News | Cardiovascular Surgery | September 19, 2017

Gecko Biomedical Receives CE Mark Approval for Setalum Sealant

Biocompatible, bioresorbable sealant acts as add-on to sutures during vascular surgery

Gecko Biomedical Receives CE Mark Approval for Setalum Sealant

September 19, 2017 — Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its technology in Europe.

The Setalum Sealant is a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.

The technology at the foundation of the Setalum Sealant was developed at the Massachusetts Institute of Technology, Harvard Medical School, and Brigham and Women’s Hospital. The device is based on the adhesive mechanisms found in nature that work in wet and dynamic environments.

“The Setalum sealant can be precisely and easily applied thanks to its viscosity and hydrophobicity and then activated at will to provide an instant hermetic barrier and effective hemostasis. The key features of this polymer technology were selected with physicians and patients in mind, and significantly improves upon the latest generation of hemostatic agents to become a gold standard in vascular surgery,” said Jean-Marc Alsac, M.D., Ph.D., vascular surgeon at the Hôpital Européen Georges Pompidou in Paris, France, and the principal investigator of Gecko Biomedical’s BlueSeal clinical study.

The BlueSeal clinical study was a prospective, single-arm and multicenter clinical investigation performed at four French university hospitals and undertaken in patients necessitating a carotid endarterectomy. Performance of the sealant was evaluated by the percentage of immediate hemostasis following clamp removal. Based on a sequential Bayesian design, the recruitment was stopped at 22 enrolled patients given the fulfilled performance criteria and the optimal safety profile of the sealant. Immediate hemostasis was achieved in 85 percent of patients and all recorded adverse events were found to be representative of those commonly occurring in patients necessitating vascular reconstruction with none considered as related to the sealant.

For more information: www.geckobiomedical.com

Related Content

Heart and Lung Surgery Patients May Be at High Risk for Opioid Dependence

Image courtesy of the American Heart Association

News | Cardiovascular Surgery | August 22, 2019
The amount of opioids prescribed for patients after heart and lung surgery has a direct relationship with the risk for...
Keck School of Medicine Promotes Patient Diversity in Cardiac Surgery Clinical Trials
News | Cardiovascular Surgery | July 26, 2019
A highly competitive $4.5 million grant from the National Institutes of Health (NIH) National Heart, Lung and Blood...
Google Doodle Celebrates Coronary Artery Bypass Graft Pioneer René Favaloro
News | Cardiovascular Surgery | July 12, 2019 | Jeff Zagoudis, Associate Editor
Internet search engine giant Google unveiled a new Doodle on its homepage Friday, July 12, celebrating the life and...
Open Heart Surgery Outperforms Stents in Patients With Multivessel Disease
News | Cardiovascular Surgery | May 03, 2019
Coronary artery bypass grafting (CABG) surgery may be the best treatment option for most patients with more than one...
SherpaPak Cardiac Transport System Cleared for Pediatric and Small Donor Hearts
Technology | Cardiovascular Surgery | February 01, 2019
Paragonix Technologies Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) for a design...
Transplanting Pig Hearts Into Humans One Step Closer. A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

News | Cardiovascular Surgery | December 11, 2018
The scientific journal Nature recently published an article from Munich University Hospital which describes the long-...
Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Overlay Init