Genesee BioMedical Receives FDA 510(k) Clearance for ATLAAS™ Epicardial Left Atrial Appendage Occlusion Device
Second FDA clearance in less than two years reflects Genesee BioMedical’s design, manufacturing, regulatory expertise, & commitment to advancing cardiac surgery
This is our second major approval in less than two years. That pace reflects our commitment to bringing new technology to cardiac surgery, and it is a commitment we intend to keep.”
DENVER, CO, UNITED STATES, May 29, 2026 /EINPresswire.com/ -- Genesee BioMedical, Inc., a medical device company with decades of experience designing, manufacturing, and commercializing technologies for cardiac surgery, announced today the U.S. Food and Drug Administration (FDA) 510(k) clearance for ATLAAS™ (Atraumatic Left Atrial Appendage System) developed for use in cardiac surgical procedures.— Matt Dambeck, CEO of Genesee BioMedical
“Today marks a pivotal moment for our company, and I am incredibly proud of the work our team has done to get us here,” said Matt Dambeck, CEO of Genesee BioMedical. “This is our second major approval in the cardiac surgery space in less than two years. That pace reflects a deliberate focus and a genuine commitment to bringing new technology to cardiac surgery, and it is a commitment we intend to keep.”
ATLAAS™ was developed in collaboration with Niv Ad, MD, a renowned cardiac surgeon and internationally recognized authority in atrial fibrillation and structural heart procedures. The device was specifically engineered to facilitate epicardial exclusion of the left atrial appendage during cardiac surgical procedures, with the goal of reducing stroke risk in patients with atrial fibrillation. Designed to address key surgical challenges, ATLAAS™ incorporates a differentiated non-spring-based inflatable occlusion system centered around an innovative latch-based closure mechanism. This advanced design enables controlled deployment, intraoperative repositionability, and enhanced procedural flexibility throughout implantation, supporting both physician usability and procedural precision.
“As an inventor, it is important to work with a company that understands how to bring technologies for cardiac surgery from concept to reality,” said Niv Ad, MD, cardiac surgeon and inventor of ATLAAS™. “Genesee has spent decades working alongside cardiac surgeons and building a track record of product development, regulatory execution, and innovation in this space. That experience played an important role in bringing ATLAAS™ forward.”
This clearance further demonstrates Genesee BioMedical's ability to bring new cardiac surgery technologies to market while maintaining an active commercial portfolio spanning annuloplasty rings & bands, surgical retractors, aortic valve repair tools, robotic-assist instruments, and graft markers. The company controls every stage of the R&D process, from initial concept through design, manufacturing, regulatory clearance, and commercial launch.
“It has been exciting to work alongside Dr. Ad on this device. His surgical insight and rigor push you to consistently challenge the team to think deeper and execute with greater precision. That kind of partnership is exactly what Genesee was built around.” - Matt Dambeck, CEO, Genesee BioMedical, Inc.
The left atrial appendage occlusion market continues to evolve as cardiac surgery teams explore new approaches to appendage management. With ATLAAS™, Genesee BioMedical enters that segment with a cardiac surgeon-led, epicardial device that reflects the same design discipline and development rigor behind its established portfolio, and with a pipeline that the company intends to keep expanding.
About Genesee BioMedical, Inc.:
Genesee BioMedical, Inc. is a medical device company focused on developing innovative solutions for cardiac surgery. The company's products are built to perform across every surgical setting: open, minimally invasive, and robotic-assisted. Learn more: https://geneseebiomedical.com/
Angie McGraw
Genesee Biomedical, Inc.
amcgraw@geneseebiomedical.com
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