TAVI Archives - Medical Design Sourcing

Data backs Abbott Navitor, Amulet heart implants

The Navitor system. [Image from Abbott’s website]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 open-heart surgery.

Data also demonstrated the benefits of the Amplatzer Amulet left atrial appendage (LAA) occluder, according to a news release. It offers immediate and complete closure of the LAA for patients with AFib at risk of stroke.

Abbott presented both studies at the annual Cardiovascular Research Technologies (CRT) meeting in Washington, D.C.

The findings reinforce the importance of continued advancements in minimally invasive technology that offer hope to patients with debilitating heart conditions,” the comp…

Boston Scientific’s Acurate Neo2 valve performs well in studies

Acurate Neo2 [Image from Boston Scientific]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 achieved safely, effectively and quickly.

Data showed that 97% of patients had no significant misalignment (80% none, 17% mild, 1.2% moderate and 1.8% severe) and the average alignment time of 92 seconds had a minimal impact on procedure duration, according to Boston Scientific. Post-procedure and 30-day safety events were consistent with expected TAVI complication rates, while small manipulations of the delivery system in the ascending aorta did not adversely impact safety outcomes.

The company also reported new findings from…

Boston Scientific’s Acurate Neo performs well in latest trials

[Image from Boston Scientific]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 12 European centers showed a 1.3% post-operative moderate/severe paravalvular leakage (PVL) rate, which was lower than the rate observed in previous studies of the device. Mild and none/trace PVL rates registered at 33.3% and 65.4%, respectively.

Meanwhile, the study revealed a 6% permanent pacemaker implementation (PPI) rate, a 2.1% in-hospital stroke rate, a 1.3% mortality rate at 30 days, as well as excellent hemodynamics, according to Boston Scientific. Results demonstrated that the Acurate neo2 device was associated with significantly…

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 severe aortic stenosis patients.

Clinical data from a global, randomized trial that evaluated three valve generations against surgical valve replacement (SAVR) in more than 1,400 patients revealed that TAVI is an effective treatment for low-risk patients, improving 30-day quality-of-life scores compared to SAVR.

Additionally, Evolut displayed superior hemodynamic performance with lower mean aortic valve gradients and larger effective orifice areas compared to surgery at one year.

Medtronic engineered Evolut with a self-expanding nitinol frame that confo…