GI Windows Medical has secured a breakthrough device designation from the Food and Drug Administration (FDA) for its self-forming magnetic compression anastomosis device.
The device is indicated for small bowel end-to-end anastomosis for ileostomy reversal or tissue resection.
The breakthrough devices programme is designed by the FDA to select medical devices that show potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
As part of the programme, the agency will enable priority review and interactive communication of GI Windows’ device development and clinical trial protocols during the premarket review process.
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The magnetic anastomosis technology developed by the company offers a number of considerable benefits for patients with colorectal disease.
In the US, colorectal complication rates are high due to anastomotic leaks, surgical site infections and bleeding, leading to high readmission rates and increasing the total cost to the healthcare system.
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GI Windows’ anastomosis device is designed to help surgeons deliver less invasive solutions by using magnetic compression anastomosis. This enables clinicians to enhance patient outcomes and reduce healthcare costs.
GI Windows President and CEO Brian Tinkham said: “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. We look forward to working collaboratively with the FDA to help prioritise development and access for patients.”
GI Windows is now sponsoring several studies to assess the safety, efficacy and durability of the magnetic anastomosis creation throughout the GI tract.
The company is a spin-off of Beacon Endoscopic, which was acquired by Covidien in 2014.
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