From stents to TAVR, Stanton Rowe has built a medtech legacy out of accomplishing the seemingly impossible. Here are three lessons from his career. Stanton Rowe has played a major role in two of the top medtech innovation success stories of recent decades: stents and transcatheter valve replacements. Listening to him speak at DeviceTalks West […]
Cardiac Implants
Medtronic logs wins in overcharging lawsuit, defibrillator case fees
Medtronic (NYSE:MDT) logged a series of legal wins this week after a federal judge dismissed a whistleblower lawsuit against the medtech titan and the U.S. Supreme Court declined to review a bid over legal fees in a long-running patent spat, upholding Medtronic’s victory from April last year. In a lawsuit brought against Medtronic, Cavallino Consulting alleged […]
Abbott gains on Morgan Stanley upgrade, touts MR conditional FDA labeling
Abbott (NYSE:ABT) shares have risen approximately 1.3% after the company received an upgrade from a Morgan Stanley analyst and won updated MR-conditional labeling from the FDA for two of its cardiac pacing devices. The share price rise came after Morgan Stanley analyst David Lewis yesterday lifted the price target for the company from $60 to $67, […]
Study: Legacy pacers, ICDs found safe for 1.5T MRI scans
Pacemakers and implantable cardioverter defibrillators not marked as MRI-safe could still be mostly safe to use during imaging sessions with 1.5T MRI machines, according to a new study reported on by Healio. Results from the study were recently published in The New England Journal of Medicine. In the prospective, nonrandomized study, researchers aimed to explore […]
Medtronic wins FDA nod for Azure remote monitoring equipped pacers
Medtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology. The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual […]
Corvia Medical launches Interatrial Shunt Device heart failure trial
Update: Corrected from previously mislabeled ‘interarterial’ to ‘interatrial’ shunts Corvia Medical said today it launched the Reduce LAP-HF II clinical trial of its transcatheter Interatrial Shunt Device designed to treat heart failure as it seeks FDA approval of the device. The Tewksbury, Mass.-based company said the 1st patient in the trial was enrolled by Dr. Rami Kahwash […]
TCT 2017: Boston Scientific touts lowered hemorrhagic stroke rate, cost for patients in Watchman studies
Boston Scientific (NYSE:BSX) today released combined 5-year outcomes data from both the Prevail and Protect-AF study of its Watchman left atrial appendage closure device, touting it as a safe and effective an alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation. Five-year data from the Prevail study was published online today in the Journal […]
TCT 2017: Edwards touts cost savings in Sapien 3
Edwards Lifesciences‘ (NYSE:EW) yesterday released data from an economic study of its Sapien 3 transcatheter aortic heart valve in intermediate risk patients, touting lower total one-year costs with the valve compared to surgical aortic valve replacements. The Irvine, Calif.-based company said the economic analysis was the first-of-its-kind to report on patients who are at an intermediate […]
TAVR: Boston Scientific’s Acurate Neo, Edwards’ Sapien 3 show similar results at 30 days
Outcomes from transcatheter aortic valve replacement procedures with both Boston Scientific‘s (NYSE:BSX) Acurate Neo and Edwards Lifesciences‘ (NYSE:EW) Sapien 3 have been found to be similar at 30 days, according to a new study reported by Healio. Results from the trial were published in the journal JACC: Cardiovascular Interventions, according to the report. The study explored […]
Edwards Lifesciences slides on Q3 sales, earnings misses
Edwards Lifesciences (NYSE:EW) missed the mark with its third-quarter sales and earnings, despite posting healthy, double-digit increases to both the top and bottom line, sending share prices down today in after-market trading. The Irvine, Calif.-based implantable heart valve maker posted profits of $170.1 million, or 79¢ per share, on sales of $821.5 million for the three […]
Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 […]