If you have patients complaining about having to come back month after month, year after year, for treatment of wrinkles or scars, then a new filler from Artes Medical, Artefill, which is currently seeking FDA approval, may be an answer to their problems. This injectable micro-implant, marketed as Artecoll outside the United States, has been used in more than 200,000 patients in Europe, South America, Mexico and Canada since 1994. How It Works According to the company’s Web site, Artefill is made of homogenous polymethylmethacrylate (PMMA) microspheres evenly suspended in a solution of partly denatured 3.5% collagen. It consists of 75% collagen solution and 25% PMMA microspheres. All microspheres are in the range of 32 to 40 microns and are completely round and smooth. Artecoll or Artefill contains the anesthetic lidocaine hydrochloride. When injected, it takes a patient 1 to 3 months to absorb the collagen carrier, and then the Artecoll collagen is replaced by the patient’s own collagen. The PMMA microspheres act as a stimulus for collagen formation. Each microsphere is surrounded and encapsulated by the patient’s collagen. Once the remodeling process is completed after 3 to 6 months, the augmentation area consists of about 75% of the patient’s collagen and 25% PMMA microspheres to form a pliable implant. To test its efficacy and safety, Artes Medical conducted a randomized, controlled, multicenter clinical trial at eight U.S. centers to compare Artecoll versus control (Zyderm and Zyplast) for four treatment areas: glabellar frowns, nasolabial folds, radial upper lip lines and mouth corners. Results, which were presented at an FDA panel hearing in February, showed that using masked observers’ ratings of photographs, using the Facial Fold Assessment Scale, there was a statistically significant difference between the Artecoll group and control group for nasolabial folds. The other three areas were not significantly different between the two groups. A secondary endpoint, success as rated by the investigators, showed a statistically significant difference in improvement in the Artecoll group over control at 3 and 6 months for all treatment sites. Results also showed no statistically significant difference in the safety of Artecoll versus the collagen control. How It’s Being Used Alastair Carruthers, F.R.C.P.C., who practices in Canada, has been using Artecoll since October 1998 and has been very happy with the success he’s seen so far. He’s been using the filler to treat everything from the nasolabial area to acne scarring. Patients with acne scars don’t want to be reminded about the scars and having to have them treated repeatedly, says Dr. Carruthers. They want to forget about their scars, so it makes sense to treat these patients with a filler that is going to give them long-term improvement. They don’t want to be coming back every 3 months for another treatment. With Artecoll, Dr. Carruthers treats patients two to three times, using a total of one to three syringes. A syringe is a 1/2 cc and Dr. Carruthers says a syringe costs a patient about $500 to $600. Another good candidate for Artecoll is a patient in his or her sixties who’s had a huge loss of volume on the face. Artecoll can’t make them look 20 years old again, but can provide significant improvement in correction of the volume lost. Injection Technique Dr. Carruthers says that injection technique is really the key to safely using Artefill. Doctors need to be properly trained in the injection technique, which is very different than for other fillers. During the FDA panel hearing in February, Dr. Steve Cohen, a Clinical Associate Professor at the University of California, San Diego, and Director of Craniofacial Surgery at the Children’s Hospital in San Diego, also said that the injection technique is important. Dr. Cohen, who is on the Medical Advisory Board for Artes Medical, said, “A tunneling technique is used and a deep dermal placement of the material is made just above the subcutaneous tissue. If a second injection is used, this is layered on top of the first one with the same type of tunneling technique.” Possible Complications Because Artefill is a permanent filler, Dr. Carruthers says it’s important to inform patients about the possibility that complications that are not yet known could arise years down the road. Dr. Carruthers says he always prefers to start patients with a temporary filler and then use Artecoll on patients when they understand the potential risks but really don’t want to have to keep coming back to his office for treatments. They want long-term results. “The biggest issue with injectibles is complications 10 to 15 years later,” explains Dr. Carruthers, adding that we clearly don’t yet know the long-term effects. Though, he adds, he has yet to see any significant adverse events. There have been reports of lumps or granulomas when Artecoll was used to treat lips, which will be a contraindication in the United States with Artefill. During the FDA panel, it was indicated that no ethnic patients were treated during the trials so there’s no data about this population, though the company said this was not a result of exclusion, but just who answered the ad to participate in the study. Dr. Carruthers has treated Asian and African skin and hasn’t encountered any differences. Find Out More To learn more about Artefill, which is expected to get FDA approval in early 2004, visit www.artefill.com, or call (858) 550-9999.
