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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

SurModics wins FDA, CE Mark for low-profile PTA balloon dilation cath
SurModics (NSDQ:SRDX) said today it won both FDA 510(k) clearance and CE Mark clearance in the European Union for its 0.014″ low-profile percutaneous translumioal angioplasty balloon dilation catheter with plans to launch the device in the coming months. The newly launched PTA ballon catheter comes equipped with the company’s Serene hydrophilic coating, allowing for low friction and particulates, the Eden Prairie, Minn.-based company said. SurModics said the clearance and coming launch of the low-profile PTA cath is a continuation of the company’s strategy to supply whole-product vascular solutions. ...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular SurModics Inc. Source Type: news

7 medtech stories we missed this week: Sept. 15, 2017
[Image from unsplash.com]From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to lead its Restrata wound matrix study. The study will surgery the clinical outcomes of Restrata treatments for diabetic foot ulcers and test for effectiveness and safety. Restrata is a fully synthetic wound matrix that is FDA-cleared for ...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Dental Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Surgical Acera Surgical Contego Medical Fresenius MedTech OBP Medical Pinnacle Sciences Plusoptix Telos Source Type: news

Japan approves Medtronic ’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfar for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The In.Pact Admiral DCB has demonstrated superior one-year clinical outcomes in Japan and across Medtronic In.Pact SFA clinical trials, providing patients with an improved restoration of blood flow and reduced need for additional revasc...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Vascular Wall Street Beat Medtronic Source Type: news

Ra Medical CEO Irwin aims for Feb 2018 IPO
In May, Ra Medical received a nod from the FDA for its Dabra arteriosclerosis laser, clearing it for use in the US. It was a decision the company had been waiting on for approximately 3 years, CEO Dean Irwin told MassDevice.com in an interview, and signaled a significant shift forward. “In 2014, we submitted to the FDA, and here in 2017, just on May 24th, we received the go ahead to begin marketing in the United States,” Irwin said. Ra Medical won CE Mark approval in the European Union last October, giving the company time to launch in the region, which it’s been operating in for several mo...
Source: Mass Device - August 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Regulatory/Compliance Ra Medical Source Type: news

U.S. Hospitals Set Record for Fast Heart Attack Care
There's never been a better time to be treated for a heart attack. U.S. hospitals have set a record for how quickly they open blocked arteries, averaging under one hour for the first time since these results have been tracked. More than 93 percent of patients now have their arteries opened within the recommended 90 minutes of arrival. "Things have definitely improved" from a decade ago, when less than half of heart attack patients were treated that fast, said Dr. Fred Masoudi, a University of Colorado cardiologist who led a recent report examining response times. It's based on records from about 85 percent of U.S...
Source: JEMS Patient Care - July 31, 2017 Category: Emergency Medicine Authors: Marilynn Marchione, Chief Medical Writer, Associated Press Tags: Patient Care Cardiac & Resuscitation News Source Type: news

U.S. Hospitals Set Record for Fast Heart Attack Care
There's never been a better time to be treated for a heart attack. U.S. hospitals have set a record for how quickly they open blocked arteries, averaging under one hour for the first time since these results have been tracked. More than 93 percent of patients now have their arteries opened within the recommended 90 minutes of arrival. "Things have definitely improved" from a decade ago, when less than half of heart attack patients were treated that fast, said Dr. Fred Masoudi, a University of Colorado cardiologist who led a recent report examining response times. It's based on records from about 85 percent of U.S...
Source: JEMS: Journal of Emergency Medical Services News - July 31, 2017 Category: Emergency Medicine Authors: Marilynn Marchione, Chief Medical Writer, Associated Press Tags: Patient Care Cardiac & Resuscitation News Source Type: news

Intact Vascular launches Toba II BTK trial in EU
Intact Vascular today announced the European launch of the Toba II BTK clinical trial of its Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for treating critical limb ischemia. The 1st European patient in the trial was enrolled by Dr. Marianne Brodmann and Dr. Peter Reif at Austria’s Medical University Graz, the Wayne, Penn.-based company said. “We are pleased to be the 1st center in Europe to commence enrollment in Toba II BTK. I believe the Tack endovascular system is a very promising technology designed to optimize dissection repair while l...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Intact Vascular Source Type: news

