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Surmodics Announces Global Approvals of .014 & #226; �? Low-Profile PTA Balloon Dilation Catheter
The company received FDA 510(k) and CE Mark clearance EDEN PRAIRIE, Minn. - Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for peripheral angioplasty procedures. The company is making this product...This story is related to the following:Catheters (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - September 19, 2017 Category: Medical Devices Source Type: news

Contego Medical wins CE Mark for Vanguard IEP angioplasty system
Contego Medical said today it won CE Mark approval in the European Union for its Vanguard IEP periperhal balloon angioplasty system and launched the device in the region. The newly cleared Vanguard IEP system incorporates a peripheral angioplasty balloon and distal embolic filter on a single catheter, the Raleigh, N.C.-based company said. The system has an over-the-wire design with a sheathless integrated 150-micron pore filter distal for the angioplasty balloon. “The Vanguard IEP System is an important step toward enhancing safety for patients undergoing peripheral angioplasty for occlusive disease. This device...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Regulatory/Compliance Vascular Contego Medical Source Type: news

Medtronic Launches Below-The-Knee Clinical Study in Europe for Treatment of PAD Using New Drug-Coated Balloon Technology
This study will evaluate the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This is an investigational device, which uses Medtronic's unique IN.PACT ™ Admiral™ drug coating technology. The study will enroll approximately 60 patients at four sites in Europe. The primary endpoint is late lumen loss at nine months. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 9, 2017 Category: Cardiology Source Type: news

Medtronic launches DCB clinical trial for below-the-knee peripheral artery disease
Medtronic (NYSE:MDT) said today that it launched a clinical trial to evaluate the use of its In.Pact paclitaxel-coated percutaneous transluminal angioplasty balloon catheter in patients with below-the-knee peripheral arterial disease. The company treated its 1st patient in the In.Pact BTK study, performing the procedure on a patient with critical limb ischemia. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic launches DCB clinical trial for below-the-knee peripheral artery disease appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 9, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Vascular Medtronic Source Type: news

AV Medical wins expanded FDA 510(k) for Chameleon PTA balloon cath
AV Medical Technologies said today it won expanded FDA 510(k) clearance for its Chameleon PTA balloon catheter designed for the infusion of diagnostic or therapeutic fluids. The Chameleon is designed to allow operators to inject diagnostic or therapeutic fluids through the catheter during procedures, whether the balloon is inflated or deflated and while maintaining wire position, the Israel-based company said. “The Chameleon balloon offers advantages for experienced operators as well as those training in dialysis access procedures. We appreciate the efficiency that it provides to these cases as well as the peace of m...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance AV Medical Source Type: news

Intact Vascular launches BTK balloon angioplasty trial of its Tack endovascular system
Intact Vascular said today it launched the Toba II BTK clinical trial to evaluate the safety and efficacy of its Tack endovascular system along with standard balloon angioplasty for treating critical limb ischemia in the popliteal and tibial arteries. The Wayne, Penn.-based company said it enrolled the 1st patient in the trial at Yuma, Ariz.’s Yuma Regional Hospital and Heart, Lung and Vascular Center. The 1st patient in the trial was treated by Dr. Joseph Cardenas. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physician...
Source: Mass Device - February 13, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blog Intact Vascular Source Type: news

First Drug-Coated Balloon (DCB) Study Results in Japan Demonstrate Consistent Clinical Outcomes with Other Medtronic DCB Studies
The IN.PACT SFA Japan Trial enrolled 100 patients at 11 sites in Japan who were randomized to treatment with either the DCB (n=68) or plain balloon angioplasty (percutaneous transluminal angioplasty, or PTA) (n=32). Per protocol, primary patency rates were assessed at 12 months of follow-up and demonstrated: 89.2 percent for the DCB group and 48.4 percent for the PTA group (p (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 9, 2017 Category: Cardiology Source Type: news

Intact Vascular wins CE Mark for Tack blood vessel repair device
Intact Vascular said today that it won CE Mark approval in the European Union for its Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty below the knee. The indication extends the system’s use in the EU to the tibial arteries between the knee and the ankle. The Tack implant can be used in arteries ranging from 1.5 mm to 4.5 mm in diameter and unlike stents, it adapts to the diameter of the artery, according to Wayne, Penn.-based Intact Vascular. The CE Mark was supported by data from the company’s TOBA BTK clinical trial, which examined the us...
Source: Mass Device - January 17, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Regulatory/Clearance Vascular Wall Street Beat Intact Vascular Source Type: news

