Lithotripsy Advantage in Calcified Peripheral Vessels Holds Up at 1 Year
(MedPage Today) -- ATLANTA -- Intravascular lithotripsy (IVL) beat percutaneous transluminal angioplasty (PTA) for keeping calcified peripheral artery lesions open at 1 year, the Disrupt PAD III trial showed. Primary patency at 1 year was 80... (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 19, 2022 Category: Cardiology Source Type: news

Meds, Exercise Recommended for Stroke Prevention After sICAS
TUESDAY, March 22, 2022 -- For patients with symptomatic intracranial atherosclerotic arterial stenosis (sICAS), initial treatment should comprise medications and exercise, and not percutaneous transluminal angioplasty and stenting, according to a... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 22, 2022 Category: Pharmaceuticals Source Type: news

Today, the @US_FDA issued the draft guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions.pic.twitter.com/UcPPibuz5y
Today, the @US_FDA issued the draft guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions. pic.twitter.com/UcPPibuz5y (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 10, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters are devices intended to treat lesions in the peripheral vascular system.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 10, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medtronic FDA Approval Marks a Turnaround in the Paclitaxel Story
Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for manufacturers and physicians this year, but an FDA approval this week marks a major step forward for this category of devices. The agency approved Medtronic's IN.PACT AV drug-coated balloon for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. AV fistulae are created and used to enable hemodialysis for patients with ESRD. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three ...
Source: MDDI - November 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Boston Scientific Touts Positive Data on Two Paclitaxel Devices
Boston Scientific announced positive data Tuesday for two paclitaxel devices during separate late-breaking clinical trial presentations at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but presentations like these could go a long way toward helping the market rebound. To recap, paclitaxel balloons and stents received some bad press in late December 2018 after a meta-analysis showed...
Source: MDDI - November 5, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Patel-backed company gets FDA designation for product that could reduce leg amputations
A company backed by serial Tampa Bay entrepreneur Dr.  Kiran Patel has secured a key designation that will help advance a product from the medical device company. Concept Medical Inc. has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration for MagicTouch Percutaneous Transluminal Angioplasty, which is a Sirolimu s drug coated balloon catheter, for the treatment of peripheral artery disease. The device is for a disease that takes place below the knee, also… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 12, 2019 Category: Pharmaceuticals Authors: Veronica Brezina-Smith Source Type: news

Bursting Balloon Problem Prompts Cook to Recall Catheters
Cook Medical recalled certain lots of a balloon catheter used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries after receiving multiple complaints of balloons bursting below the rated burst pressure. The company has determined that the problem affects the Advance Enforcer 35 Focal Force PTA Balloon Catheters manufactured with specific balloon material lots manufactured between October 3, 2018, and December 17, 2018. The recall affects about 33 devices that were distributed to the U.S. market between October 29, 2018, to March 21, 2019, FDA said.Â&nb...
Source: MDDI - June 19, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Is the Paclitaxel Narrative Getting Worse?
Paclitaxel drug-coated balloons and drug-eluting stents received some bad press in January after a meta-analysis showed an increased risk of death for patients treated with these devices in the femoral and/or popliteal arteries of the lower limbs. Two drug-eluting device trials were paused after the analysis was published in the Journal of the American Heart Association and the data prompted FDA to investigate. Mike Matson, a medtech analyst at Needham & Co., issued a report in February pointing to evidence and expert opinion that the benefits of using paclitaxel balloons and stents outweigh the risks. Now,...
Source: MDDI - March 13, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook Medical‘s Zilver PTX stent was 10.2% and 16.9% for the PTA group. But the correction reversed those numbers. Get the full story at our sister site, Drug Delivery Business News. The post Late mortality rates ‘...
Source: Mass Device - February 21, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Boston Scientific Cook Medical Medtronic Source Type: news

FDA clears Contego Medical ’ s Vanguard IEP peripheral balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function. “Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues to expand and become more complex, we believe our technology will play a critical role in protecting vulnerable patients from embolic events and thus improve procedural outcomes.” “The Vanguard IEP System is designed t...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Featured Food & Drug Administration (FDA) Regulatory/Compliance Contego Medical peripheral Source Type: news

Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
RALEIGH, N.C., Dec. 7, 2018 -- (Healthcare Sales & Marketing Network) -- Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Int... Devices, Interventional, FDA Contego Medical, Vanguard IEP, Peripheral, Angioplasty, embolic protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 7, 2018 Category: Pharmaceuticals Source Type: news

Philips Takes a Firm Stand in the DCB Market with ILLUMENATE
This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK PAD and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation." Layout of the Land C.R. Bard once held the crown in the DCB market, having gained approval for its Lutonix technology in 2014. The Murray Hill, NJ-based company began losing share when Medtronic launched the IN.PACT Admiral in early 2015. (Editor&...
Source: MDDI - November 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Philips launches below-the-knee PAD trial for drug-coated balloon
Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon. The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia. Get the full story at our sister site, Drug Delivery Business News. The post Philips launches below-the-knee PAD trial for drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Royal Philips Source Type: news

New Data for IN.PACT Drug-Coated Balloon Show Sizable Advantage Over Standard PTA in Peripherals
Dual presentations, made at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meetings in San Diego and Lisbon, showed significant superiority of Medtronic's IN.PACT Admiral drug-coated balloon (DCB) over standard Percutaneous Transluminal Angioplasty (PTA). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 2, 2018 Category: Cardiology Source Type: news