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Biotronik

Reva, Biotronik tout safety data for their drug-eluting bioresorbable scaffolds

November 1, 2017 By Sarah Faulkner

Despite the safety concerns plaguing Abbott‘s (NYSE:ABT) Absorb device, companies developing bioresorbable scaffolds are not discouraged. This week at the annual Transcatheter Cardiovascular Therapeutics Conference in Denver, a number of companies touted the safety data coming from clinical trials of their products. Among them were Reva Medical (ASX:RVA) and Biotronik – here’s an overview of that […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: abbott, Biotronik, Reva Medical

European task force: Docs should favor drug-eluting stents over bioresorbable scaffolds

October 12, 2017 By Sarah Faulkner

Abbott

Physicians should not use bioresorbable scaffolds in place of current-generation drug-eluting stents, according to a report from the European Society of Cardiology and European Association of Percutaneous Cardiovascular Inventions. The ECS/EAPCI report says that as long as concerns remain about the increased risk of myocardial infarction and scaffold thrombosis linked with bioresorbable scaffolds, physicians should […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Abbott Laboratories, Biotronik, Boston Scientific, Elixir Medical Corporation, Reva Medical

Biotronik launches trial to test new coronary drug-eluting stent

October 10, 2017 By Sarah Faulkner

Biotronik said yesterday that it began enrolling patients in a trial designed to assess the safety and efficacy of a new coronary drug-eluting stent in de novo coronary artery lesions. The Biovitesse polymer-free device combines ultra-thin struts with a new anti-proliferative limus drug designed to stop excessive cell growth, the company reported. In September, Dr. […]

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

CIRSE 2017 Round-up: Delcath touts second-gen hemofiltration system in percutaneous hepatic perfusion

September 19, 2017 By Sarah Faulkner

Delcath Systems

Delcath Systems (NSDQ:DCTH) touted data today from a study of its second-generation hemofiltration system in patients undergoing percutaneous hepatic perfusion with melphalan hydrochloride. The New York-based company presented the results from its study at the Cardiology and Interventional Radiology of Europe annual meeting in Copenhagen, Denmark. The investigational product, an injectable melphalan hydrochloride for use with […]

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Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Oncology, Pharmaceuticals, Wall Street Beat Tagged With: Biotronik, Boston Scientific, Delcath Systems Inc.

Biotronik’s Orsiro drug-eluting stent tops Abbott’s Xience in study

August 28, 2017 By Sarah Faulkner

Biotronik's Orsiro

Biotronik said today that its Orsiro drug-eluting stent beat Abbott‘s (NYSE:ABT) Xience DES in a trial comparing the target lesion failure rates of both devices. The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: abbott, Biotronik

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

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

Biotronik expands DCB line with CE Mark for Passeo-18 Lux

January 26, 2016 By Fink Densford

Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries. The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval […]

Filed Under: Drug-Device Combinations Tagged With: Biotronik

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