Replacement Prosthesis Treats Aortic Valve Stenosis

The Lotus Valve System is a TAVR device that consists of a preloaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. The low-profile delivery system and introducer sheath are designed to enable predictable and precise placement, as well as bidirectional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant, providing physicians increased control during implantation and a more precise, predictable procedure. The system comes preloaded on a transfemoral delivery system, which is inserted through a small incision in the leg.

The Lotus Valve System also incorporates adaptive seal technology designed to minimize the incidence of paravalvular regurgitation, a proven predictor of mortality. Available in 23 mm and 27 mm sizes, the system can treat patients with aortic annulus diameters of 20–27 mm. The Lotus Valve System is a product of Boston Scientific Corporation (Natick, MA, USA), and has received the European community CE marking of approval. It is an investigational device in the United States and Japan, and is not available for sale in those countries.

“The Lotus Valve System offers patients a new, effective treatment option and provides physicians unmatched positioning and placement capabilities,” said Tom Fleming, vice president and general manager of Structural Heart at Boston Scientific. “It's the culmination of a decade of research and development and demonstrates our commitment to innovations that make a difference in the lives of patients.”

“The ability to initially position the Lotus Valve precisely and, if needed, to easily reposition or fully retrieve the valve provides the operator with remarkable control,” said Prof. Ian Meredith, MD, of Monash Medical Center (Melbourne, VIC,  Australia), and principal investigator of the REPRISE II trial. “Combined with early and often complete elimination of aortic regurgitation as observed in REPRISE II, the unique features of the Lotus Valve technology represent a significant step forward in the percutaneous treatment of eligible patients with severe symptomatic aortic stenosis.”

Aortic valve disease is dysfunction of the aortic valve, usually as a result of stenosis that produces abnormal narrowing of the aortic valve opening and reduction in blood flow. Aortic stenosis is a common problem affecting approximately three percent of the population over age 65 and five percent of people older than 75. From the onset of aortic stenosis symptoms, the average survival rate is 50% at two years and 20% at five years.

Related Links:
Boston Scientific Corporation
Monash Medical Center