Medical Device Daily Washington Editor
WASHINGTON – Last week, a negative FDA panel vote left officials at Acorn Cardiovascular (St. Paul, Minnesota) “surprised,” according to Rich Lunsford, company president and CEO.
The Circulatory System Devices Panel of the Center for Devices and Radiological Health voted 9-4 against recommending approval of Acorn’s CorCap cardiac support device (Medical Device Daily, June 24, 2005), a high-tech polyester mesh device that is positioned surgically around the heart like a sock.
“We were told by a number of different entities that are expert panel watchers that this was one of the best, most comprehensive presentations they have ever seen – the preclinical data, the clinical trial data, safety data, the way it was presented by the doctors,” Lunsford told MDD. “We felt we were well-prepared.”
Despite the “brief setback,” Lunsford said that he, company management and investors remain “as optimistic as we were prior to panel.”
Privately held Acorn has positioned the device as an alternative therapy for heart failure patients with enlarged hearts and decreased pumping function who no longer respond to other therapies. CorCap is the company’s only product.
It is the first medical device specifically designed to address the problem of enlargement of the heart by providing direct support to it, improving its structure and returning it to a more normal shape, thus designed to help it pump more efficiently, the company says.
According to a short summary released by the FDA following the meeting, the panel’s concerns were “a lack of clinical outcome data, missing effectiveness data and potential risk to patients.”
“We were surprised, and I think the FDA was a little surprised, too,” Lunsford said. He explained that the company had worked closely with the agency prior to submitting its data. Acorn already has had meetings with the FDA on the next step for the device submission.
“We already are in dialogue with the FDA,” he said, noting there have been two meetings so far. “The outlook is reasonable for us to go through the continued process with them [the FDA] and ultimately gain approval.”
Lunsford said the company is preparing to go through the panel transcript with agency representatives and address key issues that came from the hearing. He described the agency as being ready and willing to help.
Acorn would not have to return to another panel hearing but would present data to answer the agency’s post-panel questions, he said.
Getting those questions answered would lead to approval, the company hopes. Lunsford told MDD that all the panel’s concerns could be answered by re-examining the company’s current data set. He said Acorn was eager to clear up any confusion there may have been on the panel’s part about the data presented.
“Our initial impression is that with the present data set we’re going to be able to deal with the questions that came up at panel,” he said. “The FDA and Acorn executives have been in discussions to identify the issues that came up in panel and to work together in working tighter to address those issues effectively.”
No specifics about timeframe have been discussed, but Lunsford said the “potential for approval remains reasonable” toward the end of this year or beginning of 2006.
“If you asked me to handicap it, I think we’ve got a very good shot at having this approved by the end of the year,” he said.
One of the issues Acorn will be working on is labeling, Lunsford said, working with the agency so that the device is marketed to the populations the FDA believes are appropriate based on the evidence available.
Some panel members also expressed concern about the impact CorCap would have on the effectiveness of possible procedures after the device is implanted, such as a coronary artery bypass graft, or CABG.
Lunsford said that such a procedure would still be possible, though not that common. “The probability of redoing a CABG operation on a patient that has heart failure that is declining is very, very low,” he said. “And with more and more devices in the cath lab being successful, you don’t have to do bypass as often because of drug-eluting stents. You can perform an intravascular procedure effectively with this device on the exterior of the heart.”
The responses from cardiologists and surgeons that have seen the company’s data presented at recent meetings of the American Heart Association (Dallas) and the American Association for Thoracic Surgery (Beverly, Massachusetts) have been “very positive,” he said.
In the near future, he said Acorn also would initiate a trial specifically to evaluate the use of CorCap concomitantly with CABG.
Overall, Lunsford said he would not categorize the panel’s decision as a major setback, but said it would push back the company’s efforts to raise financing for the product’s launch following its anticipated approval.
“We planned on coming out of panel and ready to raise money immediately for commercialization,” Lunsford said. “With the vote that came about, we aren’t going to be able to prepare for commercialization as aggressively as we would have.”
He said the company is well positioned through the third quarter of next year, describing Acorn as in “good shape financially.”
“Right now the strategy has shifted to getting FDA approval then to close out financing,” Lunsford said. “Our confidence level for approval hasn’t changed, but we’re just going to have to go through another couple of steps. The data is very comprehensive.”
Current investors in Acorn are willing to continue to invest in the product, he said. One of the company’s current investors is Johnson & Johnson (New Brunswick, New Jersey).
The company’s board of directors has “re-emphasized its support,” he said. “They are confident in the study. We have very strong support right now. Investors that are really ready, and the management team and the board are working very closely. If timelines are pushed out to a year, that would be difficult, but we don’t think that is going to happen.”
Other possible strategic investors, such as Medtronic (Minneapolis), Guidant (Indianapolis), Boston Scientific (Natick, Massachusetts) and St. Jude (also St. Paul) all are watching the company and the process very closely, Lunsford said. Representatives from all four were present at the panel meeting.