Pluromed Files PMA for FDA Approval of LeGoo Internal Vessel Occluder

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Pluromed, Inc. announced today that it has filed the final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for LeGoo Internal Vessel Occluder. It is estimated that each year over 20 million U.S. patients undergo procedures that necessitate temporary occlusion of blood vessels.

We have designed LeGoo to simplify temporary occlusion of blood vessels during surgical procedures

Pluromed, Inc. announced today that it has filed the final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for LeGoo Internal Vessel Occluder. LeGoo is intended to be used to temporarily occlude blood vessels up to 4mm in diameter, in patients undergoing non-neurovascular procedures that require temporary occlusion of a blood vessel. It is comprised of a non-toxic, biocompatible gel that is water-soluble, and has reverse thermosensitive properties. At room temperature it is a viscous but injectable liquid, and it transitions to a temporary self-forming polymeric plug at body temperature.

“We have designed LeGoo to simplify temporary occlusion of blood vessels during surgical procedures,” said James A. Wilkie, Pluromed Vice-President of Operations, who led the PMA process for Pluromed over the last few years. “It eliminates the need to clamp the vessel from the outside. It also keeps the vessel substantially round, allowing the surgeon to suture a graft into a round vessel, which is easier than sewing a vessel that has been distorted or flattened by a clamp or a vessel loop. Most importantly and unlike any traditional tool, LeGoo does not damage blood vessels because compressive forces are not applied: it is atraumatic, which is especially important for all patients with fragile and diseased vessels who undergo vascular or cardiovascular procedures.”

It is estimated that each year over 20 million U.S. patients undergo procedures that necessitate temporary occlusion of blood vessels.

"Completing and submitting the PMA is a significant milestone for the company,” said Jean-Marie Vogel, President and CEO of Pluromed. "We believe that LeGoo, if approved by the FDA, offers the potential to improve healthcare for millions of patients suffering from vascular and cardiovascular disease by providing a better surgical field for the surgeon and reducing the risk of injury to blood vessels, and to lower healthcare costs by reducing the need for supplementary procedures. Beyond LeGoo, we intend to bring additional non traumatic products to market based on our platform technology.”

The PMA includes data from the “LeGoo Internal Vessel Occluder vs. Traditional Vessel Loops” clinical trial, a multicenter randomized study intended to evaluate the safety and efficacy of LeGoo™ as an atraumatic temporary vessel occluder. Results from the study revealed that 88% of the patients treated with LeGoo satisfied the protocol primary trial endpoint, defined as satisfactory hemostasis, as compared to only 61% of the patients treated with traditional vessel loops. The study was based on 110 patients undergoing off-pump coronary artery bypass surgery and was conducted in Germany, France, The Netherlands and Canada from August 2008 to March 2010.

A PMA is a regulatory pathway to market medical devices that have no incumbent products with which the FDA can compare the safety. The study has not yet been reviewed by the FDA and at this time LeGoo is not available for commercial sale in the U.S.

About Pluromed

Pluromed, founded in 2003, is a commercial Woburn, Massachusetts based medical device company that addresses the need to control bleeding during surgical and interventional procedures, a $2B market that includes cardiac and vascular surgery, kidney and liver surgery, reconstruction surgery and trauma/battlefield injuries. LeGoo™ Internal Vessel Occluder, based on the Company’s patented proprietary technology, is a liquid polymer, which hardens into a plug at body temperature. It dissolves at the end of the procedure, and is eliminated in urine. The company has started distribution in Europe, where LeGoo is approved and has been used in over 1,000 clinical cases. In 2010 the Company completed enrollment in a multicenter clinical study towards FDA approval.

The Company has entered a worldwide distribution agreement with Boston Scientific for the Company’s BackStop product line for removal of kidney stones. BackStop received US FDA clearance in May 2009 and is also approved in Europe and Canada.

The Company is at advanced stages of development of its third product line. Lumagel™, developed under NIH grants in collaboration with the Lahey clinic and UCLA Medical Center, is the company’s first oncology product and is designed to greatly improve and facilitate kidney and liver surgery.

Pluromed invests heavily in a combination of patents, trademarks, trade secrets and non-disclosure agreements to protect its intellectual property. At present, the Company is reliant on technology in five issued patents, including one patent exclusively licensed to the Company by UCLA and one recently allowed very broad method patent that covers its core vascular business, and twelve other pending patent applications, including two patent applications co-owned with Massachusetts General Hospital for which the Company has an exclusive License, one patent application co-owned by The Lahey Clinic for which the Company has an exclusive license, and one patent application co-owned by Dartmouth-Hitchcock Medical Center for which the Company has an exclusive license.

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JEAN-MARIE VOGEL
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