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
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
PARIS & CAESAREA, Israel, May 22, 2013 /CNW/ - 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.
(Logo: http://photos.prnewswire.com/prnh/20130522/614227 )
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
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
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
DEFLECT-I results demonstrate great promise and value of cerebral
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.
SOURCE: Keystone Heart
For further information:
Mr. Shuki Porath, President and CEO