FDA OKs Intact Vascular IDE app for 6-month endpoint in BTK Tack angioplasty trial
Intact Vascular said today that the FDA approved an investigational device exemption supplemental application to modify the primary endpoint in a below-the-knee clinical trial of its Tack optimized balloon angioplasty from 12 months to 6 months. 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, the Wayne, Penn.-based company said. The Toba II BTK study is a prospective, multi-center, single-arm study which looks to investigate the saf...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Vascular Intact Vascular Source Type: news

Barriers to Achieving Optimal Door-to-Balloon Time in Japan: Interview with Dr. Shun Kohsaka
In this interview, co-author Dr.Shun Kohsaka of the Department of Cardiology at Keio University School of Medicine in Tokyo, Japan, discusses a study, recently published in the Japanese Circulation Society's Circulation Journal, demonstrating that door-ro-balloon time in half of STEMI cases in Japan is greater than 90 minutes.(Posted in collaboration with TCROSS NEWS.) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 30, 2017 Category: Cardiology Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 15, 2017
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. Johnson & Johnson Innovation backs 3D printing, coatings and contact lenses Johnson & Johnson Innovation, the incubation arm of healthcare giant Johnson & Johnson, said today that it’s investing in a variety o...
Source: Mass Device - June 15, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

China ’ s Venus Medtech snaps up TAVR device developer InterValve
Chinese heart valve maker Venus Medtech said today it acquired U.S.-based transcatheter aortic valve replacement device developer InterValve for an undisclosed amount. Intervalve produces the V8 and TAV8 aortic valvuloplasty balloon catheters designed for performing percutaneous balloon angioplasty procedures and for pre and post-dilation during TAVR procedures. Venus said that the shape of the balloon helps protect the valve annulus structure and minimize expansion of the valve. Both the V8 and TAV8 balloons have FDA approval and CE Mark approval in the European Union, Venus Medtech said. “The balloon of Interv...
Source: Mass Device - June 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Catheters Mergers & Acquisitions InterValve Inc. Venus Medtech Source Type: news

Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease. Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These procedures can cause target lesion revascularization, requiring the need for repeat treatments. Alucent Medical’s photo-activated drug therapy, NVS, is designed to build natural scaffolding and keep the vessel open, according to the S...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Vascular alucentmedical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 16, 2017
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. Corindus touts high success rate in CorPath 200 PCI registry study Corindus Vascular Robotics today released post-market findings from the Precision registry study of its CorPath 200 system used during percutaneous coronary int...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Abbott recalls heart catheters on balloon sheath issue
Abbott (NYSE:ABT) is recalling some 450,000 coronary catheters on the risk that removing a protective balloon sheath can damage the ballon during angioplasty procedures. In a March 22 letter to customers, Abbot said the recall affects its NC Trek RX and NC Traveler RX coronary dilatation catheters and the NC Tenku RX PTCA balloon catheter. “Product from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon,” Abbott said. “If excessive force is required to remove the balloon sheath, the sheath m...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Food & Drug Administration (FDA) Recalls Regulatory/Compliance Abbott Source Type: news

Boston Scientific looks to lead the drug-eluting PAD market
Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis. For patients treated with bare balloons, half must have the procedure done again because their arteries have re-clogged. Stents improved that rate to 1 of every 3 or 4 patients, Mirviss told Drug Delivery Business News. But drug-coated balloons designed to control scar tissue formation can bring t...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Vascular Boston Scientific 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

Contego Medical Receives CE Mark for Vanguard IEP(TM) Peripheral Balloon Angioplasty System with Integrated Embolic Protection
RALEIGH, N.C., April 27, 2017 -- (Healthcare Sales & Marketing Network) -- Contego Medical, LLC announced today that it has received CE Marking of its Vanguard IEP™ Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Company inte... Devices, Interventional, Regulatory Contego Medical, Vanguard IEP, Balloon Angioplasty, Embolic Protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 27, 2017 Category: Pharmaceuticals Source Type: news

