Amsel Medical has secured 510(k) pre-marketing notification from the US Food and Drug Administration (FDA) for its Amsel Endo Occluder device.
Image: A physician training to use an endoscope. Photo: Courtesy of edgar carrasco/Wikipedia.org
Amsel Endo Occluder device is a 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 2.0mm to 7.0mm diameter.
The device can be used during endoscopic procedures such as laparoscopic procedures, for permanent secure occlusion of blood vessels and tubular (ductal) structures.
The mechanical occlusion clip is delivered through a needle that transfixes the target vessel while clamping it shut, when deployed.
The latest product from the company is expected to address an estimated 31 million annual US surgical procedures where vessel closure is required.
Amsel Medical founder and president Arnold Miller said: “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 US 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.”
The minimally invasive surgical systems includes techniques such as laparoscopy and endoscopy. Laparoscopy is a minimally invasive surgical procedure, used to examine the internal organs inside the abdomen.
Endoscopy is also a minimally invasive procedure, which allows both operations on more fragile patients, especially the elderly and in treating complex diseases such as cancer.
Some of the benefits of endoscopy include reduced post-operative pain and reduction in risks of complications, rapid healing, lighter anesthesia, with shorter period of hospital stay.
Surgery, interventional radiology and advanced endoscopy have all claimed to have developed minimally invasive techniques for treating a wide range of diseases, adding to the positive impact on patients’ postoperative outcomes.
The estimated global market for specialty endoscopic surgery products totaled about $5.8bn in 2016 and the US comprised of 48.2% of sales ($2.8bn). The global market for these products is estimated to grow at a 4.6% per year reaching $7.8bn in 2021.
Founded in 2011, Amsel Medical is a development stage medical device company, with operations in Cambridge, Massachusetts and Tel Aviv, Israel.