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7/31/2010
Novel polycaprolactone dermal filler gains popularity in Europe
PCL found in Ellans is the same material found in some resorbable sutures, other surgical devices
Novel polycaprolactone dermal filler gains popularity in Europe

PCL found in Ellans is the same material found in some resorbable sutures, other surgical devices
Ellans may be used for volume-depleted areas, enhancement of zygomatic arch, nasolabial folds and marionette lines
A revolutionary new filler product known as Ellans (AQTIS Medical, Netherlands) boasts a tunable longevity, total bioresorbability and a sustained performance, say two European doctors who use the product regularly. The filler, which is composed of polycaprolactone (PCL), is currently available only in Europe, but plans to enter the U.S. market are under way, with the hope of achieving Food and Drug Administration approval toward the end of 2011, according to Henk Super, AQTIS Medical's chief operating officer.

Current fillers are composed of hyaluronic acid (HA), calcium hydroxylapatite or collagen. Ellans is composed of PCL, a well-known, completely bioresorbable soft medical polymer that has been used for decades in CE-marked and FDA-approved commercial bioresorbable product applications.

"The PCL contained in Ellans is the same material that you find in some resorbable sutures and other devices in surgery. The experience with PCL spans over 40 years in medicine, and it has a solid proven safety record in terms of biocompatibility," says Kostas Gritzalas, M.D., a dermatologist in private practice in Chalkis, Greece. "In my opinion, the 100 percent biodegradability, decades-long excellent safety record and never-before-seen long-lasting cosmetic results make this filler extremely interesting for aesthetic interventions."



A 46-year-old female patient before receiving initial suboptimal correction with Ellans-S. One touch-up was done one month after the initial procedure.

FOUR STRENGTHS Ellans comes in four strengths: S, M, L and E. Each strength consists of a combination of bioresorbable polymer spherical microspheres and gels. All four strengths have the same characteristics, including smooth, spherical microspheres, particle-size distribution (25-50 um), particle concentration, gel viscosity and particle gel homogeneity and injectability. According to the company, the difference between the strengths is their initial molecular weight of PCL molecular polymer chains within the microspheres themselves, allowing for a predictable controlled bioresorption and, therefore, a tunable longevity.

"Ellans can offer the cosmetic patient a personalized and tailored treatment with aesthetic results intended to last at least twice as long as any other leading filler. Though these are still early days, I believe that this filler will stand up to the more established fillers and likely surpass them," says Ali Pirayesh, M.D., F.C.C., consultant plastic, reconstructive and aesthetic surgeon at the Dutch Clinic, Amsterdam, and University Hospital, Gent, Belgium.


The same patient 15 months after the one-month touch-up. No additional touch-ups were performed between the one-month touch-up and the 15-month photo. Approximately 1.78 mL of Ellans-S was used for treatment of the nasolabial fold.

Ellans can be used for typical cosmetic thorns such as volume-depleted areas and soft tissue filling needed around the nasolabial folds and marionette lines, as well as enhancement of the zygomatic arch, and, in selected cases, softening of wrinkles around the forehead and glabella. For these indications, Dr. Pirayesh says he often uses the S and M filler strengths. The L and E strengths last longer and may prove ideal for deeper, more profound wrinkles and other more intense volumizing issues, such as those seen in lipoatrophy and cosmetic reconstructive cases.

CLINICAL TRIAL Data from an AQTIS-sponsored clinical trial shows cosmetic results lasting up to 15 months with the S strength, and at least up to 18 months with the M strength. Future data obtained from the ongoing trial is expected to indicate how long results of the L and E strengths will last. Both the L and E strengths are expected to have an even longer duration, out to four years, due to the nature of the predictable biodegradation technology. No adverse events have been reported thus far in the clinical trials, and patients appear to favor the treatment compared to other fillers, according to Mr. Super.

"Ellans also sets itself apart from other fillers in its extreme ease of injection. Though there are four different strengths, the viscosity remains the same with all of them, and injecting them into the skin is almost effortless due to the novel molecular constitution of PCL," Dr. Gritzalas says.

According to Dr. Pirayesh, Ellans has a distinct scientific and clinical appeal. It can effectively address all of the indications that Radiesse (calcium hydroxylapatite, BioForm Medical) and Sculptra (poly-L-lactic acid, Sanofi-Aventis) address, as well as those of Juvderm (cross-linked hyaluronic acid, Allergan) and Restylane (hyaluronic acid, Medicis), with the exception of lips.


"In my opinion, the M product is the best of the four Ellans strengths. Initially, many physicians may continue to use HAs or calcium hydroxylapatite fillers because they are safe, easy to use and a known entity. Physicians may be initially wary of the unknown, and as with any new product, it may take some time for injectors to get used to Ellans and actually choose the filler as a first-line treatment," Dr. Pirayesh says. "It would behoove physicians to overcome their cautious skepticism and give Ellans a try, because I believe they will be quickly convinced by the potential of this unique filler."


The same patient 18 months after the one-month touch-up. No additional touch-ups were performed between the one-month touch-up and the 18-month photo. Approximately 1.78 mL of Ellans-M was used for treatment of the nasolabial fold.

MIX AND MATCH Dr. Gritzalas uses Ellans for nasolabial folds and cheek augmentation, and still uses other leading fillers for specific cosmetic indications, such as Macrolane (Q-Med, United Kingdom) for breast augmentation. Using Macrolane, Dr. Gritzalas performs breast augmentation procedures lasting up to 14 months, without touch-up treatments. However, the cosmetic effect of this procedure could last for up to four years with Ellans, Dr. Gritzalas says.

"The difference in longevity is simply astonishing, and, in my opinion, Ellans could be a true game-changer in aesthetic medicine.

"Aesthetic physicians could truly enter a new market here and challenge other specialties with this unique filler," Dr. Gritzalas says.

DISCLOSURES:
Both Drs. Pirayesh and Gritzalas are trainers in workshops for Ellans, but neither report any relevant financial interests.

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