New Clinical Data Presented at EuroPCR Demonstrates that TriGuard Reduces Brain Lesion Volume during TAVR

PARIS and CAESAREA, Israel, May 22, 2013 /PRNewswire/ --

• New clinical data presented from the DEFLECT-I study demonstrates that Keystone Heart's TriGuard™ Cerebral Protection Device reduces brain lesion volume during TAVR (Transcatheter Aortic Valve Replacement) procedures when compared to historical data.
• Keystone Heart Scientific Advisory Board announces consensus on the importance of preserving brain reserve
• Awareness rising regarding the importance and need for cerebral protection during cardiovascular procedures to minimize brain damage

Cerebral function is the essence of quality of life. Its preservation throughout medical procedures is a key component to procedural success and patient care. New scientific data presented at the annual EuroPCR Congress in Paris heightens the spreading understanding and recognition that protecting the brain and preserving brain reserve is an important goal of TAVR and other cardiovascular procedures.  

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The first report on the DEFLECT-I clinical trial was presented today at EuroPCR, during the Hot-Line - First-in-man in Valvular Heart Disease session by Dr M. Mullen, MD, the PI of the study. The TriGuard device is designed to minimize the risk of brain damage associated with cardiovascular procedures and was used to filter the embolic material from brain circulation during TAVR. The results demonstrate an impressive reduction of new brain lesion volume during TAVR when performed with the TriGuard™ Cerebral Protection Device when compared to unprotected procedures (historical data):

• Maximum single lesion volume in DEFLECT-I was 17 x smaller than the average in the reported literature (0.39 vs. 6.45 cm³), representing a 94% reduction.
• Maximum total lesion volume in DEFLECT-I was 95% smaller than the maximum total lesion volume in reported studies (3.94 vs. 70.3 cm³).
• Average (mean) single lesion volume in DEFLECT-I was 65% smaller than the average of reported historical data (0.12 vs. 0.34 cm³), and average total lesion volume was 57% smaller than reported average total lesion volume in reported historical data (0.7 vs. 1.64 cm³).  

In addition, the brain protection by TriGuard™ was safe, with no device related adverse events, had no interference with TAVR procedure, and performed optimally covering all three cerebral branches in 87% of the cases throughout valve replacement.
TriGuard™, the only embolic protection device designed to cover all aortic cerebral branches, is fashioned to accommodate various anatomical variations of the aortic arch.

Keystone Heart's presence at EuroPCR, Europe's largest professional meeting specializing in interventional cardiovascular medicine, was greeted with great interest.  Focus on cardiovascular procedure related brain damage, clinically evident and silent stroke, and potential preventative measures was emphasized in additional sessions, as well as in non-affiliated scientific presentations throughout the course and congress.

Keystone Heart's Scientific Advisory Board Meeting was held adjacent to EuroPCR.  Participating key opinion leaders reached unanimous agreement on a number of issues:

• Stroke is a devastating adverse event after cardiovascular procedures
• Systemic therapy is highly unlikely to prevent strokes related to dislodgement of calcified material and valve particles
• Mechanical protection such as filters or deflection devices should be incorporated into the procedures to protect the brain from ischemic insults
• DEFLECT-I results demonstrate great promise and value of cerebral protection

Dr Jeffrey Moses, MD, Columbia University, NY

"The issue of stroke is one of the key areas of development for enhancing procedural safety in TAVR and other invasive treatments in cardiology. The preliminary data from the TriGuard MRI study points to this technology as a potential solution to this important issue"

The TriGuard Cerebral Protection Device is an investigational device and not commercially available.

About KeystoneHeart
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 damage associated with cardiovascular procedures. The Company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, atrial fibrillation ablation and other structural heart procedures. Novel devices are designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to preserve brain reserve while performing these procedures.

Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. Clinical studies with the TriGuard™ Cerebral Protection Device (TAVR procedures) are currently ongoing in Europe, Canada and Brazil with impending CE Mark.

Keystone Heart collaborates with renowned interventional cardiologists, cardiac surgeons and neurologists.

The Company's management has extensive experience in the fields of interventional cardiology and medical devices.

Founded in 2004 and headquartered in Israel, the Company recently moved to a new location in the Caesarea Business Park, to accommodate the growing team and facility.

Keystone Heart is funded by OrbiMed Advisors LLC and OrbiMed Israel Partners. The Company (previously known as SMT Research & Development) holds and maintains a comprehensive IP portfolio and is ISO certified.

Contact:
Mr. Shuki Porath, President and CEO  
[email protected] 
Tel:  +972-4-615-8000

http://www.keystoneheart.com/

SOURCE Keystone Heart