom from target limb major amputation and clin...
Source: Mass Device - October 14, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Drug-Eluting Balloons Medtronic TCT 2015 Source Type: news

Tryton Medical touts side branch stent study data
Tryton Medical said yesterday that data from a post hoc analysis of a randomized clinical trial of its Tryton side branch stent for patients with coronary bifurcation lesions showed reductions in target vessel failure and improved side branch diameter. Results from the study were published in the journal Catheterization and Cardiovascular Interventions. The 289-patient post-hoc analysis focused on patients with side branch bifurcation lesions 2.25 mm in diameter or greater. The study reported that target vessel failure was lower in the Tryton-treated group compared to the control, and that patients treated with the co...
Source: Mass Device - October 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Stents Tryton Medical Inc. Source Type: news

PAD: Intact Vascular wins IDE for Tack endo repair
Intact Vascular said today it won FDA Investigative Device Exemption for a clinical trial of its Tack endovascular system for patients with peripheral arterial disease undergoing percutaneous angioplasty. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, Wayne, Penn.-based Intact Vascular said. “The earlier Toba experience demonstrates that the long term results from angioplasty can be substantially improved if we repair arterial dis...
Source: Mass Device - September 30, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Food & Drug Administration (FDA) Vascular Intact Vascular Peripheral Artery Disease Source Type: news

Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015: Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31 Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 9...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

MassDevice.com +3 | The top 3 medtech stories for August 3, 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. CR Bard’s Lutonix wins Medicare reimbursement add-on C.R. Bard said that angioplasty treatments with its Lutonix drug-coated balloon will now be eligible for add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payme...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

CR Bard’s Lutonix wins Medicare reimbursement add-on
C.R. Bard (NYSE:BCR) said today that angioplasty treatments with its Lutonix drug-coated balloon will now be eligible for add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payment systems. The add-on payment, with a maximum of $1,036, will help cover additional costs for treating patients with the Lutonix during inpatient settings and is slated to go into effect October 1, C.R. Bard said. “After providing reimbursement in the outpatient setting earlier this year, CMS has now provided additional reimbursement for the Lutonix DCB in th...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Food & Drug Administration (FDA) Medicare Vascular C.R. Bard Centers for Medicare and Medicaid Services (CMS) Source Type: news

Bard, Medtronic win Medicare reimbursement add-on for DCBs
Medtronic (NYSE:MDT) and C.R. Bard (NYSE:BCR) said today that angioplasty treatments with  drug-coated balloons will now be eligible for new technology add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payment systems. The add-on payment, with a maximum of $1,036, will help cover additional costs for treating patients for peripheral artery disease with Bard’s Lutonix and Medtronic’s In.Pact Admiral drug-coated balloon during inpatient settings.  The new coverage is slated to go into effect October 1. &l...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Food & Drug Administration (FDA) Medicare Vascular C.R. Bard Centers for Medicare and Medicaid Services (CMS) Source Type: news

Case series: anxiety and agitation following exposure to the synthetic cannabinoid ADB-PINACA
3 out of 5 stars A Common Source Outbreak of Severe Delirium Associated with Exposure to the Novel Synthetic Cannabinoid ADB-PINACA. Schwartz MD et al. J Emerg Med 2015 May;48:573-80. Abstract As noted in a recent survey of synthetic cannabinoid exposures in the New England Journal of Medicine, the synthetic cannabinoid (SC) ADB-PINACA was associated with outbreaks in August and September 2013, both in Brunswick GA (22 cases) and Denver CO (> 220 exposures). This paper reports on 7 cases from the outbreak in Georgia. All patients tested positive for ADB-PINACA or its metabolic ADB-PINACA-5-...
Source: The Poison Review - July 29, 2015 Category: Toxicology Authors: Leon Tags: Medical ADB-PINACA agitation anxiety black mamba case series crazy clown delirium synthetic cannabinoid Source Type: news

