GI Windows Medical’s self-forming magnetic compression anastomosis device indicated for small bowel end to end anastomosis for ileostomy reversal or tissue resection, has been granted Breakthrough Device Designation by the FDA.
“GI Windows has developed a compelling technology that may provide several significant benefits for our patients with colorectal disease.” said Dr Christopher Thompson, Director of Endoscopy, Professor of Medicine Harvard Medical School at Brigham & Women’s Hospital, “This is an exciting time in healthcare with the FDA working closely with the companies designated as having disruptive technology, to help improve the access for our patients.”
The GI Windows technology is designed to help surgeons deliver less invasive solutions via magnetic compression anastomosis, allowing clinicians to improve patient outcomes and reduce healthcare costs by creating new capabilities in healthcare.
The Breakthrough Devices Program is a voluntary programme for select medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under the programme, the FDA will provide GI Windows with priority review and interactive communication regarding device development and clinical trial protocols, during the premarket review process.
“This designation is a major milestone for GI Windows, as we aspire to change the paradigm in anastomosis creation throughout the GI tract. Our entire team has worked hard in developing the technology and evidence to achieve this designation from the FDA,” said Brian Tinkham, President & CEO of GI Windows. “We look forward to working collaboratively with the FDA to help prioritize development and access for patients.”
GI Windows Corp is a clinical-stage, venture-backed medical device company dedicated to developing the first fundamental breakthrough in anastomoses technology in both delivery and tissue fusion. GI Windows is currently sponsoring numerous trials to evaluate the safety, efficacy, and durability of the magnetic anastomosis creation throughout the GI tract.