SAN FRANCISCO – Boston Scientific Corp. said its bid to bring its Lotus Edge transcatheter aortic valve technology (TAVR) to the U.S. will continue as planned. During a Tuesday breakout session at the 35th annual J.P. Morgan Healthcare conference, the company said the issue had been resolved. Boston Scientific also noted it wasn't a design flaw in the device nor were there any safety issues. The firm said a fix to Lotus Edge required a combination of "minor process and specification changes", rather than any meaningful, costly and lengthy product redesigns. News of the firm's FDA plans shot shares of Boston Scientific (NYSE:BSX) up by nearly seven percent during Tuesday trading.

The Marlborough, Mass.-based company had to temporarily recall Lotus Edge in Europe to investigate a locking mechanism issue back in October of 2016.

"We don't think it impacts our PMA submission timeline," Michael Mahoney, Boston Scientific's president and CEO said on Tuesday. "We expect to have approval by year end in the U.S. and we look forward to getting back on the market in Europe."

Boston Scientific said it would continue Lotus sales in Europe by 3Q17. The company received the CE mark for the device in September 2016. (See Medical Device Daily, Sept. 20, 2016.)

If Boston Scientific could gain FDA approval for Lotus, it would be the third TAVR player on the U.S. market with such a technology. Irvine, Calif.-based Edwards Lifesciences Corp. and Dublin-based Medtronic plc. both have FDA approval for TAVR devices.

Edwards was the first to market with a TAVR device in the U.S. when it gained FDA approval for the Sapien valve about five years ago. (See Medical Device Daily, Nov. 4, 2011.) Medtronic entered the market with its Corevalve technology about two years ago.

Boston Scientific's Lotus device stands out because it's known for low rates of paravalvular leak, which is a common side effect of TAVR. The Lotus Edge is designed to continue these low PVL rates with its adaptive seal technology, Boston Scientific said.

But the company still has one last major hurdle to climb with the device and that's the ongoing TAVR patent fight with Edwards.

Boston Scientific filed suit against Edwards alleging that the next-generation Sapien 3 valve infringes a patent it acquired along with Sadra Medical Inc. for $450 million in 2010. (See Medical Device Daily, Nov. 22, 2010.) Edwards then countersued, claiming the Lotus valve violates its patent for a "Prosthetic heart valve and method."

About three years ago, Medtronic ended its six-year patent war with Edwards over its TAVR valves. (See Medical Device Daily, May 21, 2014.) The Dublin-based company agreed to pay out $750 million with at least $40 million a year in royalties until 2022 to Edwards, to settle the case.

During a panel at the J.P. Morgan Healthcare conference, Boston Scientific executives remained tight-lipped about the case only noting that the company would vigorously defend its intellectual property.

Boston Scientific executives however, were more open regarding the firm's structural heart business, which includes Lotus and the Watchman LAA Closure technology. The firm provided initial 2017 worldwide structural heart revenue guidance of $300 million. Rick Wise an analyst with Stifel, said that Boston Scientific's 2017 structural heart guidance represents "60 percent growth vs. 2016 guidance of $175 million to $200 million."

The Watchman device has been one of the company's most significant approvals. Boston Scientific received the nod from the FDA for the device about two years ago. (See Medical Device Daily, March 17, 2015.) Watchman is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

Mahoney said Watchman was performing very well and had helped boost Boston Scientific's structural heart business.

"Our structural heart business is the fastest growing [segment] in the company," Mahoney said on Tuesday.