13 Apr 2019

FDA issues ‘concerning signal’ on paclitaxel-coated devices

The FDA said in late March 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 FDA

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13 Apr 2019

DABRA Excimer Laser Atherectomy to be Presented in Key Events at Charing Cross International Symposium

Ra Medical Systems Inc., headquartered in Carlsbad, California, has scheduled its key DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) Excimer Laser Atherectomy events at the upcoming Charing Cross International Symposium in London April 16–18. Ra Medical is in Booth No. 509. These events include case and podium presentations and

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10 Apr 2019

CAN SOMEONE TELL ME WHAT A PBM REALLY DOES?

By Rachel Bluth   It was back-to-school day at the Senate Finance Committee hearing April 9. In the third of a series of hearings on rising drug prices, the senators seemed focused on getting an answer to one central question: What the heck is a pharmacy benefit manager? Pharmacy benefit managers,

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10 Apr 2019

AVINGER GETS FDA OK FOR PANTHERIS SV SMALL VESSEL ATHERECTOMY DEVICE

  The U.S. Federal Drug Administration granted Aninger’s Pantheris SV small vessel image-guided atherectomy system pre-market approval in eight months. The Pantheris SV is an extension of the Redwood City, California-based company’s lumivascular image-guided atherectomy platform, which it hopes will expand the available market for its Pantheris devices by up

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10 Apr 2019

Teleflex gets premarket OK for biomechanical MANTA Closure

  Teleflex Inc., a global provider of medical technologies for critical care and surgery, has announced that it received premarket approval from the U.S. Food and Drug Administration for the MANTA Vascular Closure Device – the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial

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10 Apr 2019

SPRY HEALTH KEEPS TIGHT FOCUS WITH THE LOOP SYSTEM

  The Palo Alto, California-based company has received FDA clearance for a wearable that can remotely monitor patients with chronic diseases, such as chronic obstructive pulmonary disease (COPD), allowing the detection of early signs of deterioration before symptoms are noticeable. Spry Health’s tight focus could have significantly beneficial implications for

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10 Apr 2019

SVS JOURNAL: EVT IS THE NEW CASH COW FOR NON-VASCULAR DOCTORS; ETHICAL ISSUES RAISED

A new report suggests that providers who are not traditionally associated with the treatment of venous disease are driving the rapid increase in endovenous therapies. A compound annual growth rate of 15 percent has been observed for minimally-invasive procedures to treat superficial venous reflux over the past decade. In the

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10 Apr 2019

LETHAL PLANS: When seniors turn to suicide in long-term care

      By Melissa Bailey and JoNel Aleccia When Larry Anders moved into the Bay at Burlington nursing home in late 2017, he wasn’t supposed to be there long. At 77, the stoic Wisconsin machinist had just endured the death of his wife of 51 years and a grim new diagnosis: throat

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09 Apr 2019

AVLS to begin receiving research abstracts APRIL 17 for 2019 Annual Congress Emerging Science

The American Vein and Lymphatic Society (AVLS) will begin accepting research abstracts for presentation at the AVLS 2019 Annual Congress on April 17. Access to emerging science in the medical field is essential for physicians to deepen clinical competence and improve their practice. The AVLS 2019 Annual Congress Emerging Science

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09 Apr 2019

 MERZ NORTH AMERICA REGAINS EXCLUSIVE DISTRIBUTION OF ASCLERA (POLIDOCANOL) INJECTION

  Merz North America Inc. has regained exclusive distribution of Asclera (polidocanol) Injection in the United States to all healthcare practitioners and phlebologists treating varicose veins, effective April 8. Also effective April 8th, AngioDynamics Inc. is no longer an authorized distributor of Asclera. All healthcare professionals will now be able

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