When an FDA panel voted in June 2005 against recommending approval of Acorn Cardiovascular's (New Brighton, Minnesota) CorCap cardiac support device, company officials told reporters Acorn remained "confident and committed" to working with FDA to win eventual approval (Medical Device Daily, June 24, 2005).
Then another setback came in December when an FDA dispute resolution panel rejected the company's appeal for CorCap (MDD, Dec. 20, 2006), saying that more study was needed to prove the device is safe and effective when used on patients. Acorn was only the second company in FDA history to go before the dispute resolution panel followed by a third company, Cardima (Fremont, California), which went before the dispute panel last month (MDD, April 23, 2006).
But at last, Acorn may finally be on its way to winning FDA approval for CorCap now that the company and the agency have reached an agreement for a new clinical trial for the heart-failure device.
"When we went through that dispute resolution panel coming out of that in December with a no vote, it was difficult, but I think the agency clearly wanted to work with us," Richard Lunsford, Acorn's president/CEO, told Medical Device Daily.
Lunsford said the company has been working together "intensely" over the past five months with Dan Schultz, MD, director of the Center for Devices and Radiological Health (CDRH), and Bram Zuckerman, MD, director of the Division of Cardiovascular Devices, to design a confirmatory trial that would alleviate the concerns of the panels.
"We feel good about this, I think the agency has reached out tremendously," Lunsford said.
In fact, within days of the dispute resolution panel meeting in December, Lunsford said Acorn officials were in Washington meeting with FDA officials to discuss the trial.
"We went out there right away to work on follow-up issues . . . it has been an intensely collaborative effort that has taken a long time but it's worth it . . . " Lunsford said.
CorCap is a sock-like device designed to support the heart, which often swells to three times its normal size as heart failure progresses.
Acorn's original study enrolled 300 heart-failure patients at 29 sites in the U.S. and Canada, calling it the largest cardiac surgery multicenter trial that's ever been conducted. The four-arm trial included a total of 107 patients that received either CorCap along with medical therapy or medical therapy alone. Another 193 enrollees who underwent mitral valve surgery also were randomized between CorCap vs. follow-on medical therapy.
The device group showed improvements in several categories. This group had more patients improved according to New York Heart Association (NYHA) functional class (38% vs. 27%) and fewer patients "worsened" (37% vs. 45%). The device group had fewer follow-on major cardiac procedures (such as heart transplant, implantation of a ventricular assist device or need for electrical stimulation therapy), compared to the control group. And using a quality-of-life assessment, the device group reported greater improvement in quality of life over the control group (MDD, Nov. 9, 2004).
The confirmatory trial will enroll 50 patients beginning this summer, with the aim of completing enrollment by early next year. The device would be used on all of the study's patients to see if the outcome essentially confirms earlier results.
If the smaller study is successful, Schultz will decide whether to approve the device or convene another panel. The company said it anticipates approval of the device by the end of 2008 or the beginning of 2009.
Lunsford said the trial and overall company operations would cost about $15 million, probably funded with a cash infusion from a large cardiovascular company that has heart-failure interests, venture capitalists, or the company's current investor group.
In a press release, Lunsford said many of the original investors have agreed to support Acorn through the next phase of the FDA approval process and the assumed commercial launch of the device. In addition it said, several cardiovascular companies and venture capital firms have expressed interest in providing needed funding.
Lunsford said it would have been cost-prohibitive for the small company to do another large trial.
The CorCap received CE mark approval in Europe in 2000, and the company said more than 465 patients worldwide have received the treatment.
According to Acorn, up to 50% of patients with advanced heart failure die within five years of diagnosis. Heart failure affects more than five million people in the U.S. and 25 million people worldwide. The company noted that an estimated 550,000 new cases are diagnosed each year in the U.S. alone.