Artivion, an Atlanta-based medtech that focuses on cardiac and vascular surgery, received pre-market approval (PMA) for its aortic stent graft system.
The FDA approval also triggered an option by Artivion to acquire its partner and developer of the system—Endospan—for $150 million, which it can exercise within 90 days of the PMA being approved, the company said in an April 7 press release.
The minimally invasive aortic arch disease, including chronic aortic dissections in patients who in the past faced the prospect of open-chest surgery.
Data from the Nexus Triomphe IDE trial showed a 90% patient survival rate from lesion-related death, 90% didn’t experience a disabling stroke at 1-year post-treatment, and 98% weren’t in need of reintervention due to endoleaks at the one-year mark.
“The Triomphe data has consistently demonstrated the clinical value of this technology, and we are proud to have supported Endospan on this journey,” Pat Mackin, Artivion’s chair, president and CEO, said in the release. “We have proactively put the financing in place to support a potential acquisition, and we are moving diligently to finalize our considerations around the option.”
The company is expected to update shareholders “soon” on the option to buy Endospan, he added in a statement.
The Nexus approval comes a little over a year after the company got the go ahead from the FDA for its AMDS Hybrid Prosthesis, which helps treat what are referred to as acute DeBakey type I aortic dissections—named after the late Dr. Michael E. DeBakey, who pioneered surgical treatment of aortic diseases.
Such dissections occur when the innermost layer begins to pull away from the aortic wall, starting in the ascending side of the arch and then continuing around down through the descending side—and specifically those that hamper the flow of oxygenated blood to the rest of the body’s organs.