BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate […]
Cardiovascular
Medtech stories we missed this week: Dec. 29, 2017
From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory […]
Medtech stories we missed this week: Dec. 8, 2017
From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press release that it has signed its first European distribution deal with Italian company Moss […]
Boston Scientific recalls certain sizes of Eluvia, Innova stents
Boston Scientific (NYSE:BSX) has initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system, according to a document filed by the Federal Institute for Drugs and Medical Devices in Germany. The company said it was pulling these particular devices due to the number of […]
Mercator MedSystems to study its Bullfrog micro-infusion device in below-the-knee critical limb ischemia
Mercator MedSystems announced last week that it finished enrollment for a six-month trial of its Bullfrog micro-infusion device in patients with below-the-knee critical limb ischemia. The Emeryville, Calif.-based company’s 120-patient trial was designed to evaluate if Mercator’s Bullfrog device can improve blood flow and reduce the occurrence of restenosis following atherectomy-based revascularization. Mercator’s micro-infusion device […]
TCT 2017: Drug-eluting balloon achieves non-inferiority with drug-eluting stent
Researchers studying 278 patients with in-stent restenosis found that B. Braun‘s SeQuent Please paclitaxel-eluting balloon was non-inferior to Abbott‘s (NYSE:ABT) Xience drug-eluting stent when it comes to six-month minimal lumen diameter. The study’s results were touted this week at the annual Transcatheter Cardiovascular Therapeutics conference in Denver, Colorado. Researchers found that treatment with a drug-eluting […]
TCT 2017: Medtronic & OrbusNeich evaluate shortening dual anti-platelet therapy with drug-eluting stents
At this year’s Transcatheter Cardiovascular Therapeutics meeting, companies presented work comparing shortened durations of dual anti-platelet therapy with the standard 1-year regimen in patients treated with a drug-eluting stent. Among those companies were Medtronic (NYSE:MDT) and OrbusNeich. Here’s a look at what they found. Medtronic’s DAPT-STEMI trial Yesterday, investigators presented data from Medtronic’s independently-run DAPT-STEMI trial, […]
Biotronik’s Orsiro drug-eluting stent succeeds at five-year follow-up
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 […]
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 […]