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. Get the full story at our sister site, Drug Delivery […]
Drug-Eluting Stents
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 […]
Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety
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 […]
Biotronik touts Orsiro data at Japanese conference
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 […]
Meril’s bioresorbable, drug-eluting vascular scaffold
Meril Life Sciences has developed a drug-eluting, bioresorbable vascular scaffold that the body can slowly degrade and wash away. The company’s MeRes100 is made of biodegradable polymers, PLLA and PDLLA. Sirolimus, a commonly-used immunosuppressant found in drug eluting stents, is embedded in the scaffold’s coating. The company designed the struts of the device to be just […]
Micell begins MiStent clinical trial in Japan
Micell Technologies said today that it began its Dessolve J randomized, double-blind study comparing its MiStent SES sirolimus eluting absorbable polymer coronary stent to the Xience V everolimus eluting coronary stent in patients with coronary artery disease. The Durham, N.C.-based company touts its device as a bare-metal stent coated in crystalline drug, sirolimus, and an absorbable polymer, […]
OrbusNeich launches Combo Plus stent
OrbusNeich said today that it launched the latest version of its dual-therapy stent, the Combo Plus, featuring an antibody biological coating designed to promote vessel healing in patients with complex coronary artery disease. After the stent is implanted, the biological coating captures endothelial progenitor cells and kicks off formation of an endothelial layer. A coating of bioabsorbable polymer […]
Japan OKs Medinol stent trial
Medinol said yesterday that Japanese regulators approved a clinical trial of its Elunir drug-eluting stent that it plans to add to an ongoing U.S. trial of the device. The thin-strut, ridaforolimus-eluting Elunir stent (previously known as Bionir) features an elastomeric coating that’s designed to be more flexible than prior-generation polymer coatings. Last month, Medinol presented 1-year […]
PAVmed partners with Boston institutions for antibiotic-eluting ear device
PAVmed Inc. (NSDQ:PAVMU) said today that it inked an exclusive licensing agreement with academic institutions to develop and commercialize antibiotic-eluting resorbable ear tubes based on an aqueous silk technology designed by the institutions. The licensing deal includes agreements with Tufts University, Massachusetts Eye & Ear Infirmary and Massachusetts General Hospital, who developed the aqueous silk technology. As […]
Svelte Medical wins CE Mark for Direct coronary stent
Svelte Medical Systems said today that it received CE Mark approval in the European Union for its Direct sirolimus-eluting coronary stent. The stent uses a coating of sirolimus and a natural, amino acid-based polyesteramide bioresorbable drug carrier. Direct stenting minimizes the use of pre-dilation balloons, lessening the cost and time of stent procedures. Direct Rx is specifically […]
Akesys, Elixir Medical tout 1st implant for Prava bioresorbable peripheral stent
Akesys Medical and Elixir Medical Corporation said today that it implanted its 1st Prava sirolimus eluting bioresorbable peripheral scaffold for the treatment of blockages in the superficial femoral artery. The scaffold was developed to keep the large artery in the thigh open and restore blood flow to the leg and resorb into the body, making […]