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.SurModics Completes Trial Enrollment for SurVeil DCB
SurModics accomplished a huge milestone this week by completing enrollment for a pivotal trial of its SurVeil drug-coated balloon (DCB). About 446 peripheral artery disease (PAD) patients at 65 sites across the world will be evaluated in the TRANSCEND trial.
The Eden Praire, MN-based company is seeking to treat PAD in the upper leg.
Enrollment completion triggered a $10 million milestone payment from Abbott Laboratories. The agreement between the two companies was formed in February 2018 and provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB.
Pursuant to the terms of the agreement, SurMod...
Source: MDDI - August 28, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
August Is Hot with New FDA Breakthrough Device Designations
V-Wave is joining the growing list of companies that have been granted breakthrough device designation by FDA this month. The Caesarea, Israel-based company gained the designation for its interatrial shunt for heart failure.
Miniature and minimally invasive, the interatrial shunt relieves increased left atrial pressure, which in turn, decreases fluid build-up in the lungs.
“The interatrial shunt allows a small amount of blood volume from the left side of the heart to flow into the right side of the heart,†Murtaza Mogri, PhD Director, Business Development & Market Access V-Wave, tol...
Source: MDDI - August 16, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
Concept Medical Has the ‘MagicTouch’ to Treat PAD
Concept Medical just received a huge burst of speed in its quest to get its drug-coated balloon for the treatment of peripheral artery disease (PAD) commercially available in the U.S.
The Tampa, FL-based company has received breakthrough device designation from FDA for the MagicTouch PTA, a Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK).
So far, Concept Medical said MagicTouch has been performing extremely well. In the XTOSI pilot study, the majority of patients enrolled had major comorbidities (diabetes and end-stage renal failure) and the indicat...
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Omar Ford 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
FDA Eases Up on Paclitaxel Device Recommendations
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Medical device companies that sell paclitaxel-coated balloons or paclitaxel-eluting stents have been waiting to see what action FDA would take to address the late mortality signal associated with these devices. The agency provided some clarity around the issue on Wednesday that could drive a rebound in the utilization of paclitaxel devices.
Paclitaxel devices came into the spotlight in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. After a two-day meeting of the CirculatoryÂ&n...
Source: MDDI - August 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Regulatory and Compliance Source Type: news
FDA Rejects BD & #039;s Lutonix Submission for Below-the-Knee PAD
Drug-coated balloons and drug-eluting stents that use paclitaxel as the drug have been heavily scrutinized this year, which likely played a role in FDA's decision to reject  Becton, Dickinson and Company's (BD) Lutonix paclitaxel-coated balloon for below-the-knee (BTK) peripheral artery disease (PAD).
BD inherited the device through its $24-billion acquisition of C.R. Bard, a deal that closed at the tail end of 2017. FDA originally approved the Lutonix DCB in October 2014 for patients with above-the-knee PAD (the first FDA approval in the DCB category), and in 2017 the agency...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Cardiovascular Source Type: news
Smoking Creates Long-Lasting Risk for Clogged Leg Arteries
MONDAY, Aug. 5, 2019 -- Cigarette smokers have a sharply higher risk of peripheral artery disease (PAD) -- and even if they quit, that added risk can last for decades, a new study warns.
PAD narrows arteries in the leg, leading to reduced blood flow... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 5, 2019 Category: General Medicine Source Type: news
In Smokers, PAD Risk Climbs Faster Than CHD, Stroke Risks In Smokers, PAD Risk Climbs Faster Than CHD, Stroke Risks
Is smoking ' s effect on peripheral artery disease underappreciated? It was twice as strongly associated with PAD risk as with either coronary heart disease or stroke risk in a cohort study.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - July 24, 2019 Category: Cardiology Tags: Cardiology News Source Type: news
Marketing Your Medical Technology for Outpatient Use: Five Strategies for Success
Profits are shrinking at many U.S. healthcare systems. Their inpatient costs are increasing, while their admissions and revenues remain flat.
In response, organizations are shifting their care-delivery strategies away from the costly inpatient setting to more cost-effective outpatient settings. Many companies see this shift and are investing to reflect it. However, simply labeling a product for outpatient use is not enough. In today’s value-based care environment, the bar for outpatient use is even higher than that for inpatient use.
The shift in care delivery demands a shift in R&D and ma...
Source: MDDI - July 24, 2019 Category: Medical Devices Authors: Tom Dudnyk Tags: Business Source Type: news
Peripheral artery disease risk lasts 30 years after stopping smoking
The negative effects of smoking can still linger decades after quitting the habit, as a new study shows with findings that 30 years after quitting, increased risk for peripheral artery disease can persist. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 23, 2019 Category: Consumer Health News Source Type: news
Study quantifies smoking's strong link to peripheral artery disease
(Johns Hopkins University Bloomberg School of Public Health) A new study led by researchers at the Johns Hopkins Bloomberg School of Public Health found that cigarette smoking boosts the risk of peripheral artery disease, and this elevated risk can persist up to 30 years after smoking cessation. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 23, 2019 Category: International Medicine & Public Health Source Type: news
Smoking Has Long-Term Impact on Peripheral Artery Disease Risk
MONDAY, July 22, 2019 -- Both duration and intensity of smoking have a long-term impact on the risk for three major atherosclerotic diseases: peripheral artery disease (PAD), coronary heart disease (CHD), and stroke, according to a study published... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 22, 2019 Category: Pharmaceuticals Source Type: news
Risk for Leg Amputation Higher With Microvascular Disease
FRIDAY, July 12, 2019 -- Microvascular disease (MVD) increases the risk for amputation alone and in combination with peripheral artery disease (PAD), according to a study published online July 8 in Circulation.
Joshua Beckman, M.D., from the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 12, 2019 Category: Pharmaceuticals Source Type: news
Any Microvascular Disease a Risk Factor for Limb Amputation Any Microvascular Disease a Risk Factor for Limb Amputation
The risk climbs in people with microvascular disease even if it ' s in the eyes, kidneys, or nervous system, and with or without peripheral artery disease, say researchers.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - July 12, 2019 Category: Cardiology Tags: Cardiology News Source Type: news
Think the Paclitaxel Device Debate Only Impacts Cardio? Think Again
One of the most alarming facts about the ongoing debate regarding a late mortality signal associated with paclitaxel-coated devices is that this isn't the industry's first rodeo with this sort of issue.
"Some of us are having a deja vu all over again moment remembering December 2006 when we had the late stent thrombosis issue with paclitaxel- and sirolimus-eluting stents," John Hershfeld Jr, MD said during the second of a two-day FDA advisory panel meeting about the paclitaxel-coated device issue. "That was, like this situation, discovered by independent investigators and not in any way affiliated w...
Source: MDDI - June 25, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
