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.
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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 last w...
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 we are ...
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.
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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 freedom from clini...
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,” NEA p...
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 expec...
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 of his renowned medtech career, Dr....
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 lithotripsy pulses ...
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 approval from the FDA for Stellarex earlier...
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
