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...
You may also be interested in...
Acorn Asks For More Help From Investors After FDA Panel Denies CorCap PMA
Acorn Cardiovascular says it will ask its current investors to fund a confirmatory trial of its CorCap Cardiac Support Device after an FDA advisory panel decided more research is needed before it could support premarket approval
CorCap Efficacy Data Deemed Scant By Panel; Acorn Vows Not To Lose Heart
Acorn Cardiovascular will work with FDA to address panel concerns with CorCap that arose during a June 22 meeting to review the ventricular support device
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.