Hot Chocolate Could Help Ease Painful Clogged Leg Vessels
FRIDAY, Feb. 14, 2020 -- Could hot chocolate deliver relief to those suffering from the painful condition known as peripheral artery disease (PAD)? A small, new study says it's entirely possible. Though you may be picturing a steaming cup of hot... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 14, 2020 Category: General Medicine Source Type: news

Cocoa may improve lower-leg blood flow, walking in peripheral artery disease
Cocoa may help improve walking and lower-leg blood flow in adults with peripheral artery disease, according to a study published Friday in the journal Circulation Research. (Source: Health News - UPI.com)
Source: Health News - UPI.com - February 14, 2020 Category: Consumer Health News Source Type: news

Cocoa may improve leg blood flow, walking in peripheral artery disease
Cocoa may help improve walking and lower-leg blood flow in adults with peripheral artery disease, according to a study published Friday in the journal Circulation Research. (Source: Health News - UPI.com)
Source: Health News - UPI.com - February 14, 2020 Category: Consumer Health News Source Type: news

PAD Patients Often Don't Receive Evidence-Based Care From Specialty Clinics PAD Patients Often Don't Receive Evidence-Based Care From Specialty Clinics
Patients with peripheral artery disease (PAD) attending specialty clinics do not always receive evidence-based care, and supervised exercise therapy (SET), in particular, is often missed, an international registry study suggests.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 11, 2020 Category: Consumer Health News Tags: Cardiology News Source Type: news

Medtech in a Minute: SFA Competition, Check-Cap Inches Toward US Market, and More
Gore Has a New Challenger in SFA PQ Bypass is set to become the first company since 2004 to have an IDE trial for a stent to treat peripheral artery disease in the superficial femoral artery (SFA). If all goes as planned for the company, its Torus Stent Graft will compete head-to-head with W.L. Gore's Viabahn system. PQ Bypass could potentially file for FDA approval in 2021.   Should This Blood Test Be Part of the Standard Pre-Op for Most Surgeries? A common cardiac blood test done before surgery can predict who will experience adverse outcomes after most types of surgery, said researchers from Hami...
Source: MDDI - January 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

20 Private Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

20 Private Medtech Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

PQ Bypass Steps into SFA Arena to Compete Against Gore
It might be cliché to say here comes a new challenger – but in the case of PQ Bypass it’s quite true. The Milpitas, CA-based firm said it will be the first company since 2004 to have an IDE trial for a stent to treat peripheral artery disease in the superficial femoral artery (SFA). The other company to have an SFA IDE trial is W.L. Gore. The Newark, DE-based company would eventually win a nod from FDA for the Viabahn system. PQ Bypass made a major advancement in its bid to get the Torus Stent Graft on the market last week as the company reported it received approval for cov...
Source: MDDI - December 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

5 More Private Medtech Companies to Keep Tabs On
MedTech analysts continue to keep a watchful eye on the private sector. Needham & Co.'s Mike Matson recently called attention to five private medical device companies he finds interesting, adding to three previous lists the analyst published earlier this year. Matson was not the only medtech analyst keeping tabs on up and coming private companies in 2019. In January, Canaccord Genuity's Jason Mills highlighted 16 potentially disruptive medtech companies in the private sector. Here are the five companies Matson most recently highlighted. 7D Surgical...
Source: MDDI - December 16, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Leg Pain Could Spell Peripheral Artery Disease for Some
FRIDAY, Nov. 29, 2019 -- Leg pain while walking or doing other activities could be a sign of peripheral artery disease, an expert says. Peripheral artery disease (PAD) develops silently, narrowing blood vessels until a shortfall in the supply of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - November 29, 2019 Category: General Medicine Source Type: news

Not getting enough magnesium? You might be at risk of heart disease, depression
(Natural News) Being deficient in nutrients comes with serious health risks. Having low levels of magnesium, for instance, can increase your risk of cardiovascular diseases and depression. In a study published in the journal Atherosclerosis, researchers found that people with low magnesium levels are at risk of developing peripheral artery disease (PAD). When the participants... (Source: NaturalNews.com)
Source: NaturalNews.com - November 27, 2019 Category: Consumer Health News 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

Einstein Awarded $8 Million to Use Wearable Tech to Improve Detection of Leg Arterial Disease
November 21, 2019—(BRONX, NY)—Lower extremity arterial disease (LEAD) is a debilitating but under-recognized condition usually caused by fatty plaque buildup in arteries carrying blood from the heart to the legs. More commonly known as peripheral artery disease, this increasingly common condition affects more than 8 million Americans, including up to 20% of those over the age of 60, and over 200 million people worldwide. Left untreated, LEAD can result in disability, amputations, and death. (Source: Einstein News)
Source: Einstein News - November 21, 2019 Category: Universities & Medical Training Source Type: news

