ROSWELL, Ga.--(BUSINESS WIRE)--May 1, 2013--Plasma Surgical, creator of the PlasmaJet®, an advanced energy medical device designed as a safe and effective alternative to traditional electrosurgery instruments, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for its flagship product. In addition to its previous indications for cutting and coagulation of tissue in open and laparoscopic surgical procedures, the PlasmaJet can now be marketed to include the removal of soft tissue by vaporization.
Because the unique plasma energy delivered by the PlasmaJet was engineered to treat tissue without the more intense effects of an electrical current, it offers surgeons a new tool to vaporize targeted tissue while minimizing impact to surrounding structures. Surgeons across multiple specialties often face the challenge of carefully removing troublesome lesions in various locations of the body through vaporization or ablation procedures. For some patient cases, surgeons might even avoid operating on certain tissues and structures without having a tool like the PlasmaJet available. PlasmaJet’s expanded labeling allows for potential uses of the device in thousands of more surgical cases where efficient vaporization capabilities are essential.
“This is a major milestone in recognizing the PlasmaJet as a safe and effective device for the removal of soft tissue by vaporization,” said Rick Morello, President & CEO, Plasma Surgical. “Our plasma technology has provided surgeons with access to an important tool and alternative to traditional cutting and coagulation devices since 2008, and we are excited to expand the PlasmaJet’s functionality for physicians worldwide.” Surgeons from the United States and Europe have used the PlasmaJet in a variety of clinical areas including gynecology, oncology, and plastic surgery. Currently, there are 14 peer-reviewed journal publications on the PlasmaJet covering pre-clinical and clinical studies performed by investigators from multiple specialties.
“Having a surgical tool that can cut, vaporize or coagulate with one instrument by varying the distance of the tip from tissue is a big advance,” said Richard P. Marvel, M.D., director of the Center for Pelvic Pain at Annapolis. “The energy is controlled and quickly dissipates causing minimal spread to adjacent tissues”.
Mr. Simon Butler-Manuel, M.D., M.B.B.S. (Lon), F.R.C.S., F.R.C.O.G., R.C.O.G., a Consultant Gynaecological Oncologist at the Royal Surrey County Hospital NHS Foundation Trust in the United Kingdom added, “This is a real step forward. In the PlasmaJet, we really have not only a truly multifunctional tool, but a device that it is eminently controllable, and allows for both vaporization and dissection whilst giving the user superb control especially when operating near sensitive structures.” The product will be showcased this year at several congresses including: ACOG - American Congress of Obstetricians and Gynecologists, New Orleans, LA. May 4-8, 2013 ESGE - European Society Gynae Endoscopy, Berlin, Germany. October 16-19. 2013 ESGO - European Society Gynaecological Oncology, Liverpool, UK. October 19-22, 2013 AAGL - American Association Gynecologic Laparoscopists. Washington DC. Nov 10-14, 2013
About Plasma Surgical
Plasma Surgical is harnessing plasma technology to make a true difference in the way surgical and therapeutic care is delivered to patients. The company’s flagship product, the PlasmaJet® system, is an advanced energy device for open and laparoscopic surgical procedures. Designed for efficient cutting, coagulation and removal of soft tissue by vaporization, PlasmaJet offers surgeons an important tool to treat structures carefully, especially when tissue preservation and minimal thermal effect are essential for the patient. Founded on world-class research in plasma physics in 1999, the company is headquartered in Atlanta and has offices in the United Kingdom and France. For more information, please visit www.plasmasurgical.com.