Transcatheter mitral valve replacement is a new frontier in the cardio device field, with big legacy medical device companies including Edwards Lifesciences, Medtronic and Abbott spending hundreds of millions of dollars on companies in the space. Much different from transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) has been mostly experimental. TMVR is used […]
Cardiac Implants
NaviGate touts “excellent” valvular function at 1 year with Gate tricuspid valve
NaviGate Cardiac Structures Inc today touted that the first patient to receive its Gate tricuspid valved stent through a transjugular access procedure under compassionate use protocols has reached one year post-procedure and still maintains excellent valvular function. The procedure was performed last April at the Cleveland Clinic, the Lake Forest, Calif.-based company said. At one year, […]
Medtronic touts data from Micra pacer AV algorithm study
Medtronic (NYSE:MDT) late last week released data from a new clinical study of an algorithm used with its Micra transcatheter pacing system, touting that it has the potential to restore atrioventricular synchrony and improve cardiac function in patients with sinus rhythm and AV block. Results from the study were presented at the Heart Rhythm Society’s annual scientific […]
Investors win class certification in lawsuit against Abbott’s Thoratec
A group of Thoratec shareholders this week won a class certification in a revived suit claiming that Thoratec, now owned by Abbott (NYSE:ABT), and some of its officers hid facts about its HeartMate II heart pump’s rate of thrombosis that would have negatively affected share prices, thereby misleading investors. Investor Bradley Cooper originally brought the suit against the company […]
Medtronic touts Micra leadless pacer post-approval registry study data
Medtronic (NYSE:MDT) today released one-year results from the post-approval registry study of its Micra leadless transcatheter pacing system, touting a high implant success rate and a low complication rate. Results from the study are slated to be presented tomorrow at the Heart Rhythm Society’s annual scientific sessions conference in Boston, the Fridley, Minn.-based company said. Medtronic’s Micra […]
Abbott warns of outflow graft twisting issues with HeartMate 3
Abbott (NYSE:ABT) last Friday warned about possible issues with its HeartMate 3 left ventricular assist device over possible twisting of the outflow graft that can occur post-implant and could result in a persistent low-flow alarm, which normally signals potential safety risks including low blood flow or clotting. The Abbott Park, Ill.-based company is not recalling any […]
Medtronic extends afib clinical trial support agreement with Arca Biopharma
Arca Biopharma said today it extended a US, Canadian and European clinical trial collaboration deal with medtech giant Medtronic (NYSE:MDT) for an additional year, now slated to continue until April 2019. Through the deal, Medtronic will support clinical trial use of its monitoring devices, collection of managed atrial fibrillation burden data and managed analysis of cardiac rhythms […]
FDA approves Angel Medical System’s AngelMed Guardian cardiac monitor
The FDA this week approved Angel Medical Systems AngelMed Guardian implantable cardiac monitor system after the device had previously been rejected unanimously by an FDA advisory panel in 2016. The initial rejection came after the Tinton Falls, N.J.-based company presented partial data from its pivotal trial of the device in after having pulled the plug […]
Biotronik inks distro deal with Aziyo for CanGaroo cardiac device envelope
Biotronik inked a US-based co-distribution deal with Aziyo Biologics to distribute the company’s CanGaroo bio-envelopes designed to hold cardiovascular implantable devices, according to a release from Aziyo posted today. Silver Spring, Md.-based Aziyo Biologic’s CanGaroo bio envelope is designed to reduce the risk of device migration and erosion and simplify device removal during revisions or exchanges, […]
Abbott launches study comparing OCT to angiography in stent placement procedures
Abbott (NYSE:ABT) today announced the launch of new trial exploring long-term outcomes in patients who underwent stent implantation guided by optical coherence tomography as compared to angiography. The first patient in the trial was enrolled by Dr. Franco Fabbiocchi at Milan, Italy’s IRCCS Centro Cardiologico, the Abbot Park, Ill.-based company said. “Today, most of the world […]
FDA to launch ICD registry, update GUDID system
The FDA is slated to launch a new national registry of implantable cardiac defibrillators, according to a report from the Regulatory Affairs Professionals Society. The move comes after some reluctance from industry players around the use of unique device identifiers, according to the report. The FDA implemented a final rule in 2013 requiring UDIs on […]