FDA Seeks More Data Before Kips Bay Clinical Study

Regulators want more information from Kips Bay Medical before allowing the company to conduct a U.S. clinical trial for its medical device; the device is currently being sold in six countries and has been implanted in roughly 250 patients.

Kips Bay Medical, Inc., said Tuesday that regulators want additional information about the Plymouth-based company's medical device before they'll allow it to pursue a clinical study in the United States.

The device is a mesh sleeve that is placed over a saphenous vein graft during coronary artery bypass surgery. It is designed to improve the structural characteristics and long-term performance of the vein graft. And although the U.S. Food and Drug Administration (FDA) “thinks our study is a good study,” they want more information before granting the eSVS Mesh an investigational device exemption, Kips Bay founder Manny Villafa–a told Twin Cities Business on Wednesday.

An investigational device exemption allows the product to be used in a clinical study in order to collect safety and effectiveness data to support approval for market. Kips Bay didn't specify what type of information the FDA is looking for, but Villafa–a said the FDA has “a good communication with us, and we're getting closer to understanding what they want and need from us.”

“All we want to do is get started,” he said. “We're trying to narrow down how the study will look and become something they're comfortable with.”

Kips Bay was founded in 2007 by Villafa–a, a serial entrepreneur behind medical companies like Cardiac Pacemakers and St. Jude Medical. (He was named one of Twin Cities Business' “200 Minnesotans You Should Know” last year and inducted into the Minnesota Business Hall of Fame in 2003.)

Kips Bay's product has already gone through clinical studies in Europe and the United Arab Emirates, and the eSVS Mesh is currently being sold in six countries and has been implanted in roughly 250 patients.

The company plans to launch several post-market clinical studies in Europe during the next three months and believes that the results from those studies will provide the additional data being requested by the FDA.

Villafa–a said the market potential for the eSVS Mesh is greater than for pacemakers, heart valves, and stents combined due to the large volume of bypass surgeries performed each year. He is disappointed with the recent news from the FDA but said it isn't unusual for the launch of medical devices to experience delays.

Kips Bay completed an initial public offering in February. Shares of its stock closed down about 34 percent to $1.87 on Wednesday.


On Wednesday evening, the company made a second announcement, stating that it has received a patent from the U.S. Patent and Trademark Office—the first in the U.S. covering its eSVS Mesh technology. The company also received notice that a second patent application titled “Compliant Venous Stent” has been approved. Shares were trading upabout 2.7 percent to $1.92 during Thursday morning trading.

“This is great news for the Company,” Villafa–a said in a statement. “We believe that the issuance of this patent and the approval of this patent application provide the foundation for very strong and broad-based protection for our eSVS MESH. These are important milestones in the development and growth of our intellectual property portfolio and securing our leadership position in cardiovascular bypass surgery.”