Edwards Lifesciences (NYSE:EW) said today that it received CE Mark approval for expanded use of its Sapien 3 transcatheter aortic valve implantation (TAVI) system. The expanded use if for treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 TAVI is the first transcatheter heart valve system to win […]
Edwards jumps on Q3 sales & earnings beat, raised outlook
Edwards Lifesciences (NYSE:EW) shares jumped during the pre-market hours today on third-quarter results that topped the consensus forecast. The Irvine, Calif.-based heart valve replacement pioneer posted profits of $274.7 million, or $1.30 per share, on sales of $1.09 billion for the three months ended Sept. 30, for a 21.6% bottom-line gain on sales growth of 20.7%. […]
The top 10 medical disruptors of 2020
For the past 17 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Michael Roizen, emeritus chief wellness officer. “Healthcare is ever-changing and we anticipate that these […]
Valfix Medical pulls in $1m for dual heart valve repair-replacement device
Valfix Medical this week filed an SEC Form D reporting that it sold more than $1 million in an equity offering. The Tel Aviv, Israel-based biotech company’s new notice completed its first sale on August 22 and does not intend for the equity offering to extend beyond one year, according to the filing. The total […]
Edwards Lifesciences to put $100m into Costa Rica expansion
Edwards Lifesciences (NYSE:EW) is slated to add a $100 million expansion and 500 new jobs by the end of 2020 in an effort to expand its operations in Costa Rica, according to the Costa Rican Investment Promotion Agency. The Irvine, Calif.-based company established cardiac device manufacturing facilities in Cartago in 2016, announcing a plan to add […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
4C Medical pulls in $8m
4C Medical Technologies secured more than $8 million in an equity offering it hopes will reach the $20 million mark. The Maple Grove, Minn.-based company raised nearly $8.2 million in the offering, with $11.8 million remaining to be sold, according to an SEC Form D filed today. Forty-five unnamed investors have contributed to the offering. […]
TCT 2019: Boston Scientific slides on Acurate Neo TMVR trial miss
The Acurate Neo replacement heart valve being developed by Boston Scientific (NYSE:BSX) failed to show non-inferiority in a head-to-head comparison with the Sapien 3 valve made by Edwards Lifesciences (NYSE:EW), according to study data released at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. The 739-patient Scope I study randomized increased-risk patients to either Acurate Neo […]
Medtronic wins FDA approval for Evolut Pro+ valve
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for Evolut Pro+, the latest iteration of its transcatheter aortic valve replacement device. Last month, the FDA granted approval to TAVR devices in patients at low risk from open valve replacement surgery, including the Evolut Pro line and competing devices made by Edwards […]
TAVR technique cuts pacemaker implantation rate
According to a new study, a new approach to self-expanding transcatheter aortic valve replacement could minimize the risk of permanent pacemaker implantation. The patient-specific approach was used in analyzing nearly 250 patients with severe aortic stenosis who underwent TAVR to look at factors contributing to PPMI, according to Medscape. The study was published by lead […]
Foldax touts FIH procedure for Tria polymer heart valve
Foldax today announced first-in-human use of its Tria heart valve in an FDA early feasibility study for the treatment of aortic valve disease. The procedure was performed July 30 at Beaumont Hospital in Royal Oak, Mich. The patient is “doing well and has been discharged,” Beaumont chief of cardiovascular surgery Dr. Marc Sakwa said in […]
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