Boston Scientific has received CE mark for its new 25 mm Lotus Transcatheter Aortic Valve Implantation ( TAVI ) System, complementing the currently available 23 mm and 27 mm valve sizes.
The study has demonstrated that the Lotus Valve System delivered sustained safety and effectiveness outcomes out to six months, with only 1.1% of patients having moderate paravalvular aortic regurgitation as assessed by an independent core laboratory.
No severe cases occurred.
The Lotus Valve System offers a unique and effective alternative treatment for patients with severe aortic stenosis at high risk of conventional surgical valve replacement. It is a differentiated second-generation TAVI technology, consisting of a pre-loaded, 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 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.
Rapid pacing is not required. The device also features a unique Adaptive Seal designed to minimize the incidence of paravalvular regurgitation, which has proven to be a predictor of mortality.
Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart. Aortic valve stenosis is the process of thickening and stiffening in the valve, which can result in an abnormal narrowing of the aortic valve opening and reduction in blood flow. Aortic stenosis is a common problem affecting approximately 3% of the population over the age of 65 and five percent of people older than 75.
From the onset of symptomatic aortic stenosis, the average survival rate is 50% at two years and 20% at five years. ( Xagena )
Source: Boston Scientific, 2014