BellaSeno GmbH, a company specializing in medical 3D printing technologies with ISO 13485 certification, has published positive results from clinical studies on its resorbable implants. No serious complications or implant-related problems occurred after one year in 19 patients treated as part of a breast augmentation revision in Australia and seven patients with pectus excavatum correction. The studies confirm that resorbable scaffolds made of polycaprolactone (PCL) can be a promising alternative to conventional silicone implants.
The studies, which were conducted as single-arm interventional studies, evaluated the safety and performance of the implants. The focus was on post-operative safety, quality of life and volume replacement by the implants. The results showed that there were no complications such as capsular contractures, calcifications, oil nodules, infections, tissue necrosis or wound healing problems. In addition, no removal or replacement of the scaffolds was necessary in any case. The Independent Safety Monitoring Commission judged the observed events to be within the expected range for such procedures.
“This is a very encouraging one-year clinical outcome,” said Mohit Chhaya, CEO of BellaSeno. “The data confirm that our resorbable scaffolds do not only meet the desired safety criteria but also show an improvement of patients´ quality of life. We now have a very strong clinical data set to initiate a pivotal study of our resorbable breast scaffolds in the U.S. and Europe. We will also expand the use of our scaffolds to primary breast augmentation and lumpectomy and also provide a final two-year follow-up next year.”
Based on this data, BellaSeno plans to start a pivotal study in Europe and the USA. In addition, the areas of application are to be expanded to include primary breast augmentation and lumpectomies. A final two-year report is expected next year. The results underline the potential of additively manufactured, resorbable implants as a safe and effective alternative in medical care.
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