Another stent better than DEB, DCB for in-stent restenosis, studies find
Treatment with another stent, rather than from a drug-coated or drug-eluting balloon, has been shown to be more effective in treating coronary in-stent restenosis, according to 2 new studies. The 2 studies, 1 European and 1 Japanese, were published in the Journal of the American College of Cardiology earlier this month. The 309-patient European Ribs IV clinical trial looked at patients with drug-eluting stent in-stent restenosis, comparing the efficacy of retreatment with drug-eluting balloons and everolimus-eluting stents. Results from the study indicated that patients treated with EES showed an 8% lower rate of cardiac d...
Source: Mass Device - July 15, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Drug-Eluting Stents Journal of the American College of Cardiology Source Type: news

Bard touts publication of Lutonix study in NEJM
C.R. Bard (NYSE:BCR) said last Thursday that a 2-year study of its Lutonix drug-coated balloon catheter was published in The New England Journal of Medicine. The 2-year Levant 2 study data showed non-inferiority of the device and a trend towards superiority, compared to standard percutaneous transluminal angioplasty, in the treatment of peripheral artery disease, the company said. “We want to thank the investigators involved in the Levant 2 trial for their authorship of this ground-breaking study. Publication of the study results in The New England Journal of Medicine demonstrates the hi...
Source: Mass Device - June 29, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular C.R. Bard New England Journal of Medicine Source Type: news

Bard's Drug-Coated Angioplasty Balloon Continues to Show Efficacy
(Source: MDDI)
Source: MDDI - June 25, 2015 Category: Medical Equipment Authors: Arundhati Parmar Tags: Implantable Devices Source Type: news

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 pa...
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 electricall...
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

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

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

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

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

Medtronic Launches Drug-Coated Balloon for Peripheral Artery Disease in U.S.
Medtronic plc (NYSE: MDT) announced yesterday that its IN.PACT Admiral drug-coated balloon (DCB), approved last month by the FDA, is now available for use in the U.S. The first uses of this new addition to the interventional armamentarium were in New York, Michigan, Arizona, and Louisiana. The IN.PACT Admiral is the second such device approved by the FDA, the first being Bard's Lutonix back in October. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 6, 2015 Category: Cardiology Source Type: news

Spectranetics Completes Acquisition of Stellarex(TM) Drug Coated Balloon Assets From Covidien
COLORADO SPRINGS, Colo., Jan. 27, 2015 -- (Healthcare Sales & Marketing Network) -- The Spectranetics Corporation (SPNC) today announced it has completed the acquisition of Covidien's Stellarex(TM) drug coated balloon angioplasty (DCB) platform. The transa... Devices, Interventional, AcquisitionsSpectranetics, Covidien, Stellarex, drug coated balloon (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 27, 2015 Category: Pharmaceuticals 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 Stellarex Drug-Coated Angioplasty Balloon Receives CE Mark To Treat Peripheral Arterial Disease Patients
Covidien plc recently announced it has received CE Mark approval for its Stellarex drug-coated angioplasty balloon (DCB). (Source: Medical Design Online News)
Source: Medical Design Online News - January 12, 2015 Category: Medical Equipment Source Type: news

FDA Approves Medtronic Drug-Coated Balloon for Treating Peripheral Artery Disease in the Upper Leg
Medtronic, Inc. (NYSE: MDT) has announced that the FDA has approved its drug-coated balloon (DCB), the IN.PACT Admiral, for the treatment of peripheral artery disease (PAD) in the upper leg. The IN.PACT Admiral is the second such device approved by the FDA, the first being Bard's Lutonix back in October. The FDA approval of the IN.PACT was supported by a body of clinical evidence of 21 studies involving more than 3,500 patients worldwide, demonstrating the best clinical outcomes of any medical technology for the treatment of PAD in the SFA and popliteal arteries. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 7, 2015 Category: Cardiology Source Type: news

Medtronic Drug-Coated Balloon for Peripheral Artery Disease Tops Standard Balloon Angioplasty in Landmark Study
The results of a landmark study published this month in Circulation, the world's leading cardiovascular journal, indicate that a novel medical device from Medtronic, Inc. (NYSE: MDT) called the IN.PACT Admiral drug-coated balloon (DCB) significantly outperformed standard balloon angioplasty in the treatment of symptomatic peripheral artery disease in the upper leg -- specifically, the superficial femoral and proximal popliteal arteries. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 7, 2015 Category: Cardiology Source Type: news