Mercator enrolls first patient in BTK vascular disease trial
Mercator MedSystems said today that the 1st patient was enrolled in its Tango clinical trial. The trial is evaluating Mercator’s Bullfrog micro-infusion device for the adventitial delivery of temsirolimus below the knee in patients with critical limb ischemia. The Tango trial is the 4th ongoing clinical trial using the Bullfrog device in below the knee applications for patients with peripheral artery disease. Mercator said that outside of trials using its Bullfrog drug delivery system, there is only 1 other intravascular drug delivery tech, a paclitaxel-coated angioplasty balloon, being investigated in a U.S. st...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Vascular Mercator MedSystems Pfizer Inc. Source Type: news

Commercializing the first da Vinci surgical robot: Lessons you need to know
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Daniel Hawkins is the President and CEO of Shockwave Medical. He began his career in marketing and business development roles for Advanced Cardiovascular Systems, otherwise known as ACS, which is now part of Abbott Vascular. Following ACS, he held senior roles in general management, marketing, and business development with a number of private and public companies. Daniel started the marketing department at Intuitive Su...
Source: Mass Device - April 7, 2017 Category: Medical Equipment Authors: MassDevice Tags: Blog medsider Source Type: news

Shockwave Medical launches lithoplasty trial
Shockwave Medical said today it enrolled the 1st patient in the Disrupt PAD III trial of its Lithoplasty system, aiming to explore the system’s effectiveness at treating heavily calcified lesions in the leg compared to traditional angioplasty. The company’s Lithoplasty device is designed to use intermittent lithotripsy pulses to disrupt superficial and deep vascular calcium and an angioplasty balloon to expand blockages at low pressures to restore blood flow. The 334-patient trial will have a primary goal of achieving less than 30% residual stenosis without the need for stenting, and al...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Shockwave Medical Source Type: news

Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, according to Intact. Get the full story at our sister site, Drug Delivery Business News. The post Intact Vascular finishes patient enrollment for angioplasty clinical trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Vascular Wall Street Beat Intact Vascular 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

FDA Warns on Use of Balloon Angioplasty Devices Outside Approved Indications (FREE)
By Amy Orciari Herman Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM Balloon angioplasty devices have not been cleared to treat autonomic dysfunction, the FDA warned on Wednesday.Some clinicians have … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - March 8, 2017 Category: Primary Care Source Type: news

FDA warns of off-label balloon angioplasty to treat autonomic disorders
The FDA today released a safety communication concerning risks associated with off-label balloon angioplasty procedures intended to treat autonomic dysfunction, warning of serious health risks and a lack of supporting data. The procedure, called trans venous autonomic modulation, involves a catheter being threaded into a patients’ venous system where an attached balloon is inflated to widen the vein walls. Physician Dr. Michael Arata claims the procedure can treat the signs and symptoms of autonomic dysfunction in a number of neurological disorders, according to the FDA. The federal watchdog warned of possible seriou...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Neurological Source Type: news

FDA Again Warns on Balloon Angioplasty for Neurologic Disorders
(MedPage Today) -- Says transvascular autonomic modulation is off-label and dangerous (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 8, 2017 Category: American Health Source Type: news

FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication
TVAM consists of threading a catheter into a patient ’s venous system, such as the jugular vein, where a balloon attached to the catheter inflates to widen the vein walls. At least one physician, Dr. Michael Arata, claims the procedure treats the signs... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 8, 2017 Category: Medical Equipment Source Type: news

4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously, Shook was Co-founder, Director, P...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news

MassDevice.com +5 | The top 5 medtech stories for February 27, 2017
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. Integra LifeSciences slides on Q4 sales miss Integra LifeSciences met the consensus earnings forecast for its 4th-quarter earnings, but saw share prices slide nevertheless after it missed Wall Street’s top-line outlook la...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: MassDevice Tags: Blog News Well Plus 5 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

