FDA Panel To Weigh Whether 3M Sealant Effectively Closes Pulmonary Leaks
This article was originally published in The Gray Sheet
Executive Summary
3M's lung sealant may shorten hospital stays for lung surgery patients, according to a study led by Mark Allen, MD, Mayo Clinic
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3M panel cancelled
Lung sealant's previously planned May 12 review by FDA's General & Plastic Surgery Devices Panel is cancelled "by mutual agreement between FDA and the sponsor," according to the agency. 3M characterizes the move as a business decision; the in situ polymerizable sealant remains likely to require panel review at a later date. Results from a five-center, prospective, randomized trial suggesting reduced hospital stays with the sealant are scheduled for May publication in the Annals of Thoracic Surgery (1"The Gray Sheet" April 26, 2004, p. 14)...
3M panel cancelled
Lung sealant's previously planned May 12 review by FDA's General & Plastic Surgery Devices Panel is cancelled "by mutual agreement between FDA and the sponsor," according to the agency. 3M characterizes the move as a business decision; the in situ polymerizable sealant remains likely to require panel review at a later date. Results from a five-center, prospective, randomized trial suggesting reduced hospital stays with the sealant are scheduled for May publication in the Annals of Thoracic Surgery (1"The Gray Sheet" April 26, 2004, p. 14)...
3M preparing for lung sealant panel review
FDA's General & Plastic Surgery Devices Panel will convene May 12 to review 3M's in situ polymerizable material for sealing air leaks following pulmonary surgery. In May 2000, FDA approved an expedited PMA for Genzyme's FocalSeal-L surgical sealant for a similar indication, following a unanimous approval recommendation by the panel (1"The Gray Sheet" June 5, 2000, p. 15). [To learn about how to 2watch a webcast of the meeting, go to FDAAdvisoryCommittee.com]...