LimFlow Shows ‘PROMISE’ During VIVA
A firm that was labeled one of Medtech’s 16 Most Promising Private Companies by Canaccord Genuity earlier this year, has strong results from a study that will help with FDA approval. LimFlow recently announced positive six-month data from the full patient cohort in its PROMISE I early feasibility study of the Percutaneous Deep Vein Arterialization (pDVA) System. The Paris-based company presented the data during the Vascular Interventional Advances [VIVA] Conference held in Las Vegas, earlier this month. The company’s technology is used for the treatment of chronic limb-threatening ischem...
Source: MDDI - November 18, 2019 Category: Medical Devices Authors: Omar Ford 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

FDA Okays Two Stellarex DCBs for Peripheral Artery Disease FDA Okays Two Stellarex DCBs for Peripheral Artery Disease
The paclitaxel-coated balloon is now available in seen lengths to treat patients with femoropopliteal disease.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 15, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

Sky Medical Technology Nabs FDA Clearance for VTE Device
Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism. The Daresbury, England-based company said the geko device is the first muscle pump activator of its kind to be cleared by FDA for VTE prevention across all patients. Sky Medical Technology’s geko is a non-invasive battery-powered, wearable therapy device that is about the size of wristwatch. The technology is worn at the knee. Geko works by gently stimulating the common peroneal nerve, activating the calf and foot muscle pumps, re...
Source: MDDI - October 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

AngioDynamics Has Laser Focus on PAD with New Acquisition
The M&A’s just keep coming this week as AngioDynamics announced a plan acquire Eximo Medical. Latham, NY-based AngioDynamics will pick up the company for about $46 million in up-front consideration with the possibility of up to $20 million in milestones. The announcement comes a day after Lantheus Holdings revealed its intention to acquire Progenics Pharmaceuticals. Eximo has developed technology that delivers short, high-powered pulsed-laser energy in 355nm wavelength without compromising the integrity of its fiber optic cables during atherectomy procedures. The technology addresses the risk of perfo...
Source: MDDI - October 3, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Blood Flow Monitoring Device - FlowMet-R Gets FDA 510K Clearance
Laser Associated Sciences' Non-Invasive Device Disrupting the Industry IRVINE, Calif., Oct. 2, 2019 -- (Healthcare Sales & Marketing Network) -- Laser Associated Sciences (LAS), a medical device company based in Irvine, California, announced that its b... Devices, Monitoring, FDA Laser Associated Sciences, FlowMet-R, Blood Flow, peripheral artery disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 2, 2019 Category: Pharmaceuticals Source Type: news

Understanding the trends in lower-extremity amputations for diabetes and peripheral artery disease
(Source: St. Michael's Hospital News and Media)
Source: St. Michael's Hospital News and Media - September 20, 2019 Category: Hospital Management Tags: Hospital News Source Type: news

First & #039;Artificial Meniscus & #039; Wins FDA Breakthrough Device Designation
U.S. patients who continue to suffer from knee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. FDA has granted Active Implants' NUsurface meniscus implant a breakthrough device designation. The artificial meniscus device is already available in Europe and, if cleared by FDA, would also be the first artificial meniscus in the United States.  Earlier this year Active Implants gained some attention from Needham & Co.'s Mike Matson, who included the company on a list of interesting private medtech companies.&Acir...
Source: MDDI - September 19, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Source Type: news

Orchestra & #039;s Drug-Eluting Balloon Wins FDA Breakthrough Device Designation
FDA has granted a breakthrough device designation for Orchestra BioMed's Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease. The designation comes just a few months after the New Hope, PA-based announced its partnership with Terumo. The agreement included a $30 million up-front payment to Orchestra plus an equity commitment of $5 million. Virtue SEB is a novel, first-in-class drug/device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. Breakthrough d...
Source: MDDI - September 17, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Combo Antithrombotic Therapy Increases Bleeding Risk
TUESDAY, Sept. 17, 2019 -- Patients with chronic coronary artery disease or peripheral artery disease treated with the combination of rivaroxaban and aspirin face a greater risk for bleeding versus patients treated with aspirin alone, according to a... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 17, 2019 Category: Pharmaceuticals Source Type: news