The Art of a New Filler
If you have patients complaining about having to come back month after month, year after year, for treatment of wrinkles or scars, then a new filler from Artes Medical, Artefill, which is currently seeking FDA approval, may be an answer to their problems. This injectable micro-implant, marketed as Artecoll outside the United States, has been used in more than 200,000 patients in Europe, South America, Mexico and Canada since 1994. How It Works According to the company’s Web site, Artefill is made of homogenous polymethylmethacrylate (PMMA) microspheres evenly suspended in a solution of partly denatured 3.5% collagen. It consists of 75% collagen solution and 25% PMMA microspheres. All microspheres are in the range of 32 to 40 microns and are completely round and smooth. Artecoll or Artefill contains the anesthetic lidocaine hydrochloride. When injected, it takes a patient 1 to 3 months to absorb the collagen carrier, and then the Artecoll collagen is replaced by the patient’s own collagen. The PMMA microspheres act as a stimulus for collagen formation. Each microsphere is surrounded and encapsulated by the patient’s collagen. Once the remodeling process is completed after 3 to 6 months, the augmentation area consists of about 75% of the patient’s collagen and 25% PMMA microspheres to form a pliable implant. To test its efficacy and safety, Artes Medical conducted a randomized, controlled, multicenter clinical trial at eight U.S. centers to compare Artecoll versus control (Zyderm and Zyplast) for four treatment areas: glabellar frowns, nasolabial folds, radial upper lip lines and mouth corners. Results, which were presented at an FDA panel hearing in February, showed that using masked observers’ ratings of photographs, using the Facial Fold Assessment Scale, there was a statistically significant difference between the Artecoll group and control group for nasolabial folds. The other three areas were not significantly different between the two groups. A secondary endpoint, success as rated by the investigators, showed a statistically significant difference in improvement in the Artecoll group over control at 3 and 6 months for all treatment sites. Results also showed no statistically significant difference in the safety of Artecoll versus the collagen control. How It’s Being Used Alastair Carruthers, F.R.C.P.C., who practices in Canada, has been using Artecoll since October 1998 and has been very happy with the success he’s seen so far. He’s been using the filler to treat everything from the nasolabial area to acne scarring. Patients with acne scars don’t want to be reminded about the scars and having to have them treated repeatedly, says Dr. Carruthers. They want to forget about their scars, so it makes sense to treat these patients with a filler that is going to give them long-term improvement. They don’t want to be coming back every 3 months for another treatment. With Artecoll, Dr. Carruthers treats patients two to three times, using a total of one to three syringes. A syringe is a 1/2 cc and Dr. Carruthers says a syringe costs a patient about $500 to $600. Another good candidate for Artecoll is a patient in his or her sixties who’s had a huge loss of volume on the face. Artecoll can’t make them look 20 years old again, but can provide significant improvement in correction of the volume lost. Injection Technique Dr. Carruthers says that injection technique is really the key to safely using Artefill. Doctors need to be properly trained in the injection technique, which is very different than for other fillers. During the FDA panel hearing in February, Dr. Steve Cohen, a Clinical Associate Professor at the University of California, San Diego, and Director of Craniofacial Surgery at the Children’s Hospital in San Diego, also said that the injection technique is important. Dr. Cohen, who is on the Medical Advisory Board for Artes Medical, said, “A tunneling technique is used and a deep dermal placement of the material is made just above the subcutaneous tissue. If a second injection is used, this is layered on top of the first one with the same type of tunneling technique.” Possible Complications Because Artefill is a permanent filler, Dr. Carruthers says it’s important to inform patients about the possibility that complications that are not yet known could arise years down the road. Dr. Carruthers says he always prefers to start patients with a temporary filler and then use Artecoll on patients when they understand the potential risks but really don’t want to have to keep coming back to his office for treatments. They want long-term results. “The biggest issue with injectibles is complications 10 to 15 years later,” explains Dr. Carruthers, adding that we clearly don’t yet know the long-term effects. Though, he adds, he has yet to see any significant adverse events. There have been reports of lumps or granulomas when Artecoll was used to treat lips, which will be a contraindication in the United States with Artefill. During the FDA panel, it was indicated that no ethnic patients were treated during the trials so there’s no data about this population, though the company said this was not a result of exclusion, but just who answered the ad to participate in the study. Dr. Carruthers has treated Asian and African skin and hasn’t encountered any differences. Find Out More To learn more about Artefill, which is expected to get FDA approval in early 2004, visit www.artefill.com, or call (858) 550-9999.
