Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. The designation — a first for Bloomington, Ind.–based Cook Medical — will enable priority review and better communication with FDA during the clinical trial and premarket review phases. […]
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
Medtronic touts results of cardiac resynchronization therapy trial
Medtronic (NYSE:MDT) announced today that a study showed longer lives for patients treated with cardiac resynchronization therapy (CRT). Fridley, Minn.-based Medtronic’s Reverse (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) clinical trial for those with mild heart failure (HF) found that patients whose HF stabilizes with CRT live longer, similar to those whose condition improves […]
Boston Scientific completes Preventice buy, divests BTG Pharmaceutical business
Boston Scientific (NYSE:BSX) announced that it completed its acquisition of Preventice Solutions that could be worth up to $1.225 billion. The transaction includes a cash payment of $925 million upfront with up to an additional $300 million in potential commercial milestone payments available. Accounting for the company’s approximately 22% equity stake in Preventice prior to the […]
Silk Road Medical reports losses in Q4, sales up 13%
Silk Road Medical (NSDQ:SILK) posted fourth-quarter results that missed the consensus forecast on Wall Street, citing a second wave of COVID-19 in the last quarter of 2020. The Sunnyvale, Calif.-based company reported losses of -$16.8 million, or -49¢ per share, on sales of $21.1 million for the three months ended Dec. 31, 2020, for a […]
2 deaths reported in Medtronic HeartWare recall
Medtronic (NYSE:MDT) is recalling its HeartWare HVAD pump implant kit because the device may fail to start, restart, or have a delay in restarting after the pump was stopped, the FDA announced today. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations, […]
Vascular Graft Solutions wins FDA approval for clampless proximal anastomosis
Vascular Graft Solutions today announced that it has received FDA approval for its Viola clampless anastomosis in coronary artery bypass grafting. The Viola device is designed to minimize aortic manipulation during on and off-pump coronary artery bypass grafting (CABG) to enable cardiac surgeons to perform protected, clean and dry proximal anastomosis without partial clamping the […]
The top 7 medtech CEO quotes on COVID-19, one year later
The latest earnings season has provided insights into the future of medtech in the COVID-19 landscape and what certain sectors are seeing as vaccines start to roll out. Since the start of the pandemic, 113.1 million COVID-19 cases have been reported worldwide, according to Johns Hopkins University School of Medicine. The U.S. leads the world […]
iRhythm’s revenue jumps 33% in Q4
iRhythm Technologies (NASDAQ: IRTC) reported mixed Q4 results but predicted strong sales growth in 2021. The San Francisco–based company — maker of the Zio ambulatory cardiac monitoring patch — reported a loss of –$9.7 million, or –33¢ per share, on sales of $78.8 million for the three months ended Dec. 31, 2020, nearly halving its […]
Silk Road Medical touts results of large TCAR study
Silk Road Medical (NSDQ:SILK) touted results from a comparative effectiveness study of transcarotid artery revascularization (TCAR). Results, published in JAMA Network Open, found that the availability of TCAR at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events, which are a composite of in-hospital stroke, myocardial infarction or death […]
Stereotaxis up on Street-beating Q4 results
Shares of Stereotaxis (NYSE:STXS) shot up in morning trading today after the robotic surgery company reported Street-beating Q4 results and predicted double-digit revenue growth this year. The St. Louis–based company, creator of robotic technologies for the treatment of cardiac arrhythmias, reported a loss of –$1.18 million, or –2¢ share, on sales of $6.82 million for the […]
iRhythm Zio 10 times more effective in identifying Afib, study says
iRhythm Technologies (NSDQ:IRTC) today touted study results that found its Zio device was more effective in detecting Afib than standard care. Published in JAMA Cardiology, the SCREEN-AF study showed that the use of Zio by iRhythm led to a tenfold increase in the detection of Afib when compared to patients receiving standard clinical care. One of […]