Company Run by St. Jude Medical Founder Shuts Down

Former Kips Bay Medical CEO Manny Villafaña is on to his next venture. 

Chris Newmarker

Kips Bay Medical shareholders this week voted to dissolve the company after a disappointing clinical trial of its mesh "sleeve" meant to aid in in coronary artery bypass graft surgery.

Manny Villafaña, who was Kips Bay's chairman and CEO until Tuesday, is a serial entrepreneur who playd an integral role in founding Minnesota's medical device hub. Speaking at MassDevice's Device Talks conference in the Twin Cities on Wednesday night, he recalled how the New York Yankees' great Mickey Mantle struck out a lot, but he always came back the next day and kept on swinging. 

"I'm not afraid to swing the bat," Villafaña said. 

The board of Plymouth, MN-based Kips Bay made the initial decision in June. With Tuesday's shareholder vote done, the company plans to file a certificate of dissolution with the Delaware Secretary of State on Thursday.

Villafaña recalled that fundraising was tough for Kips Bay, which started in 2007 as the Great Recession was ramping up. Meanwhile, FDA was raising the bar on what it expected Kips Bay to demonstrate. Villafaña and others at Kips Bay planned to demonstrate a percentage of success comparable to standard care.

"The FDA wanted a higher number of success for us, and that was a really tough bar to meet," Villafaña  said. 

Villafaña is a serial entrepreneur with decades of experience in the medical device industry. He started St. Jude Medical (Little Canada, MN) in 1976. St. Jude is now one of the largest medical device companies in the world.

Villafaña also launched Cardiac Pacemakers Inc., which is now part of Boston Scientific's Guidant business. 

With Kips Bay, the company had already reduced its headcount from 13 to eight employees in January, according to its most recent annual report. The decision to liquidate came after poor early angiographic results from a study in which Kips Bay's eSVS Mesh was implanted using the new surgical implant technique for the device. The nitinol mesh was supposed to wrap around saphenous vein grafts in order to support them.

The clinical feasibility study is now canceled.

Villafaña is still an enthusiastic medical device entrepreneur, though. He had to move up his talk at Device Talks so that he could make it to an 8:30 p.m. meeting related to a new undisclosed company he is starting. 

Villafaña recounted how he once witnessed a heart transplant in Spain. The old heart kept beating on the table and did not stop beating until the new heart started beating inside the patient. 

"When golf is as exciting as that, maybe I'll take on golf," Villafaña said.

Kips Bay Medical's heart was about to stop beating as Villafaña spoke, but it seems that a new venture is gaining a pulse. 

"I'm not ready to retire. I love what I do. I think I still have the energy. I think the brain is still working," Villafaña said. 

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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