New research shows people with PAD could have an omega-3 deficiency
(Wright On Marketing& Communications) New research published in the March 18 edition of Lipids showed that people who have peripheral artery disease (PAD) have a lower Omega-3 Index compared to those who don't have the disease. Because PAD is essentially atherosclerosis of the leg arteries, researchers in this study believe that patients with PAD may have an omega-3 fatty acid deficiency. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 21, 2019 Category: International Medicine & Public Health Source Type: news

Surmodics shares down following FDA ’s paclitaxel device update
Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of its paclitaxel-coated SurVeil balloon. Get the full story at our sister site, Drug Delivery Business News. The post Surmodics shares down following FDA’s paclitaxel device update appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Vascular Wall Street Beat SurModics Inc. Source Type: news

FDA updates docs on review of paclitaxel devices for PAD
The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data. Get the full story at our sister site, Drug Delivery Business News. ...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Source Type: news

U.K., French regulators probe safety of paclitaxel devices
Taking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease. Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk of late mortality in people treated with paclitaxel devices compared to bare devices. Get the full story at our sister site, Drug Delivery Business News. The post U.K., French regulators probe safety of paclitaxel devices appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Medtronic Source Type: news

Smoking Tied to Peripheral Artery Disease in African-Americans Smoking Tied to Peripheral Artery Disease in African-Americans
African-Americans who smoke cigarettes are more likely than those who don't smoke to develop peripheral artery disease (PAD), a U.S. study suggests.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 28, 2019 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Smoking tied to artery disease in African-Americans
(Reuters Health) - African-Americans who smoke cigarettes are more likely than those who don't smoke to develop peripheral artery disease, a U.S. study suggests. (Source: Reuters: Health)
Source: Reuters: Health - February 27, 2019 Category: Consumer Health News Tags: healthNews 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 mortali...
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

Why does a diabetic wound take longer to heal?
  Diabetes and wound healing have a complicated relationship, namely because many symptoms of the condition impact the body’s ability to recover at an average pace. As a result, patients with diabetes are also more susceptible to infection and other complications during the wound healing process. Even minor cuts, scrapes and blisters require cautious and mindful care. Here are the main reasons why diabetic wound healing is a slower process: Patients with diabetes are prone to delayed wound healing. Blood sugar levels Patients with diabetes have high blood sugar levels, which can inhibit nutrients and oxyg...
Source: Advanced Tissue - January 31, 2019 Category: Dermatology Authors: AdvancedTissue Tags: diabetic wound care diabetic ulcers diabetic foot ulcers diabetic wounds Source Type: news

PAD in HIV-Infected Older Adults on ART PAD in HIV-Infected Older Adults on ART
What do we know about the prevalence of peripheral artery disease among older HIV patients receiving ART?HIV Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 31, 2019 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news

Do you know the warning signs of peripheral artery disease?
Peripheral arterial disease (PAD) is a general term usually referring to arterial blockage of the lower extremities and most commonly a result of the development of atherosclerotic plaque.  It is generally found in patients over the age of 60 years, more often in men than women, and is frequently associated with other areas of arterial disease, including that of heart disease and stroke.   PAD has a variety of manifestations ranging from no symptoms at all to symptoms of leg pain in the muscles… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - January 31, 2019 Category: Pharmaceuticals Authors: Dr. Brooks Whitney Source Type: news

Do you know the warning signs of peripheral artery disease?
Peripheral arterial disease (PAD) is a general term usually referring to arterial blockage of the lower extremities and most commonly a result of the development of atherosclerotic plaque.  It is generally found in patients over the age of 60 years, more often in men than women, and is frequently associated with other areas of arterial disease, including that of heart disease and stroke.   PAD has a variety of manifestations ranging from no symptoms at all to symptoms of leg pain in the muscles… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 31, 2019 Category: Biotechnology Authors: Dr. Brooks Whitney Source Type: news

Smoking Puts Blacks at High Risk of Serious Artery Disease: Study
MONDAY, Jan. 28, 2019 -- Smoking increases black Americans'risk of peripheral artery disease (PAD), a new study warns. PAD -- a narrowing of arteries that provide blood to the arms, legs, brain and other organs such as the kidneys -- can lead to... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - January 28, 2019 Category: General Medicine Source Type: news

