DOI: 10.1097/01.PRS.0000173535.94673.58
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PMID: 15988293
Issn Print: 0032-1052
Publication Date: 2005/07/01
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Excerpt
We are writing in response to the Safety and Efficacy Report authored by Greg Evans and the Plastic Surgery Educational Foundation DATA Committee, entitled “Heads Up on Brow Lift with Coapt Systems Endotine Forehead Technology” (Plast. Reconstr. Surg 113: 1504, 2004). Dr. Evans and the committee presented a summary of the Endotine product and requested additional information on the second-generation device (composed of a different polymer) as well as longer-term studies in larger patient populations. We are happy to provide this information.
The new polymer is a mixture of lactic acid and glycolic acid, a combination material with extensive use in the face and cranium. Since its introduction in 2002, the Endotine forehead device has been used by more than 1200 U.S. surgeons and hundreds more abroad in the specialties of plastic surgery, facial plastic surgery, and oculoplastic surgery. Approximately 150 patients received the original device from January to December of 2002. The current device (with a thinner platform and an option for shorter tines) was introduced in January of 2003. Since then, more than 17,000 devices have been shipped and more than 6500 patients have had the device implanted. From the beginning, all user complaints have been tracked by the company. The most common complaint is faint palpability lasting approximately 12 weeks. There have been no reports of infection.
A recent study by Berkowitz of 21 patients conducted between April of 2002 and September of 2003 compared the original device, which consisted of a 1-mm-thick platform with 3.5-mm tine projection, with the second-generation product, which has a 0.5-mm platform and 3.0-mm tine projection. There were no reports of pain, device extrusion, or removal. Average elevations of the brow (midpupil to superior brow) ranged from 4.3 to 4.8 mm. There was no incidence of alopecia from this internal device (unpublished data).
Sterling Baker, an oculoplastic surgeon, surveyed 50 consecutive patients at a minimum period of 3 months after surgery. Forty-five percent of the patients were male. Most patients rated their happiness with the result as “very high.” Forty-four patients could palpate the device after implantation, but the majority said that their discomfort became barely noticeable after 6 months. Two first-generation devices were explanted, but no patients with second-generation devices elected removal (Cosmetic Surgery Times, April 1, 2004).
Evans and the committee incorrectly report that the U.S. Food and Drug Administration instigated a drill bit recall. Coapt Systems voluntarily began the recall after receiving a field report of a failed stop-collar. The current drill bit is a single piece.
In addition to the Endotine device for endoscopic and open forehead lift, the company has developed other unique fixation devices for facial cosmetic surgery. Products in production or development include anchors for midface fixation from the temporal or infraorbital approach; a neck tissue elevator for “witch’s chin” deformity; a platysmal sling for improving the cervicomental angle; a lateral tarsorrhaphy/canthal fixation device; and a transblepharoplasty brow suspension device. The company is also actively studying polymers and polymer treatments in a continual effort to optimize the device functionality/absorption ratio.
The undersigned serve as board members, founders, and advisors for Coapt and have a direct financial interest in the company.
