Overview
The PEAK PlasmaBlade™ System includes PEAK PlasmaBlade disposable cutting devices and the PULSAR® Generator that offer the precision of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral thermal damage.
PEAK Surgery System
Based on innovative proprietary technology, the PEAK® Surgery System is a new tissue dissection system that represents an important advance in radiofrequency (RF) surgical technologies. It consists of the PEAK PlasmaBlade™ disposable cutting devices and the PULSAR® Generator. PEAK PlasmaBlade devices offer the precision of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral tissue damage. The PULSAR Generator supplies pulsed plasma RF energy to the PEAK PlasmaBlade devices with an intuitive interface that is easy to use.
Benefits of the PEAK PlasmaBlade System1-3
- Precision of a traditional scalpel
- Bleeding control of traditional electrosurgery technology
- Minimized thermal damage
- Ability to quickly and easily cut through all types of soft tissue, including skin, fat, and muscle
- Ability to operate in a wet or dry surgical field
- Simple set-up with plug-and-play functionality
- Broad surgical applications
Results of a PRECISE study (clinical surgical incision healing study) of the PEAK PlasmaBlade System demonstrated that it efficiently cut tissue with effective hemostasis and minimal thermal damage compared with standard surgical techniques.1 Based on these and other results from preclinical studies, Medtronic believes that the PEAK PlasmaBlade System may offer an effective alternative to the traditional scalpel or electrosurgical devices, potentially providing surgeons with better outcomes for their patients, including increased procedure efficiency, reduced surgical incision scarring, faster and stronger wound healing, and faster recovery compared to the standard of care.1-3
Indications for Use
The PEAK Surgery System is indicated for use in general, plastic and reconstructive, ENT, gynecologic, orthopaedic, arthroscopic, spinal, and neurological surgical procedures in the US. In the EU, the PEAK Surgery System is indicated for use in general surgery.
References/Footnotes
- Gurtner GC, et al. Results of the PRECISE Abdominoplasty Study: Improved Outcomes with the PEAK PlasmaBlade Compared to Scalpel and Traditional Electrosurgery. American College of Surgeons Annual Meeting, Chicago, IL, October 20, 2009.
- Data on file. ETR-00127.
- Data on file. ETR-00023.
PEAK PlasmaBlade Technology
Electrosurgery was invented in the early 20th century and became one of the most used surgical tools after William Bovie introduced his radiofrequency (RF) generator in 1926. Today, modern electrosurgical cutting tools use continuous RF waveforms, which thermally vaporize soft tissue through Joule heating and an electrical arc. This results in cutting and coagulation that leaves a wide zone of collateral thermal tissue damage.
The PEAK PlasmaBlade Difference
With proprietary pulsed plasma technology, PEAK PlasmaBlade™ System is revolutionizing the way surgery is performed today. Unlike most RF-based surgical equipment that use continuous voltage waveforms to cut tissue, the PEAK PlasmaBlade device is powered by pulsed plasma-mediated electrical discharges from the PULSAR® Generator.
The PEAK PlasmaBlade device receives RF energy in short pulses via a highly insulated cutting electrode, so it cuts at a much lower average temperature than conventional electrosurgery.6 Due to its lower temperatures, PEAK PlasmaBlade technology doesn’t cause the extensive collateral tissue damage often associated with traditional electrosurgery tools.
PEAK PlasmaBlade device cut vs. traditional electrosurgery cut2
Clinical Benefits of PEAK PlasmaBlade System
The postoperative benefits of low thermal technology are well known. Multiple human and animal clinical studies have demonstrated that a reduced thermal injury profile results in improved healing characteristics. Specific to the PEAK PlasmaBlade Surgery System, additional clinical research has demonstrated significant reduction in inflammatory cell counts; improvement in healed wound strength; and equivalent cutaneous scarring to the scalpel.3
Results of a PRECISE study (clinical surgical incision healing study) of the PEAK PlasmaBlade System demonstrated that it efficiently cut tissue with effective hemostasis and minimal thermal damage compared with standard surgical techniques.1 Based on these and other results from preclinical studies, Medtronic believes that the PEAK PlasmaBlade System may offer an effective alternative to the traditional scalpel or electrosurgical devices, potentially providing surgeons with better outcomes for their patients, including increased procedure efficiency, reduced surgical incision scarring, faster and stronger wound healing, and faster recovery compared to the standard of care.4-6
Origin of PEAK PlasmaBlade Technology
The PEAK PlasmaBlade System’s pulsed plasma-mediated discharges and electrode insulation techniques were originally invented and developed by Daniel Palanker and his team at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University. PEAK PlasmaBlade technology was developed further by PEAK Surgical for commercial purposes and acquired by Medtronic in 2011.
