CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amsel Medical Corporation today announced First-In-Man clinical use of the Amsel Occluder Device (AOD)1 at NYU Langone Medical Center, NY. The AOD2 was utilized during a variety of vascular surgical cases to ligate and occlude target vessels. AOD performance goals were met and clinical reaction was positive. Additional use of the AOD is pending. The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Arnold Miller, MD, Founder and President of Amsel Medical Corporation commented, “We are thrilled to have reached First-In-Man clinical use of the Amsel Occluder Device. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel, advancing our technique beyond the current limitations of standard ligation clips. This simply applied device is the equivalent of the secure suture ligature, which will prevent loosening or slippage. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder Device is cleared for commercial distribution.
About the NYU Langone Medical Center
NYU Langone Medical
Center is one of the premier academic medical centers in the United
States, located in New York City, New York, United States, affiliated
with New York University.
Amsel Medical Industry Exhibit at the 2017 Veith Symposium
Amsel
Medical Corporation will be presenting the Amsel Occluder Device at the
2017 Veith Symposium, NY, from November 14 through November 18, Booth
407. The company anticipates strong commercial and clinical interest in
the Amsel Occluder Device.
About the 2017 Veith Symposium
The VEITHsymposium provides
Vascular Surgeons and other Vascular Specialists with a five-day
conference on the most current information about new developments in
clinical practice and relevant research. Beginning Tuesday, the
symposium offers over 900 fast-paced presentations on what is new and
important in the treatment of vascular disease. Important updates and
reevaluations, as well as the latest significant advances, changing
concepts in diagnosis and management, pressing controversies and new
techniques, agents and diagnostic modalities will be presented.
Previous Announcements
On September 25, 2017, Amsel Medical
Corporation announced Clearance of a 510(k) Pre-Marketing Notification
by the US Food and Drug Administration for the Low-Profile Amsel
Occluder Device.
On November 28, 2016, Amsel Medical Corporation announced Presentation of “A Novel Mechanical Closure Device for Left Atrial Appendage Orifice and Closure of Right Atrial Incision” at the International Conference for Innovations in Cardiovascular Systems (ICI) Meeting 2016, Israel.
On October 27, 2015, Amsel Medical Corporation announced Filing of 2nd 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Amsel Occluder Device.
On February 2, 2015, Amsel Medical Corporation announced Clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Amsel Occluder Device.
On July 25, 2014, Amsel Medical Corporation and the Mayo Clinic Announced Signing of a Patent License Agreement
On May 20, 2014, Amsel Medical Corporation announced that it had successfully completed filing of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Amsel Occluder Device.
About the Amsel Occluder Device
The Amsel Occluder Device is
designed to easily and securely close blood vessels (veins or arteries)
as well as tubular structures during open surgical procedures. The Amsel
Occluder Device is intended for use in open general surgery procedures
on tubular structures or vessels wherever a metal ligating clip is
indicated and within the size range of 2.0mm to 7.0mm diameter. The
Amsel Occluder Device employs a proprietary mechanical design that
enables a vessel clamp to be introduced during open surgery. The Amsel
Occluder Device transfixes the target vessel with the clamp to provide
secure closure.
About Amsel Medical Corporation
Amsel Medical Corporation, a
development stage medical device company, founded in 2011, is developing
The Amsel Occluder Device intended for simple and secure vessel or duct
closure. The company has operations in Cambridge, MA, and Tel Aviv,
Israel. The Amsel Occluder Device addresses an estimated 31 million3,4
annual US surgical procedures where vessel closure is required.
Publications
Miller A, Lilach N, Botero-Anug A, Willenz U,
and Miller R: Comparison of a Novel Secure Transfixing Blood Vessel
Occluder with the Hemoclip in the Porcine Model. Journal of Surgical
Research 2017;209: 211 – 219.
Miller A, Lilach N, Miller R. and Kabnick L: A Novel, Simple, and Secure, Percutaneous Vessel Occluder for the Treatment of Varicose Veins. J. Vasc Surg; Venous and Lymphatic Disease 2017; 5:114-20.
L. Kabnick and A. Miller. Ultrasound-placed clips will make CHIVA more widely applicable. Vascular and Endovascular Challenges Update. BIBA Publishing. Ed. Roger M Greenhalgh 2016; 529-534.
1 Patents pending
2 On February 2, 2015,
Amsel Medical Corporation announced its first Clearance of a 510(k)
Pre-Marketing Notification by the US Food and Drug Administration for
the Amsel Occluder Device. Subsequently, on September 25, 2017, Amsel
Medical Corporation announced its second Clearance of a 510(k)
Pre-Marketing Notification by the US Food and Drug Administration for
the Amsel Occluder Device.
3 CDC/NCHS National Hospital
Discharge Survey, 2010
4 Company Estimates
