Peripheral Vascular Disease (PVD) News 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.FDA Investigating Paclitaxel Coated Balloons and Eluting Stents
A meta-analysis of randomized trials recently concluded that there is an increased risk of death for patients treated with paclitaxelâ€coated balloons and paclitaxel-eluting stents in the femoral and/or popliteal arteries of the lower limbs. The analysis, which was published in late December in the Journal of the American Heart Association, has prompted FDA to investigate.
The agency issued a letter last week recommending that doctors continue to monitor patients who have been treated with these devices and discuss the benefits and risks of all av...
Source: MDDI - January 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news
FDA probes paclitaxel-eluting stents, balloons
The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices.
The agency is “evaluating” the new information presented by the study and recommended that healthcare providers continue closely watching patients who have been treated with the drug-eluting devices.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA probes paclitaxel-eluting stents, balloons appeared first o...
Source: Mass Device - January 18, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Vascular Wall Street Beat Boston Scientific Medtronic Source Type: news
PQ Bypass raises $60m
PQ Bypass said today that it raised $60 million in an equity round of financing to help support its technology intended for treating patients with peripheral artery disease.
The round was led by Deerfield Management and joined by existing investors including Seroba Life Sciences and MedTech Venture Partners, the Sunnyvale, Calif.-based company said.
“With this funding we continue our pursuit of the science that will bring us closer to commercial release of this important advancement in the care of patients with PAD. We are very fortunate to have Deerfield as an anchor investor and, together, we are working to develo...
Source: Mass Device - January 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat PQ Bypass Source Type: news
German hospitals are first to use Wayne firm's blood-vessel repair system
Intact Vascular Inc., a Wayne-based developer of medical devices, said Monday it has launched its Tack Endovascular System in the European Union, where the product's first commercial use has taken place at multiple hospitals in Germany.
Dr. Michael K.W. Lichtenberg, chief of Klinkum Arnsberg, an angiology clinic and venous center in Germany, said based on his initial experience with system he believes it will become standard of care for patients undergoing peripheral artery disease interventions.… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - January 8, 2019 Category: Pharmaceuticals Authors: John George Source Type: news
German hospitals are first to use Wayne firm's blood-vessel repair system
Intact Vascular Inc., a Wayne-based developer of medical devices, said Monday it has launched its Tack Endovascular System in the European Union, where the product's first commercial use has taken place at multiple hospitals in Germany.
Dr. Michael K.W. Lichtenberg, chief of Klinkum Arnsberg, an angiology clinic and venous center in Germany, said based on his initial experience with system he believes it will become standard of care for patients undergoing peripheral artery disease interventions.… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 8, 2019 Category: Biotechnology Authors: John George Source Type: news
Medtech veteran Reggie Groves on leading with ‘patients first’
In guiding Medtronic through the Fidelis lead recall, medtech veteran Reggie Groves always took a “patients first” perspective. At DeviceTalks West 2018, Groves explained how her time at Medtronic influenced her as a leader and how she has brought those lessons into her role as CEO of Reva Medical.
Once the world’s most popular defibrillator lead, Medtronic’s Fidelis leads were in hundreds of thousands of patients in the U.S. So when the device began delivering random, painful shocks to people about a decade ago, Medtronic officials were worried. That included Reggie Groves, who was charged with run...
Source: Mass Device - January 7, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Featured Recalls Vascular Wall Street Beat DeviceTalks West Medtronic Reva Medical Inc. Source Type: news
Will Drug-Eluting Devices Suffer from JAHA Publication?
A meta-analysis of randomized clinical trials concluded that there is an increased risk of death for patients treated with paclitaxelâ€coated balloons and stents in the femoral and/or popliteal arteries of the lower limbs. At least two drug-eluting device trials have been paused since this analysis was published late last month in the Journal of the American Heart Association (JAHA).
Investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials have paused recruitment efforts in response to the published findings. Konstantinos Katsanos, MD, PhD ...
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Business Source Type: news
Familial Hypercholesterolemia and Risk of PAD and CKD Familial Hypercholesterolemia and Risk of PAD and CKD
Is there an increased risk of peripheral artery disease and chronic kidney disease among individuals with familial hypercholesterolemia?Journal of Clinical Endocrinology & Metabolism (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 3, 2019 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news
Two PAD Trials Paused Over Paclitaxel Balloon, Stent Concerns Two PAD Trials Paused Over Paclitaxel Balloon, Stent Concerns
An increased risk of death observed in a recent meta-analysis prompted the action, along with plans for a special forum on drug elution in peripheral artery disease.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 19, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
Investigators hit pause on trials following concerns over paclitaxel-coated devices
A meta-analysis published in the Journal of the American Heart Association last week suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons.
The results of the study prompted investigators for two trials to stop their studies. Meanwhile, leaders in the endovascular community have promised to hold a special forum to discuss the study’s findings.
Get the full story at our sister site, Drug Delivery Business News.
The post Investigators hit pause on trials following concerns over p...
Source: Mass Device - December 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Drug-Eluting Stents Featured Pharmaceuticals Vascular Source Type: news
Appropriate Use Criteria Released for Peripheral Artery Intervention
TUESDAY, Dec. 18, 2018 -- Appropriate use criteria have been developed for peripheral artery intervention (PAI) in peripheral artery disease, according to a report published online Dec. 17 in the Journal of the American College of Cardiology.
Steven... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 18, 2018 Category: Pharmaceuticals Source Type: news
How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?
Implantable technologies have come a long way over the years, and advancements in micro and nanotechnologies have helped device developers continue to push the envelope even further. Within the realm of drug delivery, advances in nanotechnologies have consistently improved patient outcomes by enabling sustained drug delivery to help treat chronic conditions. These scalable technologies have even offered localized drug delivery that can further improve bioavailability.
While many of these technologies offer a variety of opportunities, we’re still eagerly awaiting to see the impact of these advancements onc...
Source: MDDI - November 29, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: BIOMEDevice San Jose Implants Source Type: news
Prevalence of PAD Is Higher in Persons Living With HIV Prevalence of PAD Is Higher in Persons Living With HIV
This study investigates.JAIDS: Journal of Acquired Immune Deficiency Syndromes (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 29, 2018 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news
5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA
At last week's Vascular Interventional Advances (VIVA) Annual Meeting in Las Vegas, Medtronic presented five-year final outcomes from its IN.PACT SFA Trial. Of note: Medtronic is the first company to present long-term five-year outcomes for a commercially-available drug-coated balloon (DCB). The data not only reinforced the safety, durability, and efficacy of the IN.PACT Admiral DCB, as seen in previous studies, but also reaffirmed its use as a frontline therapy for the treatment of peripheral artery disease (PAD). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 13, 2018 Category: Cardiology Source Type: news
Doctors Not Pushing Smokers With Peripheral Artery Disease to Quit Doctors Not Pushing Smokers With Peripheral Artery Disease to Quit
Smokers with peripheral artery disease (PAD) would do well to quit smoking, but many doctors may not be giving them enough support to do it, a recent study suggests.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 12, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news