Spectranetics wins CE Mark for smaller Stellarex DCB
Spectranetics (NSDQ:SPNC) said yesterday that it won CE Mark approval in the European Union for a smaller size of its Stellarex drug-coated balloon. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia. The larger, 0.035” device won CE Mark approval in December 2014, just before Spectranetics paid Covidien $30 million deal for the angioplasty platform following the consummation of Medtronic‘s (NYSE:MDT) $50 billion merger with Covidien. The Colorado Springs-based company filed for pre-market approva...
Source: Mass Device - November 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Regulatory/Compliance Vascular Drug-Eluting Balloons Peripheral Artery Disease Spectranetics Corp. Source Type: news

TCT 2016: Structural heart, drug-coated balloons take their turn on Day 3
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016. After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2. Day 3 saw a wider variety of topics, featuring big-name devices for structural heart repair and peripheral artery disease at the Transcatheter Cardiovascular Therap...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Balloons TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news

Gore touts 1-year data from Japanese study of Viabahn stent graft
W.L. Gore & Associates yesterday released 1-year data from a Japanese study of its Viabahn stent graft, touting a nearly 90% primary patency rate at 12 months. Data comes from a 103-patient single-arm study which enrolled a “challenging patient population” with lesions greater than 10cm, Newark, Del.-based Gore said. “Eighty-eight percent is an extremely high primary patency for these long complex lesions with an average length of 22 cm, especially given the scrutiny of the study design: a prospective, multicenter IDE clinical study that was core lab adjudicated and reviewed by the Japanese regulatory...
Source: Mass Device - September 21, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular W.L. Gore & Associates Source Type: news

FDA approves Medtronic ’ s In.Pact Admiral DCB for in-stent restenosis
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients. The Fridley, Minn.-based medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study comparing the DCB treatment with standard percutaneous balloon angioplasty. “Prior to the FDA approval of In.Pact Admiral DCB for ISR, physicians were challenged to find a durable treatment for PAD patients, consideri...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Medtronic Peripheral Artery Disease Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 11, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters.   5. GI Dynamics looks to next year for 2nd bite at FDA apple for EndoBarrier GI Dynamics is hoping to make another run at FDA approval for its flagship EndoBarrier treatment for obesity and diabetes after its 1st try failed last ye...
Source: Mass Device - August 11, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Spectranetics releases final 1-year results for Stellarex drug-coated balloon
Spectranetics (NSDQ:SPNC) today released the final 1-year results from the Illumenate EU RCT study comparing treatment with its Stellarex drug-coated balloon to percutaneous transluminal angioplasty, touting a 24% higher rate of primary patency with the DCB. One-year results from the 328-patient trial were presented at the Amputation Prevention Symposium in Chicago this week. “The Stellarex DCB produced outstanding results in this rigorous trial, validating its earlier first-in-human and interim Illumenate global studies. These consistent, high quality outcomes are achieved with a low dose drug balloon, making this d...
Source: Mass Device - August 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Spectranetics Corp. Source Type: news

FDA approves longer version of Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that the FDA approved a longer version of its In.Pact Admiral drug-coated balloon for treating peripheral artery disease. The 150mm-lenth device is available in 4mm, 5mm and 6mm diameters, the Fridley, Minn.-based company said. The FDA originally cleared the In.Pact Admiral DCB in January 2015, about 6 years after it won CE Mark approval in the European Union. “The expansion of In.Pact Admiral DCB to 150mm lengths demonstrates our commitment to providing meaningful technology to improve patient outcomes in a value-based healthcare environment,” peripheral unit general manager&nbs...
Source: Mass Device - July 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Peripheral Artery Disease Source Type: news

Getinge wins expanded FDA clearance for Sterizone VP4
Getinge (PINK:GETI B) said today it won expanded FDA clearance for its Sterizone VP4 sterilizer, now cleared to sterilize colonoscopes, gastroscopes and other multi-channel flexible endoscopes of up to 4 channels and 3.5 meters in length. The Swedish medical device firm touted the win, saying that regulatory authorities are becoming more scrutinous of medical device reprocessing, particularly for colonoscopes and other complex minimally invasive surgical devices. “With the new FDA-cleared indications for use, the Sterizone VP4 Sterilizer is the only validated and cleared low-temperature sterilizer available in&n...
Source: Mass Device - July 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Sterilization / Calibration Getinge Source Type: news

