FDA clears Contego Medical ’ s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection. Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January. A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said. “We are thrilled to have achieved this milestone for the first of several devices Conteg...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news

Teleflex to acquire QT Vascular assets, takes option on Chocolate Heart DCB
QT Vascular said today it inked a deal to sell its non-drug coated coronary products to Teleflex (NYSE:TFX), including its Chocolate XD and Glider, with an option to purchase its Chocolate Heart drug-coated coronary balloon catheter which is currently under development. Singapore-based QT Vascular has not released any financial details of the deal, but said that it will continue to develop and market its other products, including its Chocolate Touch drug-coated percutaneous transluminal angioplasty balloons. The company said it is currently enrolling patients in an IDE trial of the Chocolate Touch device. Read the whole...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Drug-Device Combinations Vascular QT Vascular Teleflex Source Type: news

SurModics acquires Embolitech thrombectomy tech for $5m
SurModics (NSDQ:SRDX) said today it inked a deal with Embolitech to acquire its thrombectomy platform the and associated intellectual property in a deal worth $5 million up front, with additional payments based on regulatory milestones. The newly acquired tech platform is designed for use in the peripheral vasculature to remove hard blood clots, Eden Prairie, Minn.-based SurModics said. SurModics added that it plans to leverage its design, development and manufacturing capabilities to advance the platform into different peripheral and vascular applications. “We are pleased to sign an agreement with Surmodics for th...
Source: Mass Device - May 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Mergers & Acquisitions Vascular SurModics Inc. Source Type: news

U.S. Drug-Coated Balloons Market Threatened by Reimbursement Cuts and Competitive Pressure
Conclusion Launched in late 2014, DCB sales exploded in 2015, following the establishment of the TPT payment. Rapid growth persisted through 2016 and 2017, fueled by favorable reimbursement, strong clinical results, and new indications for ISR, long lesions, and AV access. The expiration of the TPT payment threatens to cause DCB unit sales and ASPs to contract in 2018. The DCB space is fiercely competitive, and market leaders Medtronic and C. R. Bard are constantly refining their respective DCB portfolios to gain the edge in the high-profile market. Spectranetics threw its hat in the ring in 2017, but is yet to make a subs...
Source: MDDI - May 7, 2018 Category: Medical Devices Authors: Sean Collins and Kamran Zamanian Tags: Business Source Type: news

SurModics wins FDA nod for low-profile PTA balloon dilation catheter
SurModics (NSDQ:SRDX) said yesterday it won FDA 510(k) clearance for its .018″ low-profile percutaneous transluminal angioplasty balloon dilation catheter designed for peripheral vascular use. The newly cleared low-profile catheter features the Eden Prairie, Minn.-based company’s low-friction, low-particulate Serene hydrophilic coating with a range of between 2mm to 10mm. “We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product offerings. With the .018” Low-Profile PTA balloon catheter, we continue building upon Surmodics’ portfolio of...
Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular SurModics Inc. 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.--(BUSINESS WIRE)-- Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad...This story is related to the following:Catheters (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - April 24, 2018 Category: Medical Devices Source Type: news

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 lesion le...
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

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

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

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

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

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

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

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