OrbusNeich said today it launched a Chinese trial of its Combo dual-therapy coronary stent designed to repair vessel injury and regenerate endothelium. The 436-patient randomized, non-inferiority trial has enrolled its 1st patient, the Hong Kong-based company said, and will compare the Combo stent’s effectiveness against Lepu Medical‘s Nano stent for up to 5 years. “We […]
Cardiac Implants
Indian diamond cutting industry gets into stents
Western Indian diamond cutting businesses are beginning to develop coronary stents, producing cheaper copies of stents made by market leaders, according to a report from Bloomberg Business. The companies, such as Surat-based Sahajanand Medical Technologies, are using existing laser-cutting technology necessary for diamond cutting to cut the metal tubes used in stents, according to the report. […]
Thoratec wins CE Mark for HeartMate PHP
Thoratec (NSDQ:THOR) said today it won CE Mark approval in the European Union for its HeartMate percutaneous heart pump. Approval was based on data from the 1st 30 patients enrolled in its Shield I CE mark trial, the Pleasanton, Calif.-based company said. Data from all 50 patients in the study is slated to be presented later this […]
Biotronik launches CRT in women study
Biotronik said last week it enrolled the 1st patient in its Biowomen study investigating the difference in cardiac resynchronization therapy response in men and women to understand if women respond better to the treatment. The trial seeks to enroll 247 patients of each gender over 2 years, with a 1-year follow-up and results expected in 2018, the […]
Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015. The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said. “As a producer of superior […]
UPDATE: Medical societies update stroke guidelines
A bevy of cardiac medical societies updated their guidelines for stroke treatment yesterday to take into account new devices and technology, including left atrial appendage occlusion devices, stent retrievers and thrombectomy devices. The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions have updated their guidelines to include the benefits of left […]
DoJ closes Abiomed Impella 2.5 investigation
Abiomed (NSDQ:ABMD) said today that the U.S. Department of Justice has closed an investigation into the marketing of the company’s Impella 2.5 heart pump without taking any enforcement action. The investigation began in October 2012 when Danvers, Mass.-based Abiomed said it was informed that the U.S. Attorney’s Office of the District of Columbia had initiated […]
TAVI: Medtronic wins patent spat with doc inventor
Medtronic (NYSE:MDT) last week won a patent infringement dispute over its CoreValve aortic valve replacement with inventor Dr. Troy Norred, according to legal filings. The U.S. Patent & Trademark Office’s Patent Trial & Appeals Board found that 16 of Norred’s claims were unpatentable, upholding Medtronic’s challenge to the patent, PTO records show. The patent board ruled that […]
Medtronic wins FDA nod, launches Advisa SR MRI-safe pacer
Medtronic (NYSE:MDT) said today that it won FDA approval for its Advisa SR MRI-safe SureScan single-chamber pacemaker, and that it is launching the device in the U.S. The device will allow MRI scans of any region of the body as long as it is used with MRI-safe SureScan leads, the Fridley, Minn.-based company said. “MRI is […]
Sorin touts Freedom Solo aortic valve data
Sorin Group (BIT:SRN) said today that data from a 1-year study of its Freedom Solo stentless pericardial aortic valve showed positive safety and efficacy results. The 251-patient study looked at individuals in North America with aortic valve disease who are implanted with the device, the Milan, Italy-based company said. Results showed a mean reduction in gradient […]
CardiAQ Valve touts TMVI procedure
CardiAQ Valve Technologies said yesterday that it successfully implanted its 2nd generation transcatheter bioprosthetic mitral heart valve. The procedure was performed in Tor Vergata Hospital in Rome, Italy on a 72-year-old male suffering from severe mitral regurgitation who was ineligible for alternate treatments, the Irvine, Calif.-based company said. “These untreatable patients are the reason I founded […]