Boston Scientific has been awarded CE Mark approval for their Lotus Valve System, used to treat patients with aortic stenosis who are considered too high risk for invasive cardiothoracic surgery. The implant itself is a stent-mounted tissue valve prosthesis, and the delivery system and introducer sheath have a low cross-sectional profile design to allow physicians greater control during the operation.
The device is also introducing a couple unique technologies for TAVR (transcatheter aortic valve replacement) devices. It is the only aortic valve device that physicians can position, see how it’s doing, and then reposition if necessary prior to final release. It can also be removed altogether for any reason. Another new feature is the Adapative Seal which helps ensure minimal aortic regurgitation and helps reduce the chance of congestive heart failure as it becomes more efficient at pumping.
REPRISE II, a clinical trial of the Lotus, showed the device was safe and effective with a 100% implant rate and 76.1% of the patients showed no paravalvular regurgitation. Although more patients will likely require a pacemaker with the implant when compared with competing products, the minimal regurgitation is expected by Boston Sci to outweigh the downside.
Product page: Lotus Valve System…
Press release: Boston Scientific Receives CE Mark For Lotus™ Valve System…