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 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