Navigation Links
TriGuard Cerebral Protection Device Shows Reduction in Stroke Rate and Improvement in Patients' Neurological Outcomes in TAVR Procedures
Date:5/18/2016

CAESAREA, Israel and PARIS, May 19, 2016 /PRNewswire/ -- EuroPCR -- Keystone Heart has announced that a pooled analysis of three prospective and comparable clinical studies of patients undergoing TAVR in US and Europe, further corroborates that TriGuard™ protection significantly reduces stroke rate, lowers CNS infarction and reduces total lesion volume, without adversely impacting the safety of the TAVR procedure.

The aim of the analysis was to evaluate the safety and effectiveness of the TriGuard™ HDH embolic deflection device compared to no protection. This was done in a pooled analysis of three prospective and comparable clinical studies of patients undergoing transcatheter valve implantation (TAVR) in the US and Europe. Dr. Alexandra J. Lansky (Division of Cardiology, Yale School of Medicine and Yale Cardiovascular Research Group, New Haven, CT, USA) presented the analysis earlier at EuroPCR, during the late breaking trials session on new valvular interventions and enabling technologies.

TriGuard(TM) Cerebral Protection Device shows reduction in stroke rate and improvement in patients' neurological outcomes in TAVR procedures. TriGuard(TM) is designed to provide full coverage to all brain territories during TAVR and other cardiovascular procedures.
TriGuard(TM) Cerebral Protection Device shows reduction in stroke rate and improvement in patients' neurological outcomes in TAVR procedures. TriGuard(TM) is designed to provide full coverage to all brain territories during TAVR and other cardiovascular procedures.

The patient level data was pooled from a total of 142 patients undergoing TAVR with TriGuard™ protection (N=59) vs. no protection (N=83). The data was pooled from three trials (DEFLECT I, DEFLECT III and Neuro TAVR) evaluating neurologic complications with and without cerebral protection during TAVR. All three trials mandated pre-discharge diffusion weighted MRI (DW-MRI) and performed serial neurologic assessments using the same methods and core laboratories.

Key results were as follows:

  • TriGuard protection significantly reduced in hospital VARC2 defined stroke (0% vs. 6.0%, p=0.05)
  • TriGuard protection significantly reduced stroke rate defined by worsening NIHSS (National Institutes of Health Stroke Scale) with DW-MRI lesions (0% vs. 19%, p=0.002)
  • TriGuard protected patients showed higher absence of CNS infarction (28% vs. 8%, p=0.008)
  • Total lesion volume was reduced significantly with TriGuard vs. no protection (315+620mm3 vs. 511+893mm3, p=0.04)
  • None of the TriGuard protected patients had worsened NIHS score, while 17.1% of the patients without protection had worsened NIHS score (p=0.001)

These clinically meaningful outcomes, clearly demonstrate the importance of using TriGuard, and the potential consequences of unprotected procedures. 

Keystone Heart's TriGuard™ is the only cerebral protection device specifically designed to provide full coverage to all aortic arch takeoffs. The CE marked TriGuard™ Cerebral Protection Device is not yet commercially available in the USA.

About Keystone Heart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures.

The Company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other cardiovascular procedures. The TriGuard product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to preserve brain reserve while performing these procedures.

Headquartered in Israel, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The Company's management has extensive experience in the fields of interventional cardiology and medical devices.

Contact:
Mr. Shuki Porath, President and CEO  
info@keystoneheart.com 
Tel:  +972 4 615 8000
www.keystoneheart.com

Photo - http://photos.prnewswire.com/prnh/20160518/369170  
Logo - http://photos.prnewswire.com/prnh/20160518/369169LOGO

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/triguard-cerebral-protection-device-shows-reduction-in-stroke-rate-and-improvement-in-patients-neurological-outcomes-in-tavr-procedures-300271156.html


'/>"/>
SOURCE Keystone Heart
Copyright©2016 PR Newswire.
All rights reserved


Related medicine technology :

1. New Clinical Data Presented at EuroPCR Demonstrates that TriGuard Reduces Brain Lesion Volume during TAVR
2. Flowonix Medical Inc. and Cerebral Therapeutics, LLC Announce Exclusive Agreement for Drug Delivery to Brain
3. Il Collegio Internazionale di Neuropsicofarmacologia (CINP) chiede ai governi di arginare la preoccupante indisponibilità di nuovi farmaci da destinare al 10% della popolazione mondiale affetta da patologie cerebrali
4. MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of Its New Dual-Layer Stent For Cerebral Aneurysm Flow Diversion
5. Passavant Area Hospital Bolsters Already Stringent Cleaning Protocols for Added Patient Protection
6. Statement from the Patients Alliance for Drug Safety Protections on the Need for Restricted Distribution Systems for High-Risk Medicines
7. Global Market Study on Hearing Protection Devices: Stringent Safety Regulations and Increasing Demand for Reusable Earplugs to Drive the Market, Persistence Market Research
8. Pharmacy - Pill Dust - Patient Protection: Madigan Patient Safety - Product Innovation Foundation Announces New Patented Product That Eliminates Dangers Related to Compromised Prescription Medication
9. Global Neuroprotection Market Report 2015 - 500 Products Have Been Investigated for Neuroprotective Effects
10. Studies Show Respiratory Volume Monitoring May Offer Better Protection for Women in Labor and Obese Patients
11. Online Catalog Update - Includes Over 50 Top OEMs and Over 600 Models for Power Protection of Laboratory Instruments
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/13/2017)... --  OrthoAtlanta has been named the official orthopedic and ... for the 2018 College Football Playoff (CFP) National Championship to ... in Atlanta, Georgia . OrthoAtlanta is proud ... participating in many activities leading up to, and including the ... ...
(Date:9/12/2017)... N.J. , Sept. 12, 2017  Consumer reviews on the ... Hearing as the number one company for hearing aids, ranking ... and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high ...
(Date:9/9/2017)... 2017 ... coming to Washington DC ... Tuesday, September 12 th – Monday, September 18 th .The Brain ... MRI brain scans to the public.Where:  BTF,s Mobile ... 501 K Street NW, Washington, D.C.What:BTF brings its nationwide initiative, the Road ...
Breaking Medicine Technology:
(Date:10/13/2017)... , ... October 13, 2017 , ... PurhealthRX , ... Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize ... providing a CBD form that can be easily incorporated into liquid products, while reducing ...
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... DevOps and Agile Software Development, has been awarded a contract by the Center ... Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
Breaking Medicine News(10 mins):