Gore touts 12-month Tigris stent study data
W.L. Gore & Associates today released 12-month results from a registry study of its Gore Tigris vascular stent designed to treat peripheral artery disease in the superficial femoral artery and proximal popliteal artery, touting that the device was shown to be safe and effective. Results from the trial were presented at the LINC 2019 meeting in Leipzig, Germany, the Newark, Del.-based company said. The 3rd-generation dual-component stent features a combination of flexible fluoropolymer and single-wire nitinol and is designed to conform to the natural movement of the knee, Gore said. Investigators in the physician-sponso...
Source: Mass Device - January 24, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular W.L. Gore & Associates Source Type: news

Smoking Tied to Peripheral Artery Disease in African-Americans
THURSDAY, Jan. 24, 2019 -- Cigarette smoking is associated with measures of subclinical peripheral artery disease (PAD) in African-Americans, according to a study published online Jan. 23 in the Journal of the American Heart Association. Donald... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 24, 2019 Category: Pharmaceuticals Source Type: news

Black smokers at higher risk for peripheral artery disease
African-Americans who smoke may be at higher risk for developing peripheral artery disease, according to a new study. (Source: Health News - UPI.com)
Source: Health News - UPI.com - January 23, 2019 Category: Consumer Health News Source Type: news

Smoking linked to higher risk of peripheral artery disease in African-Americans
The condition affects 8 to 12 million people in the United States and 202 million worldwide. (Source: National Institutes of Health (NIH) News Releases)
Source: National Institutes of Health (NIH) News Releases - January 23, 2019 Category: American Health Source Type: news

Cigarette smoking associated with increased risk of peripheral artery disease in African-Americans
(American Heart Association) African-Americans who smoke cigarettes are more likely than those who don't to have peripheral artery disease (PAD).Those who smoked more than 20 cigarettes a day significantly increased their likelihood of having PAD.PAD is associated with increased cardiovascular morbidity and mortality and can lead to stroke, erectile dysfunction and loss of limbs. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 23, 2019 Category: International Medicine & Public Health Source Type: news

Smoking linked to higher risk of peripheral artery disease in African-Americans
(NIH/National Heart, Lung and Blood Institute) African-Americans who smoke appear to be at greater risk for peripheral artery disease, or PAD, new research has found. Additionally, the findings suggest that smoking intensity -- how many cigarettes a day and for how many years -- also affects the likelihood of getting the disease. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - January 23, 2019 Category: International Medicine & Public Health Source Type: news

Docs plan industry collab to study paclitaxel devices
Non-for-profit org Viva Physicians said yesterday that it will lead a pan-industry effort to study the use of paclitaxel-eluting devices for the treatment of peripheral artery disease in above-the-knee applications. The initiative comes on the heels of a meta-analysis published in the Journal of the American Heart Association this month showing a potential link between increased long-term mortality outcomes and paclitaxel devices. Get the full story at our sister site, Drug Delivery Business News. The post Docs plan industry collab to study paclitaxel devices appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - January 22, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Boston Scientific Medtronic Royal Philips Source Type: news

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 paclitaxel‐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...
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 de...
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 paclitaxel‐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 follo...
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

Under 40 With High Blood Pressure? Be Wary of Heart Risks
Coronary heart disease, stroke, heart failure or peripheral artery disease were among the risks. (Source: NYT Health)
Source: NYT Health - November 8, 2018 Category: Consumer Health News Authors: NICHOLAS BAKALAR Tags: Blood Pressure Heart Peripheral Vascular Disease Age, Chronological Source Type: news

VIVA 2018 Roundup: Surmodics reports positive one-year data for SurVeil drug-coated balloon
Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. All of the study’s 13 subjects met the acute success measures of safety at 12 months, Surmodics reported, and no participants required re-intervention of either the target lesion or the target vessel. The data also supported improvements in Rutherford classification, resting ankle brachial index and walking impairment after 12 months. “The ongoing positive results from th...
Source: Mass Device - November 7, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Vascular SurModics Inc. Source Type: news

Surmodics reports positive one-year data for SurVeil drug-coated balloon
Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. All of the study’s 13 subjects met the acute success measures of safety at 12 months, Surmodics reported, and no participants required re-intervention of either the target lesion or the target vessel. Get the full story at our sister site, Drug Delivery Business News. The post Surmodics reports positive one-year data for SurVeil drug-coated balloon appeared first on MassDe...
Source: Mass Device - November 7, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Wall Street Beat SurModics Inc. Source Type: news

