Abbott (NYSE:ABT) said today it launched a new Quartet quadripolar left ventricular lead designed for cardiac resynchronization therapy pacemakers and defibrillators. The newly launched quadripolar LV lead features a double bend shape which the Abbott Park, Ill.-based company said will aid in patient optimization in combination with its MultiPoint pacing and SyncAV technology, according to […]
Cardiac Implants
ISHLT 2017: Medtronic touts thoracotomy study for Heartware HVAD
Medtronic (NYSE:MDT) this week presented results from the HVAD Lateral thoractomy study of its HVAD heart pump system in patients with end-stage heart failure, touting high survival rates and freedom from stroke. The study aimed to explore the use of the HVAD system delivered through a less-invasive thoracotomy procedure in patients with end-stage heart failure […]
Heart Societies update guidelines to support cardiac monitors for syncope patients
Medtronic (NYSE:MDT) said today that new guidelines from the American College of Cardiology, the American Heart Association and the Heart Rhythm Society now recommend the use of cardiac monitors for patients with syncope. The updated guidelines for patients with syncope, or unexplained fainting, was published online in the Journal of the American College of Cardiology, Circulation […]
BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, expected to be available to select US heart centers this summer. “We are very grateful for […]
Fibrosis: How to prevent it in medical device implants
Massachusetts Institute of Technology (MIT) and Boston Children’s Hospital researchers have discovered a way to prevent fibrosis from forming around medical device implants by blocking certain cells. The body’s immune system usually attacks implanted medical devices that are used for drug delivery, sensing or tissue regeneration. Defense cells in the body try to isolate the […]
ACC 2017 Roundup: Abbott touts reduced HF rehospitalizations in MitraClip study
The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as news comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19. Abbott touts reduced HF rehospitalizations in MitraClip study Abbott (NYSE:ABT) released 1-year outcomes from the largest study to-date of real-world experiences […]
Medtronic wins expanded FDA indication for Melody TPV
Medtronic (NYSE:MDT) said today it won extended FDA approval for its Melody transcatheter pulmonary valve, now indicated for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed. The Fridley, Minn.-based company touted the Melody TPV as the 1st transcatehter pulmonary valve to win such an indication from the federal watchdog. “Unlike other transcatheter […]
Medtronic wins FDA nod for next-gen Linq ICM
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection. The Linq ICM with TruRhythm Detection offers exclusive algorithms which the Fridley, Minn.-based company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the […]
7 medtech stores we missed this week: March 10, 2017
The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal […]
Medtronic logs CMS reimbursement win for Micra TPS
Medtronic (NYSE:MDT) said today it won coverage from the US Centers for Medicare & Medicaid Services for its Micra transcatheter pacing system. The Micra won reimbursement through Medicare’s policy of Coverage with Evidence Development, the Fridley, Minn.-based company said. At 1/10th the size of a conventional pacemaker, or roughly the size of a large vitamin, […]
MicroPort, undaunted by price caps, enters India’s stent market
MicroPort has entered the Indian market only days after the country’s National Pharmaceutical Pricing Authority imposed a price cap on coronary stents. The Shanghai-based company said its Firehawk Rapamycin target eluting coronary stent system was successfully used in a procedure in Mumbai earlier in the month, marking the 1st time the device saw use in […]