Minimally invasive system smooths cellulite for up to 3 years

WASHINGTON – The key to treating cellulite may be as simple as cutting a tiny tether.

Vertical bundles of fibrous septae that run through subdermal fat and anchor the skin seem to cause the dimples and bulges that annoy up to 95% of women. Releasing those fibers with a minimally invasive instrument causes an immediate smoothing of the skin – an improvement that appears to last for at least 3 years, according to data presented at the annual meeting of the American Academy of Dermatology.

“At 3 years, the data are remarkably consistent,” said Dr. Michael Kaminer of Yale University, New Haven, Conn. “No one was unsatisfied with the result, and in fact, 93% of the patients were still satisfied or very satisfied. So I would say this meets the criteria of something that is reasonable to offer to our patients.

The Cellfina system can treat up to 30 dimples in a single hour-long session, according to Dr. Kaminer, who discussed the procedure in a video interview. The procedure costs anywhere from $2,500-$6,000 per session, depending on how many dimples are treated.

The device consists of a circular area that provides enough suction to elevate the skin over each dimple. One disposable click-in module contains a 22-gauge multibore needle that delivers local anesthetic. After the anesthetic is delivered, a second module clicks into place. This contains an 18-gauge probe tipped with a very small triangular blade. Inserted 5-6 mm below the skin, the probe can be pivoted back and forth, cutting the septae under the dimple. This releases their constricting effect on the skin, which immediately rebounds and appears smooth. The system does not remove any fat.

Cellfina’s earlier data earned it a 2-year Food and Drug Administration clearance for cellulite treatment. The data presented at the meeting confirm its effect at 3 years, Dr. Kaminer said, and form the basis of an application for a 3-year clearance.

The follow-up study comprised 45 women who had undergone the procedure and were reevaluated by several means: a blinded physician rating of before and after pictures, and a 1- 5 point patient self-evaluation scale, with a change of at least 1 point rated as “satisfactory.”

These women represented all six Fitzpatrick skin types. They were a mean of 40 years old at baseline and had a mean body mass index of 25 kg/m².

Independent, blinded physicians were given before-and-after photos of all patients and asked to identify which photo showed change. All of the physicians correctly identified all of the “after” photos.

“This was not a subtle change they were seeing in the pictures,” Dr. Kaminer said. “It’s a very, very noticeable improvement that a physician who doesn’t treat cellulite would recognize as something having been done.”

At the 1-year follow-up, patients reported an average improvement of 2 points on the severity scale. This was largely maintained at 3 years; 42 patients (93%) remained satisfied. Of the entire group, 19 patients said they were very satisfied, 23 were “satisfied,” and the rest were neutral. No one was unsatisfied, he noted.

“What this means is that about half of patients had an amazing result and the rest had a very good result,” Dr. Kaminer said. He added that none of the women had requested any retreatment. “Most felt like the improvement they experienced was good enough not to need more.”

In fact, he said, the 3-year follow-up photos seem to show that the contours of the treated areas continued to improve. “It certainly looks that way. We have no idea why this would be,” he said but suggested that once women feel better about the appearance of their legs and rear, they may be more motivated to make such beneficial lifestyle changes as improved diet and regular exercise.

The system has mostly been used for buttock cellulite, but that’s expanding. Dr. Kaminer said. “We are treating a lot of outer thighs now, and we’re starting to move into anterior thighs and seeing excellent results.”

He added that the procedure is very safe and quite easy for patients to tolerate. Postprocedural pain is minimal and managed with nonprescription acetaminophen. Aftercare consists only of wearing a light compression garment – like a body shaper – for a week after the procedure. Adverse events included slight ecchymosis that cleared rapidly; one patient experienced scratching for pruritus.

Some women, however, will experience a residual firmness in treated areas. It’s not clear what this is, Dr. Kaminer said, but it recedes spontaneously over 6-12 months. “If it’s really bothering them, you can inject a little steroid into it. It can sometimes go away with massage.”

Informing patients about the possibility is key, he added. “If you tell them they might experience it, it’s really not a big deal to them.”