If you have patients complaining about having to come back month after month, year after year, for treatment of wrinkles or scars, then a new filler from Artes Medical, Artefill, which is currently seeking FDA approval, may be an answer to their problems. This injectable micro-implant, marketed as Artecoll outside the United States, has been used in more than 200,000 patients in Europe, South America, Mexico and Canada since 1994. How It Works According to the company’s Web site, Artefill is made of homogenous polymethylmethacrylate (PMMA) microspheres evenly suspended in a solution of partly denatured 3.5% collagen. It consists of 75% collagen solution and 25% PMMA microspheres. All microspheres are in the range of 32 to 40 microns and are completely round and smooth. Artecoll or Artefill contains the anesthetic lidocaine hydrochloride. When injected, it takes a patient 1 to 3 months to absorb the collagen carrier, and then the Artecoll collagen is replaced by the patient’s own collagen. The PMMA microspheres act as a stimulus for collagen formation. Each microsphere is surrounded and encapsulated by the patient’s collagen. Once the remodeling process is completed after 3 to 6 months, the augmentation area consists of about 75% of the patient’s collagen and 25% PMMA microspheres to form a pliable implant. To test its efficacy and safety, Artes Medical conducted a randomized, controlled, multicenter clinical trial at eight U.S. centers to compare Artecoll versus control (Zyderm and Zyplast) for four treatment areas: glabellar frowns, nasolabial folds, radial upper lip lines and mouth corners. Results, which were presented at an FDA panel hearing in February, showed that using masked observers’ ratings of photographs, using the Facial Fold Assessment Scale, there was a statistically significant difference between the Artecoll group and control group for nasolabial folds. The other three areas were not significantly different between the two groups. A secondary endpoint, success as rated by the investigators, showed a statistically significant difference in improvement in the Artecoll group over control at 3 and 6 months for all treatment sites. Results also showed no statistically significant difference in the safety of Artecoll versus the collagen control. How It’s Being Used Alastair Carruthers, F.R.C.P.C., who practices in Canada, has been using Artecoll since October 1998 and has been very happy with the success he’s seen so far. He’s been using the filler to treat everything from the nasolabial area to acne scarring. Patients with acne scars don’t want to be reminded about the scars and having to have them treated repeatedly, says Dr. Carruthers. They want to forget about their scars, so it makes sense to treat these patients with a filler that is going to give them long-term improvement. They don’t want to be coming back every 3 months for another treatment. With Artecoll, Dr. Carruthers treats patients two to three times, using a total of one to three syringes. A syringe is a 1/2 cc and Dr. Carruthers says a syringe costs a patient about $500 to $600. Another good candidate for Artecoll is a patient in his or her sixties who’s had a huge loss of volume on the face. Artecoll can’t make them look 20 years old again, but can provide significant improvement in correction of the volume lost. Injection Technique Dr. Carruthers says that injection technique is really the key to safely using Artefill. Doctors need to be properly trained in the injection technique, which is very different than for other fillers. During the FDA panel hearing in February, Dr. Steve Cohen, a Clinical Associate Professor at the University of California, San Diego, and Director of Craniofacial Surgery at the Children’s Hospital in San Diego, also said that the injection technique is important. Dr. Cohen, who is on the Medical Advisory Board for Artes Medical, said, “A tunneling technique is used and a deep dermal placement of the material is made just above the subcutaneous tissue. If a second injection is used, this is layered on top of the first one with the same type of tunneling technique.” Possible Complications Because Artefill is a permanent filler, Dr. Carruthers says it’s important to inform patients about the possibility that complications that are not yet known could arise years down the road. Dr. Carruthers says he always prefers to start patients with a temporary filler and then use Artecoll on patients when they understand the potential risks but really don’t want to have to keep coming back to his office for treatments. They want long-term results. “The biggest issue with injectibles is complications 10 to 15 years later,” explains Dr. Carruthers, adding that we clearly don’t yet know the long-term effects. Though, he adds, he has yet to see any significant adverse events. There have been reports of lumps or granulomas when Artecoll was used to treat lips, which will be a contraindication in the United States with Artefill. During the FDA panel, it was indicated that no ethnic patients were treated during the trials so there’s no data about this population, though the company said this was not a result of exclusion, but just who answered the ad to participate in the study. Dr. Carruthers has treated Asian and African skin and hasn’t encountered any differences. Find Out More To learn more about Artefill, which is expected to get FDA approval in early 2004, visit www.artefill.com, or call (858) 550-9999.
