Amsel Medical Receives Clearance of an FDA 510(k) Pre-Marketing Notification for Amsel Endo Occluder

Amsel Medical Corporation has announced clearance of a Pre-Marketing Notification (510(k)) by the U.S. Food and Drug Administration (FDA) for its Amsel Endo Occluder. The Pre-Market Notification is the third 510(k) clearance¹ received by the company for its family of Amsel Occluder Devices.²
 
The Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and tubular (ductal) structures. The device is a mechanical occlusion clip delivered through a fine needle that when deployed transfixes the target vessel while clamping it shut. The Amsel Endo Occluder device is an endoscopic ligating clip applier and clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2 mm to 7 mm diameter.
 
Arnold Miller, M.D., founder and president of Amsel Medical Corporation, commented, “We are thrilled to expand the Amsel Occluder family of single-use, site-specific vascular control devices into the endoscopic and minimally invasive surgery market with this recent Pre-Marketing Notification (510(k)) by the U.S. Food and Drug Administration. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel or duct. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder Device is cleared for commercial distribution.”
 
Conventional minimally invasive surgical systems includes techniques such as laparoscopy and endoscopy. Laparoscopy is a minimally invasive surgical procedure which is used to examine the internal organs inside the abdomen.³ Endoscopy allows both operations on more fragile patients, notably the elderly, and the treatment of more complex diseases, such as cancer. Other benefits of endoscopy include reduced post-operative pain and risks of complications, rapid healing, lighter anesthesia and a shorter period of hospital stay. Surgery, interventional radiology, and advanced endoscopy have all developed minimally invasive techniques to effectively treat a variety of diseases to bring about a positive impact on patients’ postoperative outcomes. The global market for specialty endoscopic surgery products totaled approximately $5.8 billion in 2016, with the United States comprising 48.2 percent of sales (or $2.8 billion).⁴ The global market for specialty endoscopic surgery products is forecast to grow at a 4.6 percent compound annual growth rate (CAGR), reaching $7.8 billion in 20214. The global endoscopy equipment market was valued at $24.32 billion in 2016 and is projected to reach $34.82 billion by 2022, at a CAGR of 6.4 percent during the forecast period.⁵

The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as tubular structures) during surgical procedures. The Amsel Occluder Device employs a proprietary mechanical design that enables a vessel clamp to be introduced during open or endoscopic surgery. The Amsel Occluder Device transfixes the target vessel with the clamp to provide closure.
 
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, Mass., and Tel Aviv, Israel. The Amsel Occluder Device addresses an estimated 31 million^6,7 annual U.S. surgical procedures where vessel closure is required.

References
1. Amsel Medical Corporation previously received FDA clearances of Pre-Marketing Notification (510(k)) on January 23, 2015 and September 14, 2017.
2. Patents issued and pending
3. Global Minimally Invasive Surgical Systems Market: Detailed Analysis and Focus on Robotic, Endoscopic, and Laparoscopic Surgeries for 21 Countries – Analysis and Forecast (2018-2025), July 2018
4. Global Specialty Endoscopic Surgery Devices Market Report 2017: Market totaled $5.8Bn in 2016 and is Projected to Reach $7.8Bn by 2021 – ResearchAndMarkets.com, January 2018
5. Endoscopy Equipment Market by Product (Endoscope (Flexible, Rigid, Capsule) Visualization Systems, Endoscopic Ultrasound, Insufflator)), Application (GI Endoscopy, Laparoscopy, Cystoscopy, Bronchoscopy, Colonoscopy, Arthroscopy) – Global Forecast to 2022, December 2017
6. CDC/NCHS National Hospital Discharge Survey, 2010
7. Company Estimates