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.
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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 may damage th...
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 the rate down to 1 in...
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 wil...
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. study for ...
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 Surgical where...
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 all patients who do no...
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 serious ri...
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 âs 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
