Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon. The 446-patient trial is designed to compare the company’s SurVeil device to Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon as a treatment for peripheral artery disease in the upper leg. “Based on the preclinical and early feasibility study […]
Vascular
Reva Medical launches Fantom in Switzerland with first implant of bioresorbable scaffold
Reva Medical (ASX:RVA) has expanded its commercial operations into Switzerland, the company said today, with the first implant of its Fantom bioresorbable scaffold. The scaffold is made from Reva’s tyrosine-derived, radiopaque polymer, rendering Fantom visible under fluoroscopy – a characteristic that is unique to Reva’s product. Fantom also sports 125 micron struts, which have held up […]
European task force: Docs should favor drug-eluting stents over bioresorbable scaffolds
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 […]
Biotronik launches trial to test new coronary drug-eluting stent
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. […]
India pulls an about-face on Abbott’s Xience Alpine stent
India’s Department of Pharmaceuticals has stopped Abbott (NYSE:ABT) from pulling its Xience Alpine drug-eluting coronary stent from the market. The move is a reversal from the National Pharmaceutical Pricing Authority’s decision last month to allow Abbott to withdraw the device over a one-year period. Last week, the DoP said it invoked powers described in the Drug […]
SteadyMed requests meeting with FDA over rejected application for drug-device combo
Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent. SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the […]
VIVA 17 Round-up: Medtronic touts real-world data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference. The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study. Data from the In.Pact Global study showed a 83.3% rate of freedom from clinically-driven target […]
Report: Abbott still looking to pull Xience DES from Indian market
Abbott (NYSE:ABT) is still looking to pull its Xience Alpine drug-eluting stent from the Indian marketplace after the country’s regulatory body set significant price caps on stents earlier this year, according to an Indian Economic Times report. The company reportedly approached India’s National Pharmaceutical Pricing Authority looking to withdraw the Xience stent yet again due to caps, along […]
Japan approves Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfare for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The […]
Biotronik’s Orsiro drug-eluting stent tops Abbott’s Xience in study
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 […]