Biotronik touted long-term safety and efficacy data for its Orsiro drug-eluting stent yesterday at this year’s Transcatheter Cardiovascular Therapeutics meeting. Data from the Bioflow-II trial and the Bioflow-III registry demonstrated that Biotroniks’s device boasts strong safety and clinical performance at five years, the company reported. In the 268-patient group treated with Orsiro, 60-month data from […]
Vascular
Here’s how Amaranth Medical plans to get ahead with its bioresorbable scaffold tech
There are two ways to make a bioresorbable, drug-eluting scaffold, according to Amaranth Medical CEO Kamal Ramzipoor. “The Amaranth way, or the conventional way, which our competition is using,” he told Drug Delivery Business News. “What we’ve seen throughout the years is the conventional method has some very significant limitations. And that’s what has manifested itself into, unfortunately, […]
Reva, Biotronik tout safety data for their drug-eluting bioresorbable scaffolds
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 […]
Long-term data for Abbott’s Absorb “highlight the need for continued improvements” in BRS tech
Hours before Abbott (NYSE:ABT) presented three-year data from a pivotal trial of its Absorb bioresorbable scaffold, the FDA updated a letter to healthcare providers, writing that the device continues to show an increased rate of major adverse cardiac events and thrombosis compared to patients treated with a drug-eluting stent. “The FDA’s recommendations for health care providers […]
TCT 2017: OrbusNeich’s dual therapy stent non-inferior to Abbott’s Xience DES in 1-year follow-up
OrbusNeich touted results today from a pivotal registration study comparing its Combo dual therapy stent with Abbott‘s (NYSE:ABT) Xience stent in patients with ischemic heart disease. The trial is designed to evaluate the effectiveness of OrbusNeich’s combined endothelial progenitor cell capture and drug-eluting stent. The data showed that the device is non-inferior to Abbott’s drug-eluting […]
Elixir Medical unveils ‘bioadaptive’ metallic drug-eluting stent at TCT 2017
Interventional cardiologists have used stents to keep the heart’s coronary arteries open for decades. Transitioning from bare-metal stents to drug-eluting stents in the early 2000s brought tremendous benefits for patients. “But over the last 10 years, the technological progress and meaningful clinical improvements have plateaued,” Elixir Medical CEO Motasim Sirhan told Drug Delivery Business News. “When you stent an artery […]
Medinol wins CE Mark for EluNir drug-eluting coronary stent
Medinol said today that it won CE Mark clearance for its EluNir drug-eluting stent – a device designed with a low metal footprint and an elastomeric coating. In one 958-patient clinical study, the coronary stent had a 12-month target lesion failure rate of 5.4% and a 0% rate of late stent thrombosis, proving non-inferior to […]
FDA clears expansion of CeloNova’s nano-coated coronary stent trial
CeloNova Biosciences said today that the FDA approved an expansion of the on-going clinical trial for its Cobra PzF nano-coated coronary stent with 14-day dual antiplatelet therapy in complex patients, like people who are at a high risk of bleeding. The company touted its Cobra Reduce trial as the first randomized control trial to study […]
How slugs, snails & worms inspired Gecko Biomedical’s biocompatible sealant
The story behind Gecko Biomedical’s biocompatible sealant starts in the summer of 2009, when Boston Children’s Hospital‘s chief of cardiac surgery reached out to Jeffrey Karp about a problem he was experiencing in the operating room. Dr. Pedro del Nido told Karp, a professor of medicine at Harvard and the director of the Laboratory for […]
Surmodics goes head-to-head with Medtronic’s drug-coated balloon in pivotal trial
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 […]