The Ultratine device consists of a triangular platform with 5 tines and a bone peg for attachment to the outer table of the skull.
A 62-year-old female patient. A, Preoperative view. B, Postoperative view, 12 months after surgery, demonstrating satisfactory cosmetic effect and equal elevation and fixation of the forehead. The patient reported greater comfort on the Ultratine (left) side.
A 57-year-old female patient. A, Preoperative view. B, Postoperative view, 90 days after surgery, demonstrating satisfactory cosmetic effect and equal elevation and fixation of the forehead. The patient reported greater comfort on the Ultratine (left) side.
David B. Apfelberg, James Newman, Miles Graivier, Mark A. Petroff, Richard Levine. Multispecialty Contralateral Study of Clinical Experience With the Ultratine Forehead Fixation Device: Evolution of the Original Endotine Device. Arch Facial Plast Surg. 2008;10(4):280–282. doi:10.1001/archfaci.10.4.280
Since the introduction of the Endotine forehead fixation device (Coapt Systems, Palo Alto, California) in March 2003, there has been widespread acceptance of the product. The device has been implanted in over 40 000 patients, and its safety and efficacy have been documented by numerous multispecialty clinical studies.1- 7 Although the device has provided satisfactory elevation and fixation for endoscopic and open and coronal forehead-lifts, a small percentage of surgeons and patients have complained of problems related to persistent palpability and sensitivity owing to the 12- to 15-month absorption time of the biodegradable polymer.
The Ultratine forehead fixation device (Coapt) was cleared by the US Food and Drug Administration in 2006. It has the same dimensions as the original device, but the composition of the polymer has been altered to different percentages of polylactic acid and polyglycolic acid (PLA-PGA) designed for absorption and biodegradation starting at the 2- to 3-month interval.
In July 2006, a multispecialty contralateral study was undertaken comparing the original Endotine to the new Ultratine in a partially blinded contralateral study. The goal was to determine end user (surgeon and patient) satisfaction with the performance of the device. Twelve patients completed the study at 90 days, and physicians rated the overall performance as good or satisfactory at a 100% level.
The Ultratine forehead fixation device consists of a polymer blend altered to result in a softer material that loses biological strength after 2 to 3 months, 50% of its mass after 4 months, and 70% of its mass after 10 months. The dimensions of this device are identical to the original Endotine. It consists of a 0.5-mm-thick triangular platform containing 5 tines (tine length, 3.0-3.5 mm) and a bone peg (length, 3.75 mm) (Figure 1).
The device attaches to the skull by a peg on the bottom of the triangular platform that is press fitted into a 3.75-mm hole drilled into the outer cortex of the frontal bone. With experience, the device may be deployed in about 2 to 3 minutes per side. Both devices are based on the concept of multipoint fixation, in which the 5 tines act to distribute the forces of fixation and elevation over a diffuse area. Thus, no single point is carrying the entire force. This even distribution of force contrasts with the other commonly used methods of fixation employing sutures, in which the sharp edge of the suture acts almost like a scalpel, cutting through the periosteum and galea as the tissue swells during the postoperative period. As the sharp suture pulls through the tissue, there is a descent of several millimeters from the original elevation. Thus, the Endotine device has demonstrated the ability to elevate and fix the forehead in the original position achieved by the surgery without change or regression and redescent.
The Endotine and Ultratine devices provide mechanical fixation until biological fixation occurs (estimated, based on animal studies, at 6-8 weeks). Once the periosteum is firmly and permanently adhered to the outer table of the skull, the device is no longer necessary and subsequently biodegrades and absorbs at varying intervals. The Ultratine device softens and loses 90% of its strength in 60 days and 50% of its mass by 4 months. This rapid degradation after periosteal attachment means that the patient has less palpability and sensitivity after 60 days. The original Endotine loses only 37% of its strength in 60 days and has an absorption and biodegradability profile of 12 to 18 months.
The Endotine and Ultratine devices may also be used in open and coronal forehead-lift procedures. By fixing the anterior forehead flap solidly with the device, the amount of scalp necessary for resection is markedly decreased, and there is less tension on the closure, resulting in a smaller scar and less alopecia.
The study protocol required multispecialty surgeons to implant the Ultratine device in one side of the forehead and the Endotine in the contralateral side. Seventeen patients were enrolled; 12 patients completed the study at 90 days, and 5 patients were lost to follow-up. The follow-up visits were performed at 30 days and 90 days after surgery. Preoperative and postoperative photography was designed to provide identical clinical landmarks, and computerized digitized measurements were designed to measure heights of elevation from fixed points.
At each patient's 90-day follow-up visit, tissue elevation was maintained, and 100% of physicians were satisfied or very satisfied with the results from both devices. In addition, the performance of both devices was rated as good or excellent in 100% of the cases. For both devices, visibility was rated as not visible or slightly visible in 100% of cases. Device palpability was rated as not palpable or slightly palpable in 100% of cases for the Ultratine device and not palpable or slightly palpable in 83.3% of cases for the Endotine device. The 90-day sensitivity ratings for the Ultratine were markedly lower than for the Endotine. Physicians rated the overall performance satisfaction for the Ultratine as 100% (excellent/satisfactory/good) at the 90-day interval.
At 90 days, 100% of the patients were satisfied or very satisfied with the Ultratine device, but only 75% were satisfied with the Endotine. There was slight or no visibility in 100% of the patients with the Ultratine device and in only 91.7% of the patients with Endotine. There was slight or no palpability in 100% of the patients with the Ultratine device and in only 58.3% of those with the Endotine. Sensibility was markedly less in those with the Ultratine (Figure 2 and Figure 3).
In patients with the Ultratine device, by the 90-day follow-up visit, tissue elevation was maintained, the patient's sensitivity had decreased, and the device palpability and visibility had decreased. Overall, physicians rated the product performance satisfaction as 100% (excellent/satisfactory/good). The device exceeded all acceptance criteria set in the study protocol with a high level of patient satisfaction.
The Ultratine forehead fixation device contains a revised polymer concentration of PLA-PGA that results in a softer material at the 3-month interval and 70% bioabsorption in 10 months. Results in a series of 12 patients observed for 90 days indicate that all patients achieved secure and permanent fixation and elevation of their forehead-lifts without regression or redescent. Palpability, visibility, and sensitivity of the device were markedly diminished or absent by the 3- to 4-month interval. The Ultratine device represents an improved evolution over the original Endotine device. It is expected that further experience will result in a general acceptance of the Ultratine device in a wide variety of cases as a satisfactory replacement for the Endotine device.
Correspondence: Dr Apfelberg, Department of Plastic Surgery, Stanford University Medical Center, 1426 Pitman Ave, Palo Alto, CA 94301 (firstname.lastname@example.org).
Financial Disclosure: Drs Apfelberg and Graivier are paid consultants to Coapt Systems and receive stock and financial support. Drs Newman and Graivier are members of the Coapt Systems physician advisory board.