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Can New Indication Give Medtronic Edge in DCB?
Medtronic is entering  a bold new chapter in the continued evolution of its drug-coated balloon technology (DCB). The Dublin-based firm said on Monday, that it received a nod from FDA for the IN.PACT Admiral DCB to treat long superficial femoral artery (SFA) lesions up to 360mm in patients suffering from peripheral artery disease (PAD).  Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, including long lesion, in-stent restenosis, and chronic total occlusion groups with lesion lengths greater than 180mm. Across these groups, a total of 227 subjects with mean l...
Source: MDDI - April 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter
Company received FDA 510(k) clearance Continued progress in R&D whole-product solutions pipeline EDEN PRAIRIE, Minn. -- (Healthcare Sales & Marketing Network) -- Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologi... Devices, Interventional, FDA Surmodics, percutaneous transluminal angioplasty, balloon catheter (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 23, 2018 Category: Pharmaceuticals Source Type: news

Intact Vascular raises $20m in Series C
Intact Vascular said today it raised $20 million in a Series C round of financing, with funds slated to support the company’s Tack endovascular system through the FDA pre-market approval process. The round was joined by major participants New Enterprise Associates, H.I.G. BioVentures and Quaker Partners, the Wayne, Penn.-based company said. The funding is slated to come in two stages or tranches, with the second closing later this year. Late last week, the company posted an SEC filing showing that it had raised $10 million in a round of mixed financing, and that it was seeking an additional $11.8 million before closi...
Source: Mass Device - April 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Wall Street Beat Intact Vascular Source Type: news

Intact Vascular raises $10m, looks to raise $12m more
Intact Vascular has raised $10 million in a new mixed round of financing, according to an SEC filing posted this week. Money in the round comes from 3 anonymous investors, with the first sale noted on April 5, according to the filing. The company has not yet officially stated how it plans to spend the funds, but noted that $2.1 million of the proceeds will be used to pay its executive officers, directors or promoters. Intact Vascular is looking for an additional $11.8 million in the round to close out at $21.8 million, according to the filing. Last July, Intact Vascular announced the European launch of the Toba II BTK clin...
Source: Mass Device - April 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Intact Vascular Source Type: news

Intact Vascular Has a Unique Way to Treat PAD Patients
Intact Vascular is hoping to have a below-the-knee (BTK) indication for its Tack Endovascular System in 2020 company executives, told MD+DI. Data from the Tack Optimized Balloon Angioplasty Below the Knee (TOBA BTK) clinical trial, an initial study of the technology, was published in the current issue of Catheterization and Cardiovascular Intervention. The published data could help pave the way for an approval.  The Tack Endovascular System is an implant for the precision dissection repair following balloon angioplasty and received CE mark in 2012. The device is designed to help maintain vessel integrity and impr...
Source: MDDI - March 27, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Contego Medical launches Neuroguard IEP trial
Contego Medical said today it launched the Performance I trial of its Neuroguard IEP 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection designed to treat carotid artery stenosis. The first patient in the trial has already been enrolled and treated at Skopje, Macedonia’s University Clinic of Cardiology by Dr. Saško Kedev, the Raleigh, N.C.-based company said. “We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This 3-in-1 system inclu...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Contego Medical Source Type: news

Backlash Over Nixing of CMS Add-On Payments for DCBs
(MedPage Today) -- Superiority of drug-coated balloon angioplasty not reflected in reimbursement, group suggests (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 5, 2018 Category: American Health Source Type: news

Medtronic ’ s In.Pact Admiral drug-coated balloon succeeds in two-year study, critical limb ischemia analysis
Medtronic (NYSE:MDT) touted data today from a two-year study of its In.Pact Admiral drug-coated balloon in patients with peripheral artery disease in Japan, as well as the results from a critical limb ischemia subgroup analysis from its In.Pact Global trial. The company’s In.Pact SFA Japan study enrolled 100 patients and randomized them to receive either the drug-coated balloon or plain balloon angioplasty. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic’s In.Pact Admiral drug-coated balloon succeeds in two-year study, critical limb ischemia analysis appeared first on...
Source: Mass Device - January 30, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Pharmaceuticals Wall Street Beat Medtronic 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 Primary Care)
Source: MedPage Today Primary Care - December 26, 2017 Category: Primary Care Source Type: news

Bringing Robotics into the Cath Lab to Protect Physicians
Percutaneous Coronary Intervention (PCI, or angioplasty with stent) is a common procedure used to treat patients with obstructive coronary artery disease, with an estimated 600,000 procedures performed annually in the United States. PCI has a low risk of complications for patients, but that's not the case for clinicians. Patients receive a dose of radiation during a PCI procedure, which takes anywhere from 30 minutes to a few hours. Interventional cardiologists and cardiac catheterization laboratory personnel are exposed to ionizing radiation all day, every day. Protective measures, such as radiation safety caps,...
Source: MDDI - December 15, 2017 Category: Medical Devices Authors: Heather R. Johnson Tags: Medical Device Business Source Type: news

7 medtech stories we missed this week: Dec. 8, 2017
[Image from unsplash.com]From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press release that it has signed its first European distribution deal with Italian company Moss and has completed its first commercial order. Moss has exclusive distribution rights to distribute in Italy, Germany, Switzerland and the U.K. 2. Elanix, Dermacon sign wound management development deal Elanix Biotechnologies and Dermacon...
Source: Mass Device - December 8, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiac Assist Devices Cardiovascular Diagnostics Food & Drug Administration (FDA) Hospital Care Pain Management Regulatory/Compliance Cagent Vascular CSA Medical Inc. Dermacon Elanix Life Spine Inc. MedTech Minimus Spin Source Type: news

Cordis Comes Back for Another Stent
Cordis is getting back into the coronary stent game. The company, which is now owned by Cardinal Health, landed exclusive rights to sell Medinol's coronary stent portfolio in the U.S. Milpitas, CA-based Cordis is already selling Medinol's NIRxcell cobalt-chromium bare-metal stent and, assuming FDA approves Medinol's EluNIR drug-eluting stent (DES), Cordis will distribute it as well. Medinol is based in Israel. In addition to the Medinol agreement, Cordis recently launched the Tryton Side Branch Stent and two percutaneous transluminal coronary angioplasty (PTCA) balloon catheters. The Medinol agreement, along with the ...
Source: MDDI - October 31, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Andreas Roland Gruentzig, the Man Andreas Roland Gruentzig, the Man
A fascinating profile of Andreas Gruentzig, the renowned cardiologist who first developed balloon angioplasty, and is considered the father of modern-day percutaneous coronary intervention.European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 26, 2017 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

7 medtech stories we missed this week: Sept. 22, 2017
[Image from unsplash.com]From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, clinic and directly to patients without a prescription. The MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that can conform to a patient’s skin at a planned incision or insertion si...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Diagnostics Food & Drug Administration (FDA) Laboratory Instruments/Laboratory Supplies mHealth (Mobile Health) Research & Development Vascular Bioventus LLC Contego Medical Covalon Technologies Getinge Guerbe Source Type: news

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