Abbott (NYSE:ABT) announced today that studies support its next-generation Navitor TAVI system and its Amplatzer Amulet device. Results from the Navitor study supported recent FDA approval for the transcatheter aortic valve implantation (TAVI) system. The FDA last month approved the system for treating severe, symptomatic aortic stenosis in those at high or greater risk for […]
TAVI
Boston Scientific’s Acurate Neo2 valve performs well in studies
Boston Scientific (NYSE:BSX) announced positive outcomes from studies of its Acurate Neo2 aortic valve system. Initial outcomes from the Neo-Align study of 170 patients who underwent transcatheter aortic valve implantation (TAVI) with Acurate Neo2 using a novel implant technique to attempt commissural alignment of the prosthetic and native valves demonstrated that commissural alignment can be […]
Boston Scientific’s Acurate Neo performs well in latest trials
Boston Scientific (NYSE:BSX) touted positive results from multiple studies for its Acurate neo2 aortic valve system. Marlborough, Mass.-based Boston Scientific presented results from the investigator-initiated Early neo2 Registry and Ital-neo Registry studies at the EuroPCR 2021 meeting earlier this week, according to a news release. Results from the Early neo2 Registry of 554 patients across […]
Medtronic wins CE mark for TAVI system in low-risk patients
Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system. Evolut TAVI, now commercially launched in Europe, is now indicated for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The system’s indications in Europe now cover all risk categories for […]
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve implant by incorporating stability, predictability and […]
Why partnerships between medtech companies and doctors are so important
As new devices and technologies are being developed in the medtech industry, doctors and physicians have to learn about the devices on platforms that are different from what they know. One way to help make the healthcare provider’s transition into using new devices easier is to forge a partnership between the industry and the physician, […]
TAVI: Good early data for Keystone Heart’s TriGuard
Data from a trial of Keystone Heart‘s TriGuard anti-stroke device showed a lower rate of neurologic deficits after transcatheter aortic valve implantation, according to research presented last month at EuroPCR 2015 in Paris. The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to […]
Biotronik looks to get into the TAVI game
Biotronik today said its entry into a hot replacement heart valve market passed the safety endpoint of a 1st-in-human trial.
The German medical device giant said the Biovalve trial of its transcatheter aortic valve implant established the device’s early safety at 30 days.
TAVI: Direct Flow to put its valve up against Medtronic’s CoreValve
ACC 2015: Danish study finds TAVI safe for low-risk patients
(Reuters) — Transcatheter aortic valve implantation is safe for low-risk patients, according to a study presented at the American College of Cardiology meeting in San Diego.
Edwards CEO Mussallem hopes FDA to accelerate approvals of medical devices
(Reuters) – U.S. health regulators appear open to speeding up approvals of medical devices that currently often reach European markets three to five years ahead of being cleared in the United States, the chief executive officer of Edwards Lifesciences (NYSE:EW) said.