FDA green-lights Cagent Vascular ’ s Serranator Alto PAD balloon catheter
Cagent Vascular said today that it won 510(k) clearance from the FDA for its Serranator Alto balloon catheter, which is designed to treat peripheral artery disease. The Wayne, Pa.-based company bills its serration technology, created by co-founder and CMO Dr. Peter Schneider, as a way to improve arterial expansion during balloon angioplasty for PAD. The device’s balloon has serrated external metal strips designed to create linear “micro-serrations,” according to Cagent’s website. “A new approach to vessel dilatation is long overdue for treatment of diseased peripheral arteries. Today...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Cagent Vascular Peripheral Artery Disease 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

Intact Vascular's Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) Clinical Trial Commences Enrollment with First Implant of the Tack Endovascular System(R)
WAYNE, Pa.--(Healthcare Sales & Marketing Network)--Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) cli... Devices, Interventional Intact Vascular, TOBA II, BTK, Tack Endovascular, peripheral arterial disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 13, 2017 Category: Pharmaceuticals 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

UPDATE: Medtronic wins Health Canada license for drug-coated balloon, touts Japanese data
Medtronic (NYSE:MDT) touted 1 year data from the In.Pact SFA Japan trial of its drug-coated balloon compared to plain balloon angioplasty. The company also said today it won regulatory approval in Canada for its In.Pact Admiral DCB in patients with peripheral artery disease in the upper leg. The trial enrolled 100 patients, 68 of whom were treated with the drug-coated balloon and 32 with plain balloon angioplasty. Primary patency, or restoration of adequate blood flow through the treated segment of diseased artery, was 89.2% for the DCB group and 48.4% for the control group at 12-months follow-up. Get the full story at our...
Source: Mass Device - February 9, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Vascular Wall Street Beat Medtronic Source Type: news

FDA OKs Medtronic trial for In.Pact Admiral DCB in renal disease
Medtronic (NYSE:MDT) said today that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The Fridley, Minn.-based company said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint for the 330-patient study is patency of dialysis fistulas through 6 months and the primary safety endpoint is major adverse events through 30 days. Additional endpoints include reducing access circuit related events. Get the full st...
Source: Mass Device - January 26, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Regulatory/Clearance Medtronic Source Type: news

Spectranetics touts high primary patency, low CD-TLR for Stellarex DCB data in complex cases
Spectranetics (NSDQ:SPNC) today released 12-month data from the Illumenate global study of its Stellarex drug-coated balloon in treating peripheral artery disease in superficial femoral and popliteal arteries, touting a high rate of primary patency in patients with complex lesions. The 371-patient Illumenate global study included lesions which were “highly complex,” according to the Colorado Springs, Colo.-based company, and a high proportion of chronic total occlusions and severe calcifications, at 31% and 41%, respectively. At 1-year, data indicated a primary patency rate of 81.4%, with fr...
Source: Mass Device - January 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Spectranetics Corp. Source Type: news

Intact Vascular lifts Series B to $46m
Intact Vascular said today it lifted the total raised in its Series B financing round to $46 million after receiving additional investments to the round, which initially closed in May 2015. Additional capital was invested by current investors New Enterprise Associates, Quaker Partners and H.I.G. BioHealth Partners, the Wayne, Penn.-based company said. “The team at Intact Vascular has made substantial progress since our initial investment. Intact is poised to bring a truly innovative endovascular technology to the peripheral vascular market place, and we are pleased to be a part of that important effort,” N...
Source: Mass Device - January 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Vascular Intact Vascular Source Type: news

QT Vascular subsidiary TriReme lands GPO deal with HealthTrust
QT Vascular said yesterday that its TriReme Medical subsidiary inked a group purchase agreement with Healthtrust Purchasing Group. Through the newly signed deal, Healthtrust will gain access to TriReme’s portfolio of specialty angioplasty balloons designed to treat blood vessel blockage due to arterial disease, QT Vascular said. Nashville, Tenn.-based HealthTrust serves more than 1,400 acute care facilities and members at more than 22,600 locations which include ambulatory surgery centers, phsyician practices, long-term care and alternate care sites, the company said. QT Vascular said that the agreement is not e...
Source: Mass Device - December 21, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Vascular QT Vascular TriReme Medical Inc. Source Type: news