Study: Medtronic's In.Pact Admiral balloon beats standard angioplasty
Medtronic touts a new study showing that its In.Pact Admiral drug-eluting balloon performed better than a standard angioplasty balloon in the treatment of symptomatic peripheral artery disease of the upper leg. Medtronic, American Heart Assn.News Well, Clinical Trials, Peripheral Artery Diseaseread more (Source: Mass Device)
Source: Mass Device - December 23, 2014 Category: Medical Equipment Authors: Val Kennedy 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 Acquisition of Covidien Receives U.S. FTC Clearance
Medtronic, Inc. (NYSE: MDT) and Covidien plc (NYSE: COV) today announced the receipt of U.S. Federal Trade Commission (FTC) clearance of Medtronic's proposed acquisition of Covidien. The FTC's clearance follows Medtronic's and Covidien's agreement to a proposed consent order, which includes a commitment to divest certain assets related to Covidien's drug-coated balloon catheter product. Medtronic's acquisition of Covidien is expected to close in early 2015 after receipt of certain additional regulatory clearances and approvals by both companies' shareholders and sanction by the High Court of Ireland. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 27, 2014 Category: Cardiology Source Type: news

Atherectomy and balloon angioplasty beat angioplasty alone in Covidien trial
Atherectomy and balloon angioplasty proves more effective than angioplasty alone in treating peripheral artery disease, according to new data from a Covidien study. CovidienNews Well, Clinical Trials, Peripheral Artery Diseaseread more (Source: Mass Device)
Source: Mass Device - November 6, 2014 Category: Medical Equipment Authors: Val Kennedy Source Type: news

5-Year Data for Zilver PTX Drug-Eluting Stent for Leg Arteries Show Continued Efficacy
Following up on the presentation of 4-year data for the Zilver PTX drug-eluting stent at last year's VIVA meeting, Cook Medical today announced the 5-year outcomes - and the results show that patients arteries have remained open, and that there has been no "late catch-up" with the Zilver. While patency was slightly lower at the 5-year mark than at 4-years for both the Zilver and standard balloon due to disease progression and other causes, the divergence between the two therapies actually grew from year 4 to 5, favoring the Zilver. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 5, 2014 Category: Cardiology 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 wors...
Source: News from Angioplasty.Org - November 5, 2014 Category: Cardiology Source Type: news

Medtronic's In.Pact Admiral balloon bests angioplasty in diabetics
Medtronic's In.Pact Admiral drug-eluting balloon bested angioplasty in treating diabetic peripheral artery disease patients, according to 1-year data from the In.Pact SFA trial. MedtronicNews Well, Clinical Trials, Peripheral Artery Diseaseread more (Source: Mass Device)
Source: Mass Device - November 4, 2014 Category: Medical Equipment Authors: Brad Perriello 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

FDA Approves First Drug Eluting Angioplasty Balloon
The FDA has approved C.R. Bard’s Lutonix 035 Drug Coated Balloon (Lutonix DCB), a technology that may reduce restenosis of vessels treated by balloon angioplasty. This technology is the first of its kind to be approved for use in the femoral and popliteal arteries when they are stricken by Peripheral Artery Disease (PAD). (Source: Medical Design Online News)
Source: Medical Design Online News - October 16, 2014 Category: Medical Equipment Source Type: news

FDA Approves World's First Drug-Coated Angioplasty Balloon Catheter
(Source: MDDI)
Source: MDDI - October 14, 2014 Category: Medical Equipment Authors: Arundhati Parmar Tags: Implantable Devices Source Type: news

First Drug-Coated Balloon Approved by FDA for Leg Blockages (FREE)
By Larry Husten Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD The FDA has approved the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the superficial femoral and popliteal arteries. The … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - October 14, 2014 Category: Primary Care Source Type: news

FDA Approves Lutonix 035: First Drug-Coated Balloon for Blockages in Leg Arteries
The U.S. FDA has approved the first drug-coated balloon for use in opening up blockages in the peripheral arteries, specifically the superficial femoral or popliteal arteries in the leg. The Lutonix 035 was approved in Europe in 2012 but has taken an additional two years for the FDA to give it the go-ahead. An FDA panel unanimously recommended approval back in June, although there were questions regarding the results that showed no additional benefit in women above the therapy of a standard non-coated balloon. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 13, 2014 Category: Cardiology Source Type: news