Sapheon has filed with the FDA the first module of its premarket approval application for VenaSeal Sapheon, a device used for treating varicose veins. The system, which already has CE mark approval in Europe, is undergoing an investigational device exemption trial in the U.S.
Sapheon received $19.8 million from investors to further develop a device that injects an adhesive into varicose veins to seal them. After a small incision, an ultrasound is used to guide a catheter to the affected vein, which is treated with drops of the glue. Post-treatment medication and compression garments are not needed, the company says. A pivotal study could be completed next summer.
Immediate post-mastectomy reconstruction with autologous tissue is an option even if the patient will undergo radiation treatment, according to a study in the Annals of Plastic Surgery. Similar percentages of women with free-flap breast reconstruction had to undergo revision whether or not they received post-reconstruction radiotherapy, but the University of Pennsylvania study was not large enough to achieve statistical significance for that comparison. Post-radiotherapy volume loss was more likely in bilateral surgery patients who received perforated flap reconstruction than in those who received muscle-sparing free transverse rectus abdominis myocutaneous flaps.
Cranial reconstruction for a Pakistani girl attacked by the Taliban, facial reconstruction for a mutilated Afghan woman and a full face transplant for a 37-year-old man whose face was destroyed in an accidental shooting are among the plastic surgery wonders making recent headlines.
Operation Smile and Smile Train will partner on a project in Rwanda to repair cleft palates and facial deformities. Through the initiative, dubbed Rwanda Smiles, the charities aim to eliminate a backlog of cleft palate repairs by 2017. Volunteers will identify and treat people who need surgery and train local health care providers to give ongoing care.