Medtronic touts five-year data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) today touted five-year data for its In.Pact Admiral drug-coated balloon, highlighting the durability and efficacy of its device in people with peripheral artery disease in the superficial femoral and popliteal arteries. The company presented five-year results from its pivotal In.Pact SFA trial at the 2018 Vascular Interventional Advances conference. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic touts five-year data for In.Pact Admiral drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 6, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Medtronic Source Type: news

Peripheral artery disease treatments may be less effective for diabetics
Research, presented at the Vascular InterVentional Advances annual conference, suggests that standard treatments for peripheral artery disease may not be as effective in diabetes patients. Healio (Source: Society for Endocrinology)
Source: Society for Endocrinology - November 6, 2018 Category: Endocrinology Source Type: news

Few Smokers With PAD Receive Adequate Cessation Support
TUESDAY, Oct. 30, 2018 -- More than one-third of patients with peripheral artery disease (PAD) are active smokers, yet few of them receive evidence-based smoking cessation interventions, according to a study published in the Oct. 16 issue of the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 30, 2018 Category: Pharmaceuticals Source Type: news

What & #039;s Next for Bioresorbable Scaffolds?
Even with new data, the future of bioresorbable scaffolds remains in flux. At TCT 2018 in September, Reva Medical and Abbott Laboratories painted differing pictures with their respective bioresorbable scaffold studies. What now? Dr. Lukasz Koltowski from the Medical University of Warsaw in Warsaw, Poland, presented new data from Reva Medical's "Fantom STEMI" pilot study. The study showed procedural success and clinical utility of the Fantom bioresorbable scaffold in nine patients with acute ST-segment elevated myocardial infarction (“STEMI”) heart attacks. "Many heart atta...
Source: MDDI - October 16, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: Business Cardiovascular Source Type: news

Bard ’ s peripheral artery stent exceeds acceptable restenosis rate
In this study, a PSVR of more than 2.4 suggests greater than 50% restenosis. At the time of the analysis, 155 subjects passed their nine-month visit and were evaluated for the primary and secondary endpoints. Restenosis through nine months following the procedure was among the factors measured in the study’s primary endpoint composite. Patients will be followed through 36 months. Bard won pre-market approval from the FDA for the LifeStream covered iliac stent for treating peripheral artery disease in June 2017. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries wit...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Stents Vascular BD Clearstream Technologies crbard Source Type: news

BD ’ s Bard updates on higher restenosis rate for LifeStream covered iliac stent
In this study, a PSVR of more than 2.4 suggests greater than 50% restenosis. At the time of the analysis, 155 subjects passed their nine-month visit and were evaluated for the primary and secondary endpoints. Restenosis through nine months following the procedure was among the factors measured in the study’s primary endpoint composite. Patients will be followed through 36 months. Bard won pre-market approval from the FDA for the LifeStream covered iliac stent for treating peripheral artery disease in June 2017. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries wit...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Stents Vascular BD Clearstream Technologies crbard Source Type: news

FDA Okays Rivaroxaban Plus Aspirin for Chronic CAD, PAD FDA Okays Rivaroxaban Plus Aspirin for Chronic CAD, PAD
The rivaroxaban/aspirin combination is for the prevention of thrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 12, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

12.10.18: Not intended for U.S. and UK Media
U.S. FDA approves Bayer's Xarelto® for patients with coronary or peripheral artery diseaseXarelto, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease / Xarelto, in combination with aspirin, is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient group / Approval in the U.S. follows regulatory clearance in both Europe and Canadamehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - October 12, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA approves Bayer & #8217;s Xarelto ® for patients with coronary or peripheral artery disease (for specialized target groups only)
Xarelto, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease / Xarelto, in combination with aspirin, is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient group / Approval in the U.S. follows regulatory clearance in both Europe and Canada (Source: Bayer Company News)
Source: Bayer Company News - October 12, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA Approves XARELTO ® (rivaroxaban) to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
(Source: Johnson and Johnson)
Source: Johnson and Johnson - October 11, 2018 Category: Pharmaceuticals Source Type: news

FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
TITUSVILLE, NJ, October 11, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 11, 2018 Category: Drugs & Pharmacology Source Type: news

Managing Peripheral Vascular Disease: A Short Summary of a Long History
A look back at a decade of advances in management of peripheral vascular disease prompted this short summary of big changes. (Source: ConsultantLive)
Source: ConsultantLive - October 11, 2018 Category: Internal Medicine Authors: Gregory W. Rutecki, MD Tags: Cardiovascular Disease Hypertension Source Type: news