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Vascular

More trouble for United’s Remodulin

April 4, 2017 By Sarah Faulkner

United Therapeutics

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled yesterday that the claims of United Therapeutics‘s (NSDQ:UTHR) patent, which covers Remodulin, are unpatenable due to obviousness. SteadyMed (NSDQ:STDY) challenged the patent in October last year. The patent, No. 8,497,393, relates to the process to purify prostacyclin derivatives, including treprostinil, which is […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

Reva Medical wins CE Mark for Fantom bioresorbable scaffold

April 4, 2017 By Sarah Faulkner

Reva Medical

Reva Medical (ASX:RVA) said yesterday that it won CE Mark approval in the European Union for its Fantom sirolimus-eluting bioresorbable coronary scaffold. The Fantom scaffold is the San Diego, Calif.-based company’s 1st commercial product. Reva said it plans to begin selling the product in Europe this quarter. “CE Mark approval for Fantom is a major milestone for […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Abbott Laboratories, Biotronik, Elixir Medical Corporation, Reva Medical

Biotronik touts doctors’ survey responses for Magmaris drug-eluting scaffold

March 30, 2017 By Sarah Faulkner

Biotronik touts doctors' survey responses for Magmaris drug-eluting scaffold

Biotronik touted data today from its Magnesium 1,000 program, which provided doctors with an early post-market opportunity to evaluate the company’s new resorbable Magmaris magnesium scaffold. More than 98% of physicians reported that the scaffolds successfully deployed, according to the data, and that it performed well compared to the leading polymeric scaffold, Biotronik said. The program […]

Filed Under: Drug-Device Combinations, Featured, Vascular, Wall Street Beat Tagged With: Biotronik

Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety

March 27, 2017 By Sarah Faulkner

Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Vascular, Wall Street Beat Tagged With: Boston Scientific

Intact Vascular finishes patient enrollment for angioplasty clinical trial

March 23, 2017 By Sarah Faulkner

Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular, Wall Street Beat Tagged With: C.R. Bard, Intact Vascular, Medtronic

Biotronik touts Orsiro data at Japanese conference

March 20, 2017 By Sarah Faulkner

Biotronik's Orsiro

Biotronik touted data today from the BioFlow-IV study of its Orsiro hybrid drug-eluting stent at this year’s Japan Circulation Society congress. The company’s study enrolled 579 patients with de novo coronary lesions and randomized them to receive either the Orsiro stent or Xience stent. After 12 months, the researchers confirmed non-inferiority of its stent, based […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: Biotronik

BTG’s Ekos device targets pulmonary embolism with drug, ultrasound wave combo therapy

March 13, 2017 By Sarah Faulkner

BTG's Ekos device targets pulmonary embolism with drug, ultrasound wave combo therapy

Each year, pulmonary embolisms kill more people in the U.S. than AIDs and breast cancer combined, according to BTG (LON:BTG). Venous clots in the legs or arm break off and travel through a patient’s circulatory system, eventually getting trapped in the lung and blocking the flow of blood. In some cases, this strains the heart’s ability to […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: BTG, Massachusetts General Hospital

Medtronic launches DCB clinical trial for below-the-knee peripheral artery disease

March 9, 2017 By Sarah Faulkner

Medtronic

Medtronic (NYSE:MDT) said today that it launched a clinical trial to evaluate the use of its In.Pact paclitaxel-coated percutaneous transluminal angioplasty balloon catheter in patients with below-the-knee peripheral arterial disease. The company treated its 1st patient in the In.Pact BTK study, performing the procedure on a patient with critical limb ischemia. “The 1st patient enrollment in […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: Medtronic

Study evaluates drug-device combo therapy for deep vein thrombosis

March 6, 2017 By Sarah Faulkner

Study evaluates drug-device combo therapy for deep vein thrombosis

A National Institutes of Health-sponsored study found that most patients with deep vein thrombosis should be treated with anticoagulant drugs alone, without a procedure-based intervention. However, the same study showed that a minimally-invasive catheter-director therapy, pharmacomechanical catheter-directed thrombolysis, provided greater initial pain relief and could prevent disability in DVT patients. The research was presented today […]

Filed Under: Clinical Trials, Featured, Research & Development, Vascular Tagged With: Boston Scientific, BSN Medical, Genentech, Medtronic, National Institutes of Health, Society of Interventional Radiology

Elixir Medical’s DeSyne stent tops Medtronic’s Endeavor after 5 years

February 28, 2017 By Sarah Faulkner

Elixir Medical‘s novolimus-eluting stent, DeSyne, outperformed Medtronic‘s (NYSE:MDT) zotarolimus-eluting stent, Endeavor, according to long-term data from Elixir’s Excella II trial. The study enrolled 210 patients with 2 or more de novo lesions in 2 different epicardial vessels. Researchers randomly assigned patients in a 2:1 ratio to the novolimus-eluting stent or the zotarolimus-eluting stent. The device emits a low […]

Filed Under: Clinical Trials, Featured, Vascular, Wall Street Beat Tagged With: Elixir Medical Corporation, Medtronic

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