Medtronic (NYSE:MDT) today released new results from a clinical trial of its leadless Micra transcatheter pacing system, touting significantly reduced major complication risks compared to conventional pacing systems. The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via […]
Cardiac Implants
Medtronic teases new “extravascular” ICD system
Medtronic (NYSE:MDT) today released results from feasibility studies of its new “extravascular” EV-ICD System implantable cardioverter defibrillator designed with leads placed outside the hearts and veins, under the rib cage. The Fridley, Minn.-based medical giant touted results from the studies, which it said are the 1st to explore the novel extravascular placement, as showing the […]
ESC adds St. Jude’s CardioMems to guidelines for directed HF therapy
The European Society of Cardiology has added St. Jude Medical‘s (NYSE:STJ) CardioMems heart failure system to its guidelines as a “directed therapy management and monitoring tool for heart failure patients,” the company said today. The CardioMems device consists of a wireless sensor implanted in the pulmonary artery via catheter to directly measure pressure in the […]
Occlutech wins CE Mark for LAA occluder
Structural heart disease implant developer Occlutech said today it won CE Mark approval in the European Union for its Left Atrial Appendix occluder device designed for the minimally invasive closure of the LAA to reduce the risk of stroke in patients with atrial fibrillation. The Occlutech LAA occluder device consists of a flexible nitinol wire mesh and […]
FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote
An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune. The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis […]
Biotronik launches CardioMessenger Smart in U.S.
Biotronik said today it launched the CardioMessenger Smart portable cardiac pacing device monitor in the U.S. The CardioMessenger Smart is a portable device designed to allow pacemakers, implantable cardioverter defibrillators and insertable cardiac monitors to stay connected remotely to their monitoring physicians. “The clinical and economic benefits of remote monitoring have been well established over […]
EuroPCR 2016 Update: TAVR innovations, FFR systems in the spotlight
UPDATED May 20, 2016, with more results out of Paris. St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe. The company announced the launch and clearance at the EuroPCR meeting in Paris this week. […]
Edwards touts multi-trial heart valve data
Edwards Lifesciences (NYSE:EW) yesterday released results from 3 trials of its surgical heart valves designed for treating aortic valve disease, touting positive clinical results from studies of over 2,000 patients. Data from the trials was presented during late-breaking sessions at the American Association for Thoracic Surgery’s 96th annual meeting this week, the company said. “Edwards is […]
BioVentrix touts 1st-in-human procedure for Revivent device
BioVentrix said it successfully implanted its micro-anchor Revivent device into a 64-year-old female patient suffering from heart failure symptoms following a heart attack. The first-in-human test follows a similar successful procedure in a pre-clinical model last December. Researchers used Revivent in what it refers to as LIVE (less-invasive ventricular enhancement) a transcatheter-based procedure designed to […]
Corvia Medical lands CE Mark for heart shunt
Corvia Medical said today that it landed CE Mark approval in the European Union for its InterAtrial Shunt device for treating a type of heart failure. The IASD is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s indicated for diastolic heart […]
Biotronik launches Orsiro drug-eluting stent trial
Biotronik said today it enrolled the 1st patient in its BiostemI trial looking to compare the safety and efficacy of its Orsiro hybrid drug-eluting stent with Abbott‘s (NYSE:ABT) Xience Xpedition in treating ST-segment elevation myocardial infarction. The company is touting the trial as the largest investigator-initiated study pitting the Orsiro stent against the Xience Xpedition. The randomized, […]