Boston Scientific Plugs TAVI Gap with CE Mark for 25 mm Lotus™

Last October Boston Scientific gained CE mark approval for its Lotus™ Transcatheter Aortic Valve Implantation (TAVI) System. That approval included 23mm and 27mm sizes, and now the company tells us it has plugged the gap with the CE marking of its new 25 mm iteration which will be made available immediately.

Background

The Lotus Valve System is not yet available in the United States so isn’t yet seen as a competitor to the offerings from Edwards Lifesciences and Medtronic on that side of the pond. In Europe though, it’s right up there, with an indication that offers a unique and effective alternative treatment for patients with severe aortic stenosis at high risk of conventional surgical valve replacement.

Compared with the first transcatheter offerings to hit the market, Boston claims the Lotus system is distinctly second generation, consisting of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve.

Its low-profile delivery system and introducer sheath are designed to enable predictable and precise placement associated with early valve function, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant.

One of its characterising features is the Adaptive Seal, a kind of skirt that is designed to minimize the incidence of paravalvular regurgitation, which has proven to be a predictor of mortality.

Now, then, the system offers the range of sizes to match its claims of precise placement, the 25mm iteration filling a clearly identified need. Just listen to what the docs say after they tried it in pre-approval evaluation.

Physician comments

“Having the 25 mm size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients,” said Dr. Nicolas Van Mieghem at Erasmus Medical Center, Rotterdam, The Netherlands.

“We have seen great results in the patients we have treated with the 25 mm Lotus Valve System,” said Dr. Sabine Bleiziffer from the German Heart Centre in Munich, Germany. “What I really like about the Lotus valve is that it provides a high level of precision during implantation, allowing me to feel in control. We look forward to treating more patients with this valve.”

“The Lotus valve design helps simplify the procedure with the ability to assess valve functionality before release,” said Prof. Dr. Peter Wenaweser from the Inselspital in Bern, Switzerland. “Adding a 25 mm valve makes sizing and valve selection even more precise.”

Company comments

“We believe the addition of the 25 mm valve size will offer our Lotus users an important treatment option for patients with severe aortic valve disease,” said Tom Fleming, vice president and general manager, Structural Heart, Boston Scientific. “Commercializing the 25 mm valve only seven months after our initial launch of the Lotus Valve System demonstrates our commitment to advancing therapies and improving patient outcomes.”

Source: Boston Scientific Corporation, PR Newswire

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