Navigation Links
Second-generation TAVI device -- Lotus Valve -- shows good performance in REPRISE II
Date:5/23/2013

22 May 2013, Paris, France: The Lotus Valve, a second-generation transcatheter aortic valve implantation (TAVI) device, was successfully implanted in all of the first 60 patients in results from REPRISE II reported at EuroPCR 2013, which showed good device performance and low mortality at 30 days.

"First generation TAVI devices provide significant clinical benefit, but there are opportunities for improvement," explained lead author Ian Meredith, Director of MonashHeart, Southern Health and Professor of Medicine, Monash University, Melbourne, Australia. He suggested that these include controlled deployment, simple, precise and atraumatic aortic/ventricular repositioning, no or trivial paravalvular leakage and lower complication rate.

The Lotus Valve System has been designed to address these issues. The valve is pre-attached to the delivery system, which has a simple handle design, and functions early in deployment for controlled, precise positioning. It is fully retrievable and can be repositioned and has an adaptive seal designed to minimise paravalvular leak.

REPRISE II prospectively evaluated the safety and performance of the Lotus Valve System for TAVI in symptomatic patients with severe calcific aortic stenosis considered high risk for surgical valve replacement. Reporting results for the first 60 patients, Meredith told the conference, "Successful valve implantation was achieved in all patients." The primary endpoint for device performance mean aortic valve pressure gradient at 30 days compared to a performance goal of 18mmHg was met. Mean aortic gradient decreased from 47.5+17.2mmHg before the procedure to 11.3+5.2mmHg at 30 days. At the same time effective orifice area increased from 0.6+0.2mmHg to 1.7+0.4mmHg.

"Results showed successful valve implantation in all 60 patients, meeting the primary device performance endpoint," Meredith said. "Importantly, the rate of moderate or greater aortic regurgitation decreased from 18% at the baseline study to 1.9% (one patient) at thirty-day follow up. More than 80% had either no or trivial aortic regurgitation at 30 days," he reported. He pointed out that the very low rate of moderate or greater aortic regurgitation was ten-folder lower than seen in previous trials with other systems, describing this as 'a monumental improvement.' The mortality rate was low 1.7% at 30 days.

"Valve repositioning and retrieval was performed successfully in all cases when required. And there was no embolisation, ectopic valve deployment or TAV-in-TAV," he added. Patients suffered negligible aortic regurgitation, while other clinical event rates were consistent with those reported for other valves. "These findings suggest the Lotus Valve may be a valuable addition to the armamentarium for the treatment of severe aortic stenosis," he concluded.

Commenting on the implications of the study findings, Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland, said, "An important factor is that this is a truly repositional device. And it is exciting that the rate of moderate to severe aortic regurgitation is so low."


'/>"/>

Contact: Isabelle Uzielli
iuzielli@europcr.com
33-612-233-492
European Society of Cardiology
Source:Eurekalert

Related medicine news :

1. Second-generation CT scanner substantially reduces radiation exposure
2. Docs Use 3-D Printer to Create Lifesaving Airway Device for Infant
3. Children’s National to Host Symposium on Medical Device Development
4. Walkingspree Expands Device Options with Fitbit to Increase Member Engagement in Corporate Wellness Programs
5. Post-approval TAVI registry shows high rates of device success at 1 year
6. Access MediQuip and WellPoint Renew and Expand National Contract for Implantable Medical Devices
7. New Device May Show Doctors More of the Colon
8. Sleep Apnea Devices Market to reach $19.72 Billion by 2017 - New Report by MarketandMarkets
9. Mississippi Woman’s Injuries Allegedly Caused by Ethicon Inc.’s Transvaginal Mesh Device; Parker Waichman LLP Files Lawsuit
10. PolyU Researchers Develop Novel Brain Training Device to Reconnect the Brain and Paralyzed Limb After Stroke
11. Robotic Surgery Update: Intuitive Surgical Issues Urgent Medical Device Warning Notification
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of Family Medicine's ... President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his retirement. Dr. ... 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming the role ...
(Date:10/13/2017)... Ill. (PRWEB) , ... October ... ... Edwardsville School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer ... healthcare professionals on guideline updates for the primary prevention of cardiovascular diseases ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term ... long-term care insurance companies have a waiver for care if the client has a ... when the family pays for care, is often waived, so the benefits from their ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids ... Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, ... run is geared towards children of all ages; it is a non-competitive, non-timed event, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, ... Development, has been awarded a contract by the Center for Medicare and Medicaid ... to accelerate the enterprise use of Agile methodologies in a consistent and high ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... 2017  Caris Life Sciences ® , a leading ... of precision medicine, today announced that St. Jude Medical ... Alliance™ (POA) as its 17 th member. Through ... Crosson Cancer Institute will help develop standards of care ... profiling, making cancer treatment more precise and effective. ...
(Date:10/10/2017)... 2017   West Pharmaceutical Services, Inc. (NYSE: ... drug administration, today shared the results of a study ... the intradermal administration of polio vaccines. The study results ... May 2017 by Dr. Ondrej Mach , Clinical ... Organization (WHO), and recently published in the journal ...
(Date:10/4/2017)... , Oct. 4, 2017  According to the Centers for Disease ... end of October . PhysicianOne Urgent Care is helping communities across ... Westchester, NY , by offering no-cost* flu shots through the end ... mandated by certain health insurance regulations. ... The best time to get a flu shot is by the end ...
Breaking Medicine Technology: