Kips Bay Medical ($KIPS) says it has successfully crossed the 500-patient threshold for commercial implants in Europe and the Middle East of its artery bypass graft mesh device. In the U.S., the Minnesota device company says it is now gathering data and planting seeds for a hoped-for pivotal trial to enable approval here.
Manny Villafaña, chairman and CEO of Kips Bay, noted the milestones in a letter to shareholders. He added that there have been "no reportable adverse events" related to its eSVS mesh since overseas commercialization efforts began in June 2010.
In the U.S, the company continues a feasibility trial at four centers, including the Mayo Clinic in Rochester, MN, and the Texas Heart Institute in Houston, TX. All, as Villafaña writes, have either enrolled, or are in the process of enrolling patients. More stand ready, he said, pending FDA approval to expand the site roster. The FDA currently lets the company enroll up to 15 patients at four U.S. sites, but Kips Bay wants to expand that to 50 patients at up to 10 sites and hopes for approval by the end of 2013, Kips Bay COO/CFO Scott Tellen told FierceMedicalDevices in an email.
In the meantime, Kips Bay has continued to collect data from approved sites in Europe. Based on the combined results over the next year, the trials/implants data will form the basis of another push with the FDA, this time to obtain approval for a U.S. pivotal trial, Villafaña said.
In Europe, the strategy now is all about driving adoption. Villafaña said the company brought on two experienced folks to help educate and train surgeons and "the entire cardiac support team" about the product. It's unusual and simple--the eSVS Mesh is placed over a saphenous vein graft during coronary artery bypass grafting surgery to help improve the quality and performance of the graft.
Importantly, Kips Bay has also made progress on the national insurance front, at least overeas. Villafaña wrote that Switzerland and Germany's national healthcare systems have both issued reporting codes for the product, which kick in Jan. 1, 2014 and will allow insurers to track the use of the eSVS Mesh.
"These codes provide a first step toward eventually establishing reimbursement for our device," Villafaña wrote.
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