PEAK Surgical announces positive results from two PRECISE Clinical Studies for breast cancer diagnosis

May 3 2010

PEAK Surgical, Inc. today announced positive results from two of its ongoing PRECISE Clinical Studies (Pulsed Plasma Radiofrequency to ReduCe Thermal Injury and Improve Surgical HEaling) demonstrating the clinical benefits of using the PEAK PlasmaBlade® tissue dissection device during lumpectomy for the diagnosis of breast cancer.  The study findings were presented at the 11th Annual Meeting of the American Society of Breast Surgeons (ASBS) in poster sessions.

"The PRECISE series of clinical studies were designed to demonstrate the impact of reduced thermal injury and post-operative recovery, and the data from the lumpectomy studies reiterates findings from previous PRECISE presentations," said Deanna J. Attai, MD, FACS, Director, Center for Breast Care, Inc., Burbank, Calif. "The reduced thermal impact of the PlasmaBlade technology has the potential to not only improve recovery, but also reduce the need for repeat procedures to ensure clean margins are obtained. In contrast, traditional electrosurgical devices can damage tissue and make it difficult to accurately assess the cancer status of the tissue."

Data from one study demonstrated the PlasmaBlade offers several major improvements over the standard of care (i.e., scalpel and traditional electrosurgery devices) in areas related to the pathological diagnosis of breast cancer. Benefits include significantly reduced thermal injury depth at the sample margin, amount of char on the slide, epithelial damage at the margin and overall improved diagnostic quality of pathologic specimen.

In the second study, researchers used automated imprint cytology (IC) in conjunction with the PlasmaBlade and assessed the relative thermal injury to breast tissue specimens and the ability to retrieve undamaged cells for IC analysis. They concluded that epithelial cells could be harvested by IC from the PlasmaBlade sample margins with less thermal injury and enhanced overall margin quality compared to traditional electrosurgery.

Additionally, a presentation by Dr. Attai on surgery and margin assessment using PEAK Surgical's pulsed plasma technology was included in a pre-meeting CME-accredited course on advancements in technology used to diagnose and treat diseases of the breast.

"The results of these PRECISE studies demonstrate the clinical benefits of the PEAK PlasmaBlade in helping to improve breast cancer diagnosis and treatment," said John Tighe, president and CEO of PEAK Surgical. "The PlasmaBlade clearly has an important role in the continuum of surgical care needed to treat breast cancer, including lumpectomy, mastectomy and breast reconstruction, due to its ability to dissect delicate tissue and improve clinical outcomes."