News | September 09, 2013

TriGuard TAVI Embolic Protection Device Receives European Approval

September 9, 2013 — Keystone Heart, a company in the development of cerebral protection devices for interventional cardiology and cardiac surgery procedures, announced its TriGuard cerebral protection device has received CE mark, enabling the company to commercially market the TriGuard in Europe and other territories.

The TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during transcatheter aortic valve replacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports. The TriGuard accommodates most anatomical variations of the aortic arch and uses a nitinol frame and mesh.

The preservation of cerebral function throughout medical procedures is a key component to procedural success and patient care. Dr. Andreas Baumbach, consultant cardiologist at University Hospitals Bristol, United Kingdom, and honorary reader in cardiology at the University of Bristol, said "The device has the potential to become a routine preventive measure in TAVI and other cardiovascular procedures associated with embolic lesions. European approval of the TriGuard device is an important advancement in patient care."

New scientific data presented at EuroPCR demonstrated a significant reduction of new brain lesion volume during TAVR using TriGuard, compared with historical data on unprotected TAVR procedures. The clinical data shows that maximum total lesion volume was 95 percent smaller and average total lesion volume was 57 percent smaller when compared with historical references.

The medical community is witnessing heightened focus and scrutiny on cerebral injury concurrent with cardiovascular procedures, and research on possible preventative measures and devices to protect against brain injury has increased. Data from the PARTNER A study show nearly twice as many strokes in the TAVR group compared with the surgical aortic valve replacement group at 30 days, the majority of strokes being peri-procedural and within the first 2 days. In addition, newer "next-generation" TAVR devices have so far have apparently failed to reduce TAVR-related risk of stroke. These data affirm that protecting the brain is an important goal during TAVR.

The TriGuard device is not yet commercially available in the United States.

For more information: www.keystoneheart.com

Related Content

BioTrace Medical's Tempo Lead Shows Stability and Safety in Real-World Performance
News | Leads Implantable Devices| June 20, 2017
BioTrace Medical Inc. announced that the company’s Tempo Temporary Pacing Lead was featured in an oral presentation and...
heart valve regurgitation seen on an echocardiogram, cardiac ultrasound, from ASE study
News | Cardiovascular Ultrasound| June 16, 2017
June 15, 2017 – While much attention has been focused on ways to lower heart disease-related injuries and deaths, the
Mitral Valve regurgitation showed on an echocardiogram, cardiac ultrasound

Mitral valve regurgitation showed on an echocardiogram. Image from Toshiba.

News | Heart Valve Technology| June 15, 2017
June 15, 2017 — 4C Medical Technologies Inc., a developer of minimally invasive therapies for structural heart diseas
Sponsored Content | Videos | Heart Valve Technology| June 14, 2017
A discussion with Rebecca Hahn, M.D., FASE, director of interventional echocardiography and professor of medicine at
FDA clears Claret Medical Sentinel embolic protection device for TAVR
Feature | Heart Valve Technology| June 09, 2017
June 5, 2017 – The U.S.
Sapien 3 valve for VIV (valve in valve) procedures cleared by FDA
Feature | Heart Valve Technology| June 06, 2017 | Dave Fornell
The U.S. Food and Drug Administration (FDA) has granted market clearance for aortic and mitral valve-in-valve...
LivaNova Announces Positive Data for Perceval Sutureless Valve at AATS 2017
News | Heart Valve Technology| May 31, 2017
LivaNova PLC recently announced the presentation of data from multiple studies demonstrating the safety and...
News | Guidewires| May 30, 2017
A Canadian cardiologist has published a report in the journal Eurointervention describing how he used a Canadian-...
Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve
News | Heart Valve Technology| May 24, 2017
May 24, 2017 — Late-breaking data presented at EuroPCR 2017 demonstrating excellent clinical outcomes for...
Overlay Init