RALEIGH, N.C., April 17, 2021 /PRNewswire/ -- Contego
Medical, Inc., a leading developer of innovative cardiovascular
devices, today announced receipt of CE Mark approval for the
Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation
Balloon System with Integrated Embolic Protection (Neuroguard IEP
System).
The patented Neuroguard IEP System contains a novel,
next-generation nitinol stent, a pre-positioned post-dilation
balloon and an integrated microembolic filter with 40 μm pores. The
closed cell stent is designed to achieve optimal performance across
radial strength, vessel coverage and flexibility, additionally
featuring a unique asymmetric hourglass design that is flared at
both ends to facilitate wall apposition in tortuous anatomy. The
integrated filter is designed to capture both macro- and
micro-emboli during the entire procedure. The Neuroguard IEP
System is indicated for adult patients with clinically significant
carotid artery stenosis requiring stenting.
The Neuroguard IEP System was first evaluated in the PERFORMANCE
I clinical trial. The study was conducted in nine European sites
and included 67 patients with one year follow-up. The overall
success rate was 100% with a stroke and death rate of 0% at 30
days1.
"CE Marking of the Neuroguard IEP System is an important
milestone for Contego Medical and allows us to bring the remarkable
safety and performance benefits of the Neuroguard stent to patients
in Europe," said Ravish Sachar,
M.D., CEO and Founder of Contego Medical. "We anticipate launching
the product in select countries as well initiating a post-marketing
clinical study in the coming months."
Stacy Enxing Seng, Venture
Partner, Lightstone Ventures, and Contego Medical Board Chair
commented "Receipt of CE Mark approval for the Neuroguard IEP
System is a significant achievement for the Contego Medical team
and represents a multi-year investment in innovative product
development and high-quality clinical research. I believe that the
Neuroguard IEP System has the performance and ease of use to become
the standard of care in the treatment of carotid artery
disease."
About Contego Medical
Contego Medical, Inc. is a medical device company dedicated to the
development of novel medical devices for cardiovascular and
peripheral vascular procedures. The company's Integrated Embolic
Protection (IEP) platform, which combines embolic protection and
treatment into one device, is designed to simplify catheter-based
procedures and improve patient outcomes.
In the United States, the
Neuroguard IEP System is an investigational device, limited by
United States law to
investigational use.
Neuroguard IEP and the Contego Medical logo are registered
trademarks of Contego Medical, Inc. The Neuroguard System is
covered by U.S. patents 9,968,472 and 10,932,929 and European
patent EP 3,367,967. Additional US and Foreign patents pending.
1 LINC 2020