Gore touts Viabahn endoprosthesis superiority over PTA in new study
W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months. The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA alone for treating challenging AV access cases, both in terms of primary patency and number of interventions during the study period. Results from the study were published in the Journal of Vascular Surgery, Newark, Del.-based Gore said. “Pa...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular W.L. Gore & Associates Source Type: news

Intact Vascular launches clinical trial of Tack system
Intact Vascular said today it launched the Tack Optimized Balloon Angioplasty III clinical trial investigating its Tack endovascular system along with Medtronic‘s (NYSE:MDT) Admiral drug-coated angioplasty balloon for treating peripheral arterial disease. 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 Tack endovascular system is the ideal adjunct to drug-coated balloon angio...
Source: Mass Device - June 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Intact Vascular Source Type: news

Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S.
This article originally appeared on MassDevice.com’s sister site, Medical Design & Outsourcing. The post Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S. appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Nipro Source Type: news

MassDevice.com +3 | The top 3 medtech stories for February 4, 2016
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. Toshiba bails on non-imaging healthcare biz Toshiba said today that it’s planning to ditch or transfer all of its healthcare business that’s not a part of Toshiba Medical Systems, its imaging division, and forecast higher losses for the rest of the year. A bidding war for Toshiba M...
Source: Mass Device - February 4, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Maquet & Biotronik ink distribution deal for peripheral devices
Getinge‘s (PINK:GETI B) medical subsidiary Maquet Medical Systems USA said today it is partnering with Biotronik to distribute the German firms peripheral vascular devices in the U.S. Maquet will distribute “a range” of Biotronik products designed to treat peripheral artery disease, including its Astron iliac self-expanding stent, Passeo percutaneous transluminal angioplasty balloon products and the line of Fortress reinforced sheaths, the companies said. “Peripheral artery disease is a serious condition that can lead to amputations. Because the global prevalence of this disease is increasing, the n...
Source: Mass Device - February 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Distribution Biotronik Getinge Maquet Cardiovascular LLC Source Type: news

Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total Active: 423 Total On Hold: 176 Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Biotronik expands DCB line with CE Mark for Passeo-18 Lux
Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries. The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval for the device was based on the randomized, controlled Biolux P-I clinical trial, with results published in the Journal of Endovascular Therapy. “Effective treatment of infrapopliteal arterial disease is quite challenging as it involves high-risk patients...
Source: Mass Device - January 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Regulatory/Compliance Vascular Biotronik Source Type: news

Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals & Supplements Approved Originals: 3 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 30 Total On Hold: 27 Summary of PMA Supplements Under Review Total Under Review: 583 Total Active: 433 Total On Hold: 150 Summary of All PMA Submissions Originals: 4 Supplements: 75 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 69 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 193.4 FDA Tim...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Medtronic wins CE Mark for In.Pact Admiral DCB for end-stage renal disease
Medtronic (NYSE:MDT) said today its In.Pact admiral drug eluting balloon won CE Mark approval in the European Union for arteriovenous access to help maintain hemodialysis access in patients with end-stage renal disease. The device is now cleared for preventing restenosis in hemodialysis access sites by opening up the artery and delivering paclitaxel to the vessel wall. A 40 cm catheter shaft will also be made available alongside the expanded indication for the device. “For patients with hemodialysis, maintaining AV access is their lifeline to receiving the care they need to filter waste from their system. I...
Source: Mass Device - January 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Regulatory/Compliance Vascular Medtronic Source Type: news

Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015: Summary of PMA Originals & Supplements Approved Originals: 9 Supplements: 133 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 597 Total Active: 433 Total On Hold: 164 Summary of All PMA Submissions Originals: 7 Supplements: 74 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Ti...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

SurModics picks up Creagh Medical for $32m
SurModics (NSDQ:SRDX) said today it acquired percutaneous transluminal angioplasty balloon catheter developer and manufacturer Creagh Medical for $32 million. The acquisition included an upfront payment of $19 million (€18 million) and a possible $12.8 million (€12 million) based on milestones and revenue achievements. Other terms of the deal were not disclosed. “We are excited about the acquisition of Creagh Medical and the strategic fit of its balloon catheter design and development, and manufacturing capabilities, which are critical to our transformation into a whole-product solutions provider. We are di...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Mergers & Acquisitions Creagh Medical SurModics Inc. 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

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

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

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 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

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 wors...
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