Novel polycaprolactone dermal filler gains popularity in Europe

A revolutionary new filler product known as Ellansé (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. Ellansé 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 Ellansé 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."

FOUR STRENGTHS Ellansé 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.

"Ellansé 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.

Ellansé 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.