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

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
Overlay Init