CorCap gets thumbs-down
This article was originally published in The Gray Sheet
Executive Summary
FDA's Medical Device Dispute Resolution Panel Dec. 15 voted 3-1 against approval of Acorn Cardiovascular's CorCap Cardiac Support Device, citing a lack of data to prove the device's benefits outweigh risks. The polyester mesh wrap, which envelops the heart to treat adults with dilated cardiomyopathy, received a negative review by an FDA advisory panel in 2005 (1"The Gray Sheet" June 27, 2005, p. 3). A 300-patient pivotal trial showed 38% of patients improved with CorCap versus 27% of controls, meeting its primary endpoint. However, FDA officials argued against approval, saying that a substantial amount of data collected early in the trial did not meet the agency's specifications. Acorn has spent $80 mil. developing the device, Richard Lunsford, Acorn CFO, told "The Gray Sheet." The privately held firm will now go back to its sponsors, including Johnson & Johnson, for funds to perform a confirmatory trial, he said...