Lifetime Risks for Peripheral Artery Disease Higher for Blacks
FRIDAY, Sept. 13, 2019 -- The lifetime risks for peripheral artery disease (PAD) are higher in black men and women than in whites or Hispanics, according to a study published online Sept. 10 in the Journal of the American Heart Association. Kunihiro... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 13, 2019 Category: Pharmaceuticals Source Type: news

Study: Black men have 30 percent higher risk for peripheral artery disease
The risk of developing peripheral artery disease, a condition that narrows the leg arteries, is drastically higher for non-white people, a new study shows. (Source: Health News - UPI.com)
Source: Health News - UPI.com - September 10, 2019 Category: Consumer Health News Source Type: news

FDA Has Calmed Down About Paclitaxel, but Has the Market Recovered?
Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but there does seem to be some signs of a rebound in the market. The issue was a hot topic last week at Wells Fargo Securities' annual healthcare conference. FDA  eased up on paclitaxel device recommendations in August, seven months after a meta-analysis showed an increased risk of death for patients treated with paclitaxel balloons and stents. The issue drove a market decline of about 50% and was likely a deciding factor in FDA's ...
Source: MDDI - September 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Business Source Type: news

Shockwave Gets a Little Pep in Its Step with Breakthrough Device Designation
The regulatory pathway for Shockwave Medical’s Intravascular Lithotripsy (IVL) technology just received a huge jolt from FDA. The agency granted the Santa Clara, CA-based company breakthrough device designation for the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter. The firm’s device is designed to fracture problematic calcium using sonic pressure to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle. Shockwave’s technology is being evaluated in the DISRUPT CAD III, a prospective, non-randomiz...
Source: MDDI - September 4, 2019 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Cardiovascular Source Type: news

Statins May Lower Death Risk From Artery Disease
People with peripheral artery disease (PAD) have a much lower risk of death if they take cholesterol-lowering statins as directed by their doctor, a new study reports. (Source: WebMD Health)
Source: WebMD Health - September 4, 2019 Category: Consumer Health News Source Type: news

Poor Circulation in Legs? Statin Meds Can Keep You Living Longer
WEDNESDAY, Sept. 4, 2019 -- Folks with peripheral artery disease (PAD) have a much lower risk of death if they take cholesterol-lowering statins as directed by their doctor, a new study reports. About 200 million people worldwide suffer from PAD, a... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - September 4, 2019 Category: General Medicine Source Type: news

Another Breakthrough Designation for Concept Medical
Concept Medical’s MagicTouch AVF might have the “magic touch” when it comes down to nabbing breakthrough device designations. The proposed indication for the latest breakthrough device designation is for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure. Concept Medical said its first pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon was started in Singapore in 2018. Led by Principal Investigator, Dr. Tan Chieh Suai, a multi-disciplinary team of doctors ...
Source: MDDI - September 3, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

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 29, 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
  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 w...
Source: MDDI - June 25, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent
Clinical investigators will study the safety and efficacy of this microvascular device designed to restore blood flow and reduce amputations resulting from below the knee peripheral artery disease WILMINGTON, Mass., June 24, 2019 -- (Healthcare Sales & ... Devices, Interventional, FDA Micro Medical Solutions, MicroStent, peripheral artery disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 24, 2019 Category: Pharmaceuticals Source Type: news

Stroke in Patients With Peripheral Artery Disease Stroke in Patients With Peripheral Artery Disease
How common is stroke in patients with symptomatic peripheral artery disease? Should prevention strategies differ for this high-risk group?Stroke (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 20, 2019 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news

Ra Goes the Distance with Dabra in New Clinical Study
Ra Medical is looking to get some long-term data on its laser treatment for Peripheral Artery Disease. The Carlsbad, CA-based company is conducting a clinical study that will gather data for two years, post-treatment with the Dabra Excimer Laser System. The REvascularization RateS and Clinical OUtcomes with DABRA Laser: A Long-Term 2-year Study(RESULTS)is a multi-site registry trial. It includes up to 50 U.S. hospital or office-based lab sites and 2,500 patients with Rutherford Classification 2 to 6. Each patient will receive follow-up at six-month intervals. “In my practice, we are seeing ve...
Source: MDDI - June 19, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Hot Water Soak May Help Ease Poor Leg Circulation
FRIDAY, June 14, 2019 -- Could soaking in hot water followed by light exercise work as well on peripheral artery disease (PAD) as a longer bout of exercise does? The authors of a new study suggest it could, but some PAD experts aren't... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - June 14, 2019 Category: General Medicine Source Type: news