Endurance through criticism: The legendary career of Dr. John Simpson
Avinger executive chairman Dr. John Simpson Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Dr. John Simpson.  Even if you’re a medical device newbie, you’ve probably heard of him.  He’s credited with inventing and commercializing the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty (PTCA).  This single idea created the field of interventional cardiology as we know it today. Over the course...
Source: Mass Device - December 6, 2016 Category: Medical Equipment Authors: Scott Nelson Tags: Blog Avinger medsider Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 22, 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. SentreHeart recalls FindrWIRZ Guidewire System over coating separation issues SentreHeart is recalling a select number of its FindWIRZ guidewire systems over PTFE coating separation issues, according to an FDA release posted to...
Source: Mass Device - November 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Shockwave Medical raises $45m Series C for Lithoplasty device
Shockwave Medical said today that it raised a $45 million Series C round for the Lithoplasty device it developed to treat calcified vasular lesions. Fremont, Calif.-based Shockwave said Sectoral Asset Management led the round, joined by new backer T. Rowe Price and existing investors Sofinnova Partners, Venrock, RA Capital, Deerfield, Ally Bridge Group and others. Shockwave said it plans to use the funds to expand the commercial footprint for the Lithoplasty device, which won 510(k) clearance from the FDA in September for treating peripheral artery disease. The device is designed to use intermittent lit...
Source: Mass Device - November 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Vascular Wall Street Beat Shockwave Medical 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: Novel Drug-Coated Balloon Promising for Periphery
(MedPage Today) -- Stellarex beat angioplasty alone in fairly complex PAD population trial (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - November 3, 2016 Category: Cardiology 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

Medtronic wins FDA nods for TrailBlazer peripheral support cath
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system. The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as the TrailBlazer, are commonly used in endovascular procedures to treat patients with peripheral artery disease. “Medtronic is committed to providing physicians with meaningful innovations and therapy choices to enhance their peripheral t...
Source: Mass Device - September 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular Medtronic Source Type: news

Medtronic touts low CD-TLR rates, strong durability in 3-year In.Pact Admiral DCB study | VIVA 2016 Roundup
Medtronic (NYSE:MDT) this week released data from 2 clinical studies evaluating its In.Pact Admiral drug-coated balloon for treating claudication and restenosis, touting sustained durability at 3-years. Results were presented at the Vascular Interventional Advances 2016 conference in Las Vegas this week. 3-year outcomes from the In.Pact SFA trial showed Medtronic’s balloon had long-term clinical benefit superior to plain balloon angioplasty, reported Dr. Prakash Krishnan of New York’s Mt. Sinai Heart. “The In.Pact Admiral is the only DCB to-date with superior performance...
Source: Mass Device - September 22, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Endoscopic / Arthroscopic C.R. Bard Medtronic Mercator MedSystems Shockwave Medical Source Type: news

FDA approves 6-month endpoint in trial of Bard ’ s Lutonix 014 drug-coated balloon
C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the knee. The Lutonix devices are designed to elute the anti-stenosis drug paclitaxel as the balloon is inflated to dilate narrowed arteries. The federal safety watchdog approved a 6-month safety...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Drug-Device Combinations C.R. Bard Peripheral Artery Disease Source Type: news

Medtronic's IN.PACT Drug-Coated Balloon: First to Gain FDA OK for Treatment of In-Stent Restenosis in the Peripheral Vessels
The FDA has approved the first drug-coated balloon in the United States for the treatment of in-stent restenosis (ISR) in the peripheral arteries: Medtronic's IN.PACT Admiral drug-coated balloon (DCB). One-year outcomes from the IN.PACT Global ISR Imaging Cohort were presented at last year's VIVA meeting: the primary patency rate was 88.7% the clinically-driven target revascularization (CD-TLR) rate was 7.3%, outcomes that begin to approach what has been seen in the coronaries. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 14, 2016 Category: Cardiology Source Type: news