Keystone Heart’s TriGuard(TM) Cerebral Protection Device Receives CE Marking
CAESAREA, Israel, September 9, 2013 /PRNewswire/ –
- CE Marking for the TriGuard(TM) device, devised to minimize the risk of brain damage during TAVR, enables commencement of commercial use - Recent data demonstrates considerable reduction of new brain lesion volume during protected TAVR procedures performed with the TriGuard medical device
Keystone Heart, a leader in the development of cerebral protection devices for
interventional cardiology and cardiac surgery procedures, announced today that its
TriGuard(TM) Cerebral Protection Device has received CE Marking, enabling the company to
commercially market the TriGuard [http://www.keystoneheart.com/products ] in Europe and
other territories. The CE marking recognises the conformity of the TriGuard device with
the relevant directive of the European Community.
The CE marked 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(TM) accommodates most
anatomical variations of the aortic arch and uses a Nitinol(R) frame and mesh – flexible
and atraumatic, yet robust and sturdy.
Cerebral function is the essence of quality of life. Its preservation throughout
medical procedures is a key component to procedural success and patient care. Dr. Andreas
Baumbach, Consultant Cardiologist at University Hospitals Bristol, UK and honorary Reader
in Cardiology at the University of Bristol: “TriGuard is the most sophisticated cerebral
embolic protection device currently available.
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(TM) Cerebral Protection Device, compared
with historical data on unprotected TAVR procedures. The clinical data
[http://goo.gl/8BF8wS ] shows that Maximum Total Lesion Volume was 95% smaller and Average
Total Lesion Volume was 57% smaller when compared with historical references.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 (AVR) 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 and that
TriGuardTM may provide such protection during TAVR and other cardiovascular procedures.
The TriGuard Device is not yet commercially available in the USA.
About Keystone Heart [http://www.keystoneheart.com ]
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,
surgical valve replacement, 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
Keystone Heart is dedicated to advancing patient care through innovative technology
and clinical research. Clinical studies with the TriGuard(TM) Cerebral Protection Device
(TAVR procedures) are currently ongoing in Europe, Canada and Brazil.
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, Keystone Heart is funded by OrbiMed
Advisors LLC and OrbiMed Israel Partners. The Company holds and maintains a comprehensive
IP portfolio and is ISO certified.
Contact: Mr. Shuki Porath, President and CEO firstname.lastname@example.org Tel: +972-4-615-8000 http://www.keystoneheart.com
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SOURCE Keystone Heart