PEAK Surgical Announces Results from PRECISE Breast Oncology Studies Demonstrating PEAK PlasmaBlade's Key Role in Diagnosis and Treatment of Breast Cancer

LAS VEGAS and PALO ALTO, Calif., April 30 /PRNewswire/ -- 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."

Comparison of PEAK PlasmaBlade to Standard of Care in Open Breast Biopsy(1)

While traditional electrosurgery, which is associated with significant thermal injury to surrounding tissue during cutting and coagulation, has been previously shown to negatively affect wound healing and postoperative course, no prior studies have investigated the impact of thermal injury on pathological margin analysis in breast cancer.

The aim of this PRECISE study was to examine the effect of the PlasmaBlade on the pathological analysis of biopsy-proven breast malignancies (i.e. ductal and invasive carcinomas), compared to traditional electrosurgery. Sixteen female subjects were randomized to either the standard of care treatment arm (i.e. scalpel and traditional electrosurgery devices) or the PlasmaBlade treatment arm for open lumpectomy of their suspected breast malignancy.

Results showed:

• Histological analysis demonstrated that use of the PlasmaBlade reduced thermal injury depth to the excised specimen by 67 percent compared to traditional electrosurgery (117.8+/-120.3 micron vs. 351.9+/-137.3 micron, p< 0.001).
• Subjectively, scores obtained for char amount, epithelial margin damage and effect on diagnosis revealed that use of the PlasmaBlade improved these values by 25 percent, 38 percent, and 33 percent, respectively (1.1+/-0.4 vs. 1.5+/-0.5, p<0.01; 1.3+/-0.5 vs. 2.0+/-0.5, p=0.02; 1.0+/-0.0 vs. 1.5+/-0.8, p=0.11).  Overall, samples excised with the PlasmaBlade received a 29 percent higher histological quality score than traditional electrosurgery samples (3.3+/-0.5 vs. 5.0+/-1.2; p<0.005).
• Operative time, estimated blood loss and excised sample size for both treatment arms were equivalent. Additionally, post-operatively, skin scar width and quality were equivalent for scalpel and PlasmaBlade incisions at six weeks following surgery.

PlasmaBlade for the Evaluation of Breast Cancer Surgical Specimens(2)

Approximately 20 to 50 percent of malignant breast lump excisions using traditional electrosurgery result in positive margin status, requiring surgical re-excision and analysis. Traditional margin evaluation relies upon histological examination of paraffin embedded tissue or imprint cytology (IC). However, traditional electrosurgical devices impart thermal injury to within 1-2 mm of the margin, destroying nuclear grading information and degrading fine tissue architecture. While IC can evaluate surgical specimens intra-operatively for residual malignancy, this technique requires an experienced cytopathologist for interpretation and sample quality is limited by extensive electrosurgical artifacts.

The aim of this PRECISE study was to assess the relative thermal injury to the excised tissue and the ability to retrieve undamaged cells for IC analysis with the PlasmaBlade compared to the traditional electrosurgical (ES) device. Nine female subjects with an established diagnosis of palpable invasive ductal carcinoma underwent excision and six standard margin faces were examined via IC and compared to calibrated scalpel margins. Evaluation of thermal injury depth of the margin was conducted blindly against the true and calibrated margins; analysis was conducted using a proprietary diagnostic software algorithm.

Results showed:

• The mean thermal injury depth of calibrated positive margins for electrosurgery was 410.59 micron (Max 1802.28) and 125.83 micron (Max 512.73) for PlasmaBlade. At the true negative margin, these values were 296.59 micron (Max 948.88) and 221.60 micron (708.97), respectively.
• The automated analysis demonstrated that IC of the calibrated margins cut with PlasmaBlade could be analyzed using automated microscopy, because the fluorescent staining pattern and the shapes and sizes of the harvested nuclei were sufficiently similar to cells harvested by a cold scalpel.
• High resolution fluorescence analysis of the cells harvested by IC demonstrated minimal thermal injury compared to ES and H&E analysis showed the cells could be graded for identification of single cancer cells.

About PEAK Surgical, Inc. and the PEAK® Surgery System

PEAK Surgical, Inc. is a medical device company that has developed the PEAK® Surgery System, a new tissue dissection system based on a proprietary technology that represents an important advance in radiofrequency surgical technologies. The PEAK Surgery System consists of the PEAK PlasmaBlade®, a family of disposable cutting devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage, and the PULSAR® Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlade. The PEAK Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures in the United States, and for use in general surgery in the European Union. It was launched in the United States in July 2008 and has been used by U.S. surgeons on more than 20,000 patients, including general, gynecologic, orthopedic and plastic and reconstructive surgeries. For more information, please visit www.peaksurgical.com.

(1) "A Randomized Controlled Trial of the PEAK PlasmaBlade(TM) in Open Breast Biopsy Compared to Scalpel and Traditional Electrosurgery" [insert authors]. Presented by Peter L. Naruns, M.D. and Ankur Sangoi, M.D., El Camino Hospital, Mountain View, CA at the 2010 ASBS Annual Meeting, Las Vegas, NV.

(2) "A Prospective Controlled Trial of the PEAK PlasmaBlade(TM) in the Evaluation of Breast Cancer Surgical Specimens with Touch Prep." [insert authors] Presented by Sarah L. Blair, M.D., University

SOURCE PEAK Surgical, Inc.