SAN FRANCISCO & CAESAREA, Israel–(BUSINESS WIRE)–InSeal Medical Ltd.,
developer of percutaneous vascular closure devices for large bore punctures,
today announced the successful treatment of three patients with its
investigational intravascular large bore puncture closure device. InSeal aims
to solve a significant surgical limitation in cardio-vascular procedures by
providing physicians with the first device to percutaneously seal large bore
punctures in blood vessels from the inside. The results were described today at
the Transcatheter Cardiovascular Therapeutics 2011 scientific symposium.
“We are excited by the positive patient outcomes
observed in the first clinical study of our next generation vascular closure
device of large bore punctures,” said Avi Penner, PhD, Chief Executive Officer
of InSeal Medical. “This feasibility study is an important milestone for the
company, and the data will be included in the clinical evidence required to
support a CE approval of the InSeal vascular closure device expected in 2012.”
In the clinical trial, two patients aged 92 and 53 underwent
full percutaneous transcatheter aortic valve replacement (TAVR) using an 18
French-sized large bore catheter. A third patient aged 82 received full
percutaneous endo-vascular aneurysm repair (EVAR) using a 21 French-sized large
bore catheter. In all three procedures, patients received the experimental
InSeal Medical percutaneous vascular closure device, avoiding the need for
current standard surgical cut-down procedures or complex suturing techniques.
The InSeal closure device achieved a complete acute sealing
in each patient with no further bleeding or hematoma at the access site.
Twenty-fours following the procedure, the trials patients began to ambulate
and ultrasound testing revealed normal blood vessel flow. Patients were discharged
from the hospital within 48 hours and no complications were reported through 30
days of follow-up.
“Having treated several hundred patients needing
transcatheter aortic valve replacement and endovascular aneurysm repair, I am
excited to use an innovative device that could significantly advance minimally
invasive cardio-vascular repair and improve patient outcomes,” said Eberhard
Grube, MD, the trials principal investigator and a professor of medicine at
the University of Bonn, Germany. “I look forward to participating in the
ongoing clinical development program.”
“We are very pleased to have successfully completed the
first human procedures in the world with InSeals novel device,” said Alexandre
Abizaid, MD, Chief of Coronary Interventions at the Institute Dante Pazzanese
of Cardiology in Sao Paulo,
Brazil, where
the procedures were performed. “Given our extensive experience with
cardio-vascular repair and understanding the limitations of commercially
available devices, we believe that this investigational device has the
potential to address a significant unmet clinical need – a minimally invasive
alternative for patients requiring transcatheter aortic valve replacement or
endo-vascular aneurysm repair.”
The InSeal closure device was delivered into the access
artery through large bore sheaths used in TAVR and EVAR procedures. The device
is deployed across the puncture, with a biodegradable membrane patching the
site. In the trial, delivery and deployment of the InSeal closure device took
less than two minutes. The experimental device does not need sutures.
Transcatheter aortic valve replacement and endo-vascular
aneurysm repair are two of the largest and fastest growing fields in
cardio-vascular intervention. Transcatheter aortic valve replacement is an
endovascular procedure to replace a diseased aortic valve. Aortic stenosis is a
common problem affecting approximately two percent of people over age 65 and
four percent of people over age 85. Endo-vascular aneurysm repair is an
endovascular procedure to treat abdominal or thoracic aortic aneurysms,
balloon-like enlargements of the aorta which, if left untreated, may rupture
and cause death. Approximately 4.5 million people are living with abdominal
aortic aneurysms in the developed world and each year 600,000 new cases are
diagnosed.
About InSeal Medical Ltd.
InSeal Medical Ltd. (Caesarea, Israel http://www.InSealMedical.com/) develops and manufactures
percutaneous vascular closure devices for sealing of puncture site following a
treatment involving large bore sheath. The Companys first product in
development is an intravascular closure device, which supports the closure of
14-21Fr punctures in vessels of 6-10mm in diameter. InSeal Medical Ltd. is a
fully owned subsidiary of E-Pacing Inc. and is backed by Polaris Venture
Partners (Waltham,
MA http://www.polarisventures.com/).
