Boston Scientific (NYSE:BSX) reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization. Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial […]
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Cardiac Implants | Structural Heart | Pulsed-Field Ablation
Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
LivaNova launches Perceval valve trial
LivaNova (NSDQ:LIVN) said today the 1st patient in the Persist-AVR trial of its Perceval sutureless aortic valve was implanted with the device at Nancy, France’s University of Lorraine. The company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the […]
Boston Scientific’s Synergy stent at 2 years | ACC 2016 roundup
Evolve II: 2-year data for Boston Scientific’s Synergy stent Boston Scientific‘s (NYSE:BSX) Synergy stent showed non-inferiority to its Promus Element Plus device after 12 months, according to data from the Evolve II trial presented yesterday at the annual conference of the American College of Cardiology. The Synergy stent’s bioresorbable polymer coating is designed to dissolve completely […]
FDA approves CardioFocus’ HeartLight ablation system
CardioFocus said today it won FDA premarket approval for its HeartLight endoscopic ablation system, indicated for treating drug refractory recurrent symptomatic paroxysmal AF. The approval is based on data from a 353-patient, multi-center pivotal clinical study which met the primary safety and efficacy endpoints and reported freedom from paroxysmal AF at 12 months post-procedure, the Marlborough, […]
Fire & Ice: Medtronic’s Arctic Front ablation catheter as good as BioSense Webster’s ThermoCool | ACC 2016
Results from a clinical trial presented today at the annual meeting of the American College of Cardiology showed that the Arctic Front ablation catheter made by Medtronic (NYSE:MDT) is noninferior to Johnson & Johnson (NYSE:JNJ) subsidiary BioSense Webster’s ThermoCool device in treating atrial fibrillation. The Fire & Ice study compared Arctic Front’s cryoballoon ablation technique with the […]
Medtronic touts more early data from drug-filled stent study | ACC 2016
Medtronic (NYSE:MDT) yesterday touted early data from a clinical study of its drug-filled stent aimed at winning CE Mark approval in the European Union. The DFS is built using the Fridley, Minn.-based medical device giant’s Resolute Integrity and Resolute Onyx stents, using its “continuous sinusoid” and CoreWire technologies. It’s made with a “tri-layer” wire design in which the innermost […]
Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients. Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien […]
Philips Volcano touts 5,000-patient iFR study
Royal Philips (NYSE:PHG) said today it has enrolled more than 5,000 patients in 3 clinical studies examining its Volcano proprietary instant wave-free ratio pressure measurement technology against conventional fractional flow reserve measurements. Both FFR and iFR measure differences in blood pressure through partially blocked coronary arteries to assess whether blockage is caused by a shortage […]
Medtronic launches CoreValve Evolut R trial in low-risk patients
Medtronic (NYSE:MDT) said yesterday that it launched another clinical trial for its CoreValve Evolut R replacement heart valve, aiming to win an expanded indication for low-risk patients. The 1,200-patient trial is designed for patients with less than 3% risk of dying from open valve surgery, randomized to either transcatheter aortic valve replacement with the CoreValve device or surgical aortic […]
Cardiovascular Systems to lay off 8%, reports preliminary Q3 sales beat
Cardiovascular Systems (NSDQ:CSII) said yesterday that it’s planning to lay of 8% of its workforce even as it reported preliminary fiscal 3rd-quarter sales numbers that beat both its own forecast and the consensus expectation on Wall Street. The company said it expects to post sales of $43.5 million to $44 million for the 3 months ended yesterday, roughly […]
Video: Researchers develop “bionic” heart patch
Researchers at the University of Tel Aviv had developed a proof-of-concept “bionic patch” designed to monitor and treat heart conditions in real time, according to a report from Reuters. The patch features engineered, functional tissue integrated with electronics and is designed to give doctors new options for treating myriad heart problems. Findings from the development of […]