Dr. Kaminer received financial benefits during the initial development and deployment of Cellfina, but said he has no financial ties to the company now.

msullivan@frontlinemedcom.com

WASHINGTON – The key to treating cellulite may be as simple as cutting a tiny tether.

Vertical bundles of fibrous septae that run through subdermal fat and anchor the skin seem to cause the dimples and bulges that annoy up to 95% of women. Releasing those fibers with a minimally invasive instrument causes an immediate smoothing of the skin – an improvement that appears to last for at least 3 years, according to data presented at the annual meeting of the American Academy of Dermatology.

“At 3 years, the data are remarkably consistent,” said Dr. Michael Kaminer of Yale University, New Haven, Conn. “No one was unsatisfied with the result, and in fact, 93% of the patients were still satisfied or very satisfied. So I would say this meets the criteria of something that is reasonable to offer to our patients.

The Cellfina system can treat up to 30 dimples in a single hour-long session, according to Dr. Kaminer, who discussed the procedure in a video interview. The procedure costs anywhere from $2,500-$6,000 per session, depending on how many dimples are treated.

The device consists of a circular area that provides enough suction to elevate the skin over each dimple. One disposable click-in module contains a 22-gauge multibore needle that delivers local anesthetic. After the anesthetic is delivered, a second module clicks into place. This contains an 18-gauge probe tipped with a very small triangular blade. Inserted 5-6 mm below the skin, the probe can be pivoted back and forth, cutting the septae under the dimple. This releases their constricting effect on the skin, which immediately rebounds and appears smooth. The system does not remove any fat.

Cellfina’s earlier data earned it a 2-year Food and Drug Administration clearance for cellulite treatment. The data presented at the meeting confirm its effect at 3 years, Dr. Kaminer said, and form the basis of an application for a 3-year clearance.

The follow-up study comprised 45 women who had undergone the procedure and were reevaluated by several means: a blinded physician rating of before and after pictures, and a 1- 5 point patient self-evaluation scale, with a change of at least 1 point rated as “satisfactory.”

These women represented all six Fitzpatrick skin types. They were a mean of 40 years old at baseline and had a mean body mass index of 25 kg/m².

Independent, blinded physicians were given before-and-after photos of all patients and asked to identify which photo showed change. All of the physicians correctly identified all of the “after” photos.

“This was not a subtle change they were seeing in the pictures,” Dr. Kaminer said. “It’s a very, very noticeable improvement that a physician who doesn’t treat cellulite would recognize as something having been done.”

At the 1-year follow-up, patients reported an average improvement of 2 points on the severity scale. This was largely maintained at 3 years; 42 patients (93%) remained satisfied. Of the entire group, 19 patients said they were very satisfied, 23 were “satisfied,” and the rest were neutral. No one was unsatisfied, he noted.

“What this means is that about half of patients had an amazing result and the rest had a very good result,” Dr. Kaminer said. He added that none of the women had requested any retreatment. “Most felt like the improvement they experienced was good enough not to need more.”

In fact, he said, the 3-year follow-up photos seem to show that the contours of the treated areas continued to improve. “It certainly looks that way. We have no idea why this would be,” he said but suggested that once women feel better about the appearance of their legs and rear, they may be more motivated to make such beneficial lifestyle changes as improved diet and regular exercise.

The system has mostly been used for buttock cellulite, but that’s expanding. Dr. Kaminer said. “We are treating a lot of outer thighs now, and we’re starting to move into anterior thighs and seeing excellent results.”

He added that the procedure is very safe and quite easy for patients to tolerate. Postprocedural pain is minimal and managed with nonprescription acetaminophen. Aftercare consists only of wearing a light compression garment – like a body shaper – for a week after the procedure. Adverse events included slight ecchymosis that cleared rapidly; one patient experienced scratching for pruritus.

Some women, however, will experience a residual firmness in treated areas. It’s not clear what this is, Dr. Kaminer said, but it recedes spontaneously over 6-12 months. “If it’s really bothering them, you can inject a little steroid into it. It can sometimes go away with massage.”

Informing patients about the possibility is key, he added. “If you tell them they might experience it, it’s really not a big deal to them.”

Dr. Kaminer received financial benefits during the initial development and deployment of Cellfina, but said he has no financial ties to the company now.

msullivan@frontlinemedcom.com

WASHINGTON – The key to treating cellulite may be as simple as cutting a tiny tether.

Vertical bundles of fibrous septae that run through subdermal fat and anchor the skin seem to cause the dimples and bulges that annoy up to 95% of women. Releasing those fibers with a minimally invasive instrument causes an immediate smoothing of the skin – an improvement that appears to last for at least 3 years, according to data presented at the annual meeting of the American Academy of Dermatology.

“At 3 years, the data are remarkably consistent,” said Dr. Michael Kaminer of Yale University, New Haven, Conn. “No one was unsatisfied with the result, and in fact, 93% of the patients were still satisfied or very satisfied. So I would say this meets the criteria of something that is reasonable to offer to our patients.

The Cellfina system can treat up to 30 dimples in a single hour-long session, according to Dr. Kaminer, who discussed the procedure in a video interview. The procedure costs anywhere from $2,500-$6,000 per session, depending on how many dimples are treated.

The device consists of a circular area that provides enough suction to elevate the skin over each dimple. One disposable click-in module contains a 22-gauge multibore needle that delivers local anesthetic. After the anesthetic is delivered, a second module clicks into place. This contains an 18-gauge probe tipped with a very small triangular blade. Inserted 5-6 mm below the skin, the probe can be pivoted back and forth, cutting the septae under the dimple. This releases their constricting effect on the skin, which immediately rebounds and appears smooth. The system does not remove any fat.

Cellfina’s earlier data earned it a 2-year Food and Drug Administration clearance for cellulite treatment. The data presented at the meeting confirm its effect at 3 years, Dr. Kaminer said, and form the basis of an application for a 3-year clearance.

The follow-up study comprised 45 women who had undergone the procedure and were reevaluated by several means: a blinded physician rating of before and after pictures, and a 1- 5 point patient self-evaluation scale, with a change of at least 1 point rated as “satisfactory.”

These women represented all six Fitzpatrick skin types. They were a mean of 40 years old at baseline and had a mean body mass index of 25 kg/m².

Independent, blinded physicians were given before-and-after photos of all patients and asked to identify which photo showed change. All of the physicians correctly identified all of the “after” photos.

“This was not a subtle change they were seeing in the pictures,” Dr. Kaminer said. “It’s a very, very noticeable improvement that a physician who doesn’t treat cellulite would recognize as something having been done.”

At the 1-year follow-up, patients reported an average improvement of 2 points on the severity scale. This was largely maintained at 3 years; 42 patients (93%) remained satisfied. Of the entire group, 19 patients said they were very satisfied, 23 were “satisfied,” and the rest were neutral. No one was unsatisfied, he noted.

“What this means is that about half of patients had an amazing result and the rest had a very good result,” Dr. Kaminer said. He added that none of the women had requested any retreatment. “Most felt like the improvement they experienced was good enough not to need more.”

In fact, he said, the 3-year follow-up photos seem to show that the contours of the treated areas continued to improve. “It certainly looks that way. We have no idea why this would be,” he said but suggested that once women feel better about the appearance of their legs and rear, they may be more motivated to make such beneficial lifestyle changes as improved diet and regular exercise.

The system has mostly been used for buttock cellulite, but that’s expanding. Dr. Kaminer said. “We are treating a lot of outer thighs now, and we’re starting to move into anterior thighs and seeing excellent results.”

He added that the procedure is very safe and quite easy for patients to tolerate. Postprocedural pain is minimal and managed with nonprescription acetaminophen. Aftercare consists only of wearing a light compression garment – like a body shaper – for a week after the procedure. Adverse events included slight ecchymosis that cleared rapidly; one patient experienced scratching for pruritus.

Some women, however, will experience a residual firmness in treated areas. It’s not clear what this is, Dr. Kaminer said, but it recedes spontaneously over 6-12 months. “If it’s really bothering them, you can inject a little steroid into it. It can sometimes go away with massage.”

Informing patients about the possibility is key, he added. “If you tell them they might experience it, it’s really not a big deal to them.”

Dr. Kaminer received financial benefits during the initial development and deployment of Cellfina, but said he has no financial ties to the company now.

msullivan@frontlinemedcom.com