Abiomed (NSDQ:ABMD) said today it entered into a corporate partnership with Boston’s Fenway Park, and will bring its Impella mobile learning lab to the stadium tomorrow. The lab will be parked at Fenway so individuals in healthcare and medical fields can learn about its Impella heart pump, which the Danvers, Mass.-based company says is the […]
Cardiac Implants
HeartWare completes enrollment in Endurance2 HVAD trial
HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system. The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said. Data from the 465-patient supplemental cohort trial will be […]
Neovasc squeaks by Q2, positive on Tiara trial
Neovasc (NASDAQ:NVCN) reported 2nd quarter sales ahead of estimates, though down from 2014 and marked by growing losses, but rallied around the progress of its Tiara transcatheter mitral valve implant feasibility trial. The company’s 30-patient Tiara 1 trial has 2 study patients implanted, in addition to 5 patients implanted through compassionate use regulations. Of the 3 compassionate […]
FDA warns on potential LVAD issues
The FDA published a safety communication today warning about issues with implantable left ventricular assist devices. The federal watchdog referenced specific issues with both approved implantable LVADs: Thoratec’s HeartMate II and HeartWare’s HVAD system. Adverse events referenced included increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s […]
Boston Scientific inks deal with Preventice
Boston Scientific (NYSE:BSX) said yesterday it inked a sales and marketing deal with cardio-focused remote patient care company Preventice Solutions. The new deal will position medical device giant Boston Scientific as Preventice’s exclusive sales and marketing representative for its cardiology-related diagnostic and monitoring offerings, the companies said. “This agreement marks an important strategic milestone for Preventice Solutions. […]
Sorin claims its new CRT-P is the world’s smallest
Sorin Group (BIT:SRN) said today it launched its Reply CRT-P cardiac resynchronization therapy pacemaker, claiming it to be the world’s smallest of its kind. The Reply CRT-P is 11.3 cc in volume, 3.7 cc smaller than Boston Scientific‘s (NYSE:BSX) Intua and 0.2 cc smaller than St. Jude Medical‘s (NYSE:STJ) Anthem CRT-P, according to their respective sites. The […]
Biotronik wins CE Mark for new MRI-safe pacemakers
Biotronik said yesterday it won CE Mark approval in the European Union for 2 next-generation MRI-safe pacemakers. The new devices are compatible with up to 3 tesla MRI scanning machines, the company said. Around 20-30% of MRI machines worldwide are 3T machines, Biotronik said, and the number of these devices is growing. “The benefits of 3 […]
Micell launches MiStent SES trial in China
Micell Technologies said today it launched a Chinese trial of its MiStent SES sirolimus eluting absorbable polymer coronary stent system used to treat coronary artery disease. The prospective, single-blind, multi-center, randomized, controlled Dessolve C trial looks to enroll 428-patients in a study comparing the company’s MiStent SES and the Tivoli bioabsorbable coated stent, which Durham, […]
Boston Scientific wins FDA nod, CE Mark for Safari2 guidewire
Boston Scientific (NYSE:BSX) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its Safari2 pre-shaped guidewire designed for placing interventional devices in the heart. The Safari2 is specifically intended for use with transcatheter aortic valve implantation or replacement procedures.. Boston Scientific’s new pre-shaped guidewire is compatible with all TAVI/R […]
Biotronik wins FDA nod, launches Itrevia CRT-D in US
Biotronik said today it won FDA premarket approval for its quadripolar Itrevia HF-T cardiac resynchronization defibrillator and launched the device in the U.S. market. The device includes a closed loop stimulation algorithm, capable of adapting heart rate in response to physiological demands independent of movement or respiration, Biotronik said. “The FDA has approved CLS as […]
Researchers 3D print hearts to improve LAA operations
Researchers in Australia are creating 3D replicas of patient’s hearts to plan out left atrial appendage closures using Boston Scientific‘s (NYSE:BSX) Watchman device, according to a new report from heartwire. Creating the 3D replica is useful in patients with complicated cardiovascular anatomy, where even advanced imaging methods can make it difficult to quantify the area […]