References/Footnotes
- Ruidiaz ME, Messmer D, Huang EJ, Atmodjo DY, Vose JG, Rosenberg HL, Kummel AC, Gurtner GC. Comparative Healing of Human Cutaneous Surgical Incisions Created by the PEAK PlasmaBlade, Conventional Electrosurgery, and a Standard Scalpel. Journal of Plastic and Reconstructive Surgery. 2011; 128(1): 104-111. Chronic wound healing study conducted in subjects undergoing abdominoplasty.
- Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative Healing of Rat Fascia Following Incision with Three Surgical Instruments. E-Published, January 2011. J Surg Res. 2011; 167(1): e47-54. Chronic wound healing study conducted in living rat model.
- Loh S, Carlson GA, Chang EI, Huang EJ, Palanker D, Gurtner GC. Comparative Healing of Surgical Incisions Created by the PEAK PlasmaBlade, Conventional Electrosurgery, and a Scalpel. Plas Reconstr Surg. 2009; 124(6):1849-1859. Chronic wound healing study conducted in living porcine model.
- Gurtner GC, et al. Results of the PRECISE Abdominoplasty Study: Improved Outcomes with the PEAK PlasmaBlade Compared to Scalpel and Traditional Electrosurgery. American College of Surgeons Annual Meeting, Chicago, IL, October 20, 2009.
- Data on file. ETR-00127.
- Data on file. ETR-00023.
PEAK PlasmaBlade Devices
Innovative PEAK PlasmaBlade™ devices are disposable surgical cutting and coagulation devices that offer the precision of a scalpel, the bleeding control of traditional electrosurgery, and minimized collateral tissue damage. Powered by the PULSAR® Generator, PEAK PlasmaBlade devices are based on proprietary pulsed plasma technology that limits heat diffusion and associated heat damage to surrounding tissues, resulting in less collateral damage and more precise tissue dissection compared to traditional electrosurgery.1-3
PEAK PlasmaBlade 4.0 cuts through all types of soft tissue
PEAK PlasmaBlade 4.0
The PEAK PlasmaBlade 4.0 cuts through all types of soft tissue, including skin, fat, and muscle. Applications include general surgery, orthopaedic and spinal surgery, reconstructive plastic surgery, pacemaker/ICD implants and revisions, and ENT surgery.
PEAK PlasmaBlade 4.0 IFU (PDF, 1.74 MB)
PEAK PlasmaBlade 3.0S with complete integrated suction and telescoping shaft
PEAK PlasmaBlade 3.0S
A highly versatile device, the PEAK PlasmaBlade 3.0S features complete integrated suction with a telescoping shaft for extended reach of up to 15cm. Applications include general surgery, orthopaedic and spinal surgery, reconstructive plastic surgery, pacemaker/ICD implants and revisions, and ENT surgery.
PEAK PlasmaBlade 3.0S IFU (PDF, 1.80 MB)
PEAK PlasmaBlade PLUS for precision dissection and coagulation
PEAK PlasmaBlade PLUS
The PEAK PlasmaBlade PLUS allows for precision tissue dissection and coagulation when needed. Applications include orthopaedic and spinal surgery.
PEAK PlasmaBlade PLUS IFU (PDF, 138 KB)
PEAK PlasmaBlade Needle with fine tip for ultra-precise procedures
PEAK PlasmaBlade Needle
With a fine needlepoint tip, the PEAK PlasmaBlade Needle is specifically designed for ultra-precise surgical procedures and working on very delicate skin, such as the face and eyelids. Applications include reconstructive plastic surgery, general surgery, orthopaedic and spinal surgery, pacemaker/ICD implants and revisions, and ENT surgery.
PEAK PlasmaBlade Needle IFU (PDF, 1.82 MB)
PEAK PlasmaBlade TnA for tonsillectomy and adenoidectomy
PEAK PlasmaBlade TnA
The PEAK PlasmaBlade TnA (Tonsil and Adenoid) has interchangeable tips specially designed for tonsillectomy and adenoidectomy procedures in ENT surgery.
PEAK PlasmaBlade TnA IFU (PