Minimally Invasive Aortic Valve Replacement With the Lotus System

Sadra Medical out of Campbell, California just won $30 million in financing to move forward the company’s system for transcatheter replacement of aortic valves. Currently under a feasibility study in Europe, the Lotus device has already been used successfully on a 93 year old patient in Germany.

The Lotus™ Valve System is the first fully repositionable technology designed to specifically address both the disease etiology of the aortic valve and the unique requirements of a transcatheter aortic valve replacement procedure. In addition to its repositioning and self-centering features which facilitate optimal positioning of the valve, the device’s unique ability to be resheathed and retrieved provides physicians with more control over the procedure.
The Lotus™ Valve System consists of the Lotus™ Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve supported by a self-expanding nitinol stent structure, and the Lotus™ Delivery Catheter, a delivery system for guidance and placement of the Lotus Valve. The device is introduced endovascularly via the femoral artery using conventional catheterization techniques. The Lotus™ Delivery Catheter balances flexibility and support to facilitate smooth tracking through potentially challenging diseased anatomy and it is easily guided into the aortic root using a retrograde approach. The valve is intended for placement in the aortic annulus overlying the native aortic valve. The system is engineered to enable placement in a beating heart, and the valve begins to function early in the release process, minimizing systolic ejection forces.
The Lotus™ Valve does not require balloon inflation or rapid pacing of heart. The fine operator control over valve unsheathing, seating and deployment is an essential feature that aids in precision placement and helps the operator to avoid coronary obstruction and minimize contact with the mitral valve. Further, this comprehensive control of the valve until deployment provides confidence in achieving a first-time fit. Prior to releasing the Lotus Valve into its final position, the valve may be retracted into the sheath of the delivery system for repositioning and redeployment or removal if it cannot be satisfactorily positioned. The Lotus Valve features the Adaptive™ Seal, which is designed to conform to irregular surfaces of the native anatomy to minimize perivalvular leakage.

Here’s an animation demonstrating the Lotus system:

Product page: Lotus™ Valve System …
Press release: Sadra Medical Raises $30 Million Will Take Next-generation Percutaneous Aortic Valve Replacement System to Commercial Viability …