Navigation Links
PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery

- Tissue Dissection System Represents Important Advance in Radiofrequency

Surgical Technologies -

PALO ALTO, Calif., July 24 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System combines the PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBlade(TM) 4.0, a low-temperature surgical cutting and coagulation tool. This tissue dissection system will be commercially available next month.

"With the introduction of the PlasmaBlade, general surgeons now have access to a single surgical tool that cuts tissue as precisely as a scalpel and controls bleeding as effectively as traditional electrosurgery without causing extensive collateral thermal damage to tissues," said John Tighe, chief executive officer of PEAK Surgical.

In preparation for the commercialization of the PEAK Surgery System, the company launched a redesigned corporate Web site, which can be accessed at The Web site provides detailed information about all of the components of the PEAK Surgery System, including a cart and wireless foot switch, as well as video, a brochure, fact sheets, product images, scientific literature and surgeon testimonials, among other information.

Benefits of the PlasmaBlade and PULSAR Generator

For decades, surgeons have relied on scalpels to cut skin and delicate tissues and used electrosurgical devices to cut and coagulate fat and other thicker, tougher tissues. Although scalpels precisely cut tissue, they do not control bleeding. Electrosurgical devices, on the other hand, cut efficiently and control bleeding but can cause extensive thermal damage to surrounding tissue. In cases where the risk of collateral damage or scarring from electrosurgery is considered to be unacceptable, surgeons must use both a traditional scalpel for cutting and an electrosurgery device for coagulation. The PlasmaBlade combines into a single surgical tool the precision of a scalpel and the bleeding control of a traditional electrosurgery device.

Unlike most radiofrequency-based surgical products that use continuous voltage waveforms to cut tissue, the PULSAR Generator supplies pulsed plasma-mediated electrical discharges through the PlasmaBlade. Because the radiofrequency is provided in short on-and-off pulses and the blade contains highly insulated electrodes, the PlasmaBlade cuts tissue at an average temperature that is half that of a conventional electrosurgery device and can be as low as 50 degrees Centigrade. This temperature reduction results in reduced heat transfer and half the damage to surrounding tissues compared with traditional electrosurgical devices. The PlasmaBlade also can dissect tissue in a wet or dry surgical field.

The pulsed plasma-mediated discharges and electrode insulation techniques were originally developed at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University.

"Surgeons typically must switch between a scalpel and a traditional electrosurgery device depending on the surgical field and type of tissue they are cutting," said Dr. Thomas M. Krummel, professor and chair of surgery at Stanford University School of Medicine. "I believe the PlasmaBlade has the potential to revolutionize the way surgery is performed because it eliminates the need to change from one surgical tool to another as a surgeon cuts through all types of soft tissue, including skin, fat and muscle. It also has the ability to cut in a wet or dry surgical field, an advancement over most electrosurgical tools in use today."

PlasmaBlade Study Results

Results of a preclinical surgical incision healing study of the PlasmaBlade presented in an oral presentation at the American College of Surgeons' Annual Clinical Congress in October 2007 demonstrated that it efficiently cut tissue with effective bleeding control and minimal thermal damage compared with standard surgical techniques. The PlasmaBlade reduced bleeding by 60 percent compared with a scalpel, while providing the same positive wound healing profile of minimal scarring and inflammation. In addition, surgical incision healing and strength were significantly improved with the PlasmaBlade compared with traditional electrosurgical devices.

Additional preclinical studies of the PEAK Surgery System are underway. PEAK Surgical is exploring the applicability of its technology across numerous surgical fields beyond general surgery, including cardiothoracic, gynecologic, plastic and reconstructive and neurosurgery. The company believes the technology may have applications in more than 2 million surgical procedures each year.

About PEAK Surgical, Inc.

PEAK Surgical, Inc. is a medical device company that has developed the PEAK(R) Surgery System, a new tissue dissection system based on a proprietary technology that represents an evolutionary leap in the advancement of radiofrequency surgical technologies. The PEAK Surgery System consists of the PEAK PlasmaBlade(TM) 4.0, a disposable cutting tool that offers the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage, and the PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlade. The PEAK Surgery System is cleared for use in general surgery in the United States. The company is exploring the applicability of this technology across additional surgical fields, including cardiothoracic, gynecologic, plastic and reconstructive, and neurosurgery. For more information, please visit

SOURCE PEAK Surgical, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Pioneer(R) Surgical Technology, Inc. Announces the Market Launch of the SlimFuse(TM) Anterior Cervical Plate System
2. Healthcare Facility Managers Learn to Optimize Surgical Suites at 2008 ASHE Annual Conference
3. Studies Show USGI Medicals EndoSurgical Operating System(TM) Enables Incisionless Surgery to Reduce Gastric Pouch and Stoma After Gastric Bypass
4. Novare Surgical Wins Medical Design Excellence Award
5. Spine Surgeons at Pine Creek Medical Center Take the Lead in Utilizing Stem Cell Technologies in Surgical Procedures
6. CryoLifes BioGlue(R) Surgical Adhesive Receives European Approval for use in Browlift Cosmetic and Reconstructive Plastic Surgery
7. Simbionix Takes Non-Invasive GYN Surgical Training to the Next Level
8. USGI Medical Licenses Incisionless Surgery Technology to Intuitive Surgical
9. Pioneer(R) Surgical Technology Announces First Human Implants of its NuNec(TM) Cervical Arthroplasty Device
10. Gynecologic Oncologist, With Board Certification in GYN Oncology, OB/GYN, and Surgery Offers Women With Cancer the Newest Treatment Frontier: the Surgical Robot
11. STAAR Surgicals Collamer(R) IOL Designated as a New Technology Intraocular Lens by the Centers for Medicare and Medicaid Services
Post Your Comments:
(Date:11/27/2015)... , November 27, 2015 ... Growing popularity of companion diagnostics is ... cancer biomarkers market with pharmaceutical companies and ... companion diagnostic tests. . ... Complete report on global cancer biomarkers ...
(Date:11/25/2015)... , November 25, 2015 2 ... première fois les différences entre les souches bactériennes ... celles des êtres humains . Ces recherches ... et envisager la prise en charge efficace de ... diagnostiqués chez les chats .    --> ...
(Date:11/25/2015)... IN (PRWEB) , ... November 25, 2015 , ... ... (AMA) and the Organization of Black Aerospace Professionals (OPBAP) has been formalized with ... and other AMA team leaders met with OPBAP leaders Capt. Karl Minter and ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... The United ... recipient of the 2016 USGA Green Section Award. Presented annually since 1961, the USGA ... his or her work with turfgrass. , Clarke, of Iselin, N.J., is ...
Breaking Biology Technology:
(Date:10/23/2015)... DUBLIN , Oct. 23, 2015 Research ... of the "Global Voice Recognition Biometrics Market 2015-2019" ... --> --> The global voice recognition ... during 2014-2019. --> ... 2015-2019, has been prepared based on an in-depth market ...
(Date:10/22/2015)... Inc. (NASDAQ: AWRE ), a leading supplier of biometrics software ... September 30, 2015.  --> --> ... a decrease of 33% compared to $6.0 million in the same ... was $2.2 million, or $0.10 per diluted share, which compared to ... a year ago.  --> --> ...
(Date:10/22/2015)... , Oct. 22, 2015 About fingerprint ... fingerprint scan of an individual with the database to ... as arch, whorl, and loop. Pattern-based algorithms are used ... advances in technology, AFIS was introduced in 1986, which ... agencies to identify a criminal. Technavio,s analysts ...
Breaking Biology News(10 mins):