Feature | October 31, 2013

Boston Scientific Receives CE Mark for Lotus Valve System

TAVR device offers precise positioning and placement, offering physicians unprecedented control

heart valve repair hybrid or cath lab
October 31, 2013 — Boston Scientific Corp. has received CE mark for its Lotus Valve System, a transcatheter aortic valve replacement (TAVR) technology. This key approval offers an effective new treatment alternative for patients with severe aortic stenosis at high risk with surgical valve replacement.
 
The Lotus Valve System is immediately available to select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained. It is designed to provide physicians increased control during implantation and to help provide a more precise, predictable procedure. It is the only aortic valve device that can be assessed in its final position prior to release while maintaining the ability for the physician to reposition or fully resheath and retrieve the valve. The Lotus Valve System also incorporates Adaptive Seal technology designed to minimize aortic regurgitation.
 
"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 Ian Meredith, director of MonashHeart at Monash Medical Centre, Melbourne, Australia and principal investigator, 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."
 
Data presented at the PCR London Valves course in September demonstrated the Lotus Valve System met the primary performance endpoint for the first 60-patient cohort and was implanted successfully in all patients with no cases of severe paravalvular regurgitation. In 76.1 percent of patients, there was no corelab adjudicated paravalvular regurgitation at six months.
 
"Results from the REPRISE II trial highlight the promise behind the Lotus Valve System, especially related to avoiding moderate or severe paravalvular leaks," said Nicolas Van Mieghem, M.D., Erasmus Medical Center, Rotterdam, Netherlands. "In addition to providing a new treatment option for TAVR, the Lotus Valve has the potential to improve clinical outcomes by minimizing paravalvular leaks."
 
The Lotus Valve System comes pre-loaded on a transfemoral delivery system, which is inserted through a small incision in the leg. Available in a 23 mm and 27 mm size, the Lotus Valve System can treat patients with aortic annulus sizes from 20 mm to 27 mm. The Lotus Valve System is an investigational device in the United States and Japan, and is not available for sale in those countries.
 
For more information: www.bostonscientific.com

Related Content

Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors| June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
Sponsored Content | Videos | Structural Heart Occluders| June 16, 2016
This is an animation of how a Gore Cardioform Septal Occluder is implanted for the transcatheter closure of ASDs or P
GE Healthcare, Getinge Group, Maquet, Discovery IGS 730 angiography system, Magnus operating table, integrated, hybrid OR

GE Healthcare's Discovery IGS 730 angiography system

Technology | Hybrid OR| June 13, 2016
GE Healthcare and Getinge Group announced the U.S. launch of a new, highly flexible angiography solution for surgery,...
Inventory management, cath lab inventory management, automated inventory management
Sponsored Content | Webinar | Inventory Management| June 10, 2016
Do you find products are stocked based on intuition rather than actual utilization based on clinical demand?
TeleHealthRobotics, Tele-Robotic Ultrasound, TRUDI, robotic ultrasound

The Tele-Robotic Ultrasound for Distance Imaging (TRUDI) system uses a robotic arm so a remote sonographer can control the echo probe without the need for them to be in the same room or even be in the hospital during an exam or procedure. 

News | Cardiovascular Ultrasound| June 09, 2016
June 9, 2016 — The American Society of Echocardiography (ASE) will host Echovation Challenge 2016, a competition for
heart failure, muscle bleeding, British Cardiovascular Conference, MRI
News | Heart Failure| June 08, 2016
The amount a heart ‘bleeds’ following a heart attack can predict the severity of future heart failure, according to...
Biotronik, ORIENT trial results, EuroPCR 2016, Orsiro DES, hybrid drug-eluting stent
News | Stents Drug Eluting| June 03, 2016
Biotronik announced results establishing non-inferiority of the Orsiro hybrid drug-eluting stent (DES) to the Resolute...
News | Drug-Eluting Balloons| June 03, 2016
June 3, 2016 — Cardionovum GmbH recently announced the completion of enrollment of the RAPID trial.
radial access, transradial
Feature | Radial Access| May 27, 2016 | Dave Fornell
The use of transradial artery vascular access for percutaneous coronary intervention (PCI) in the United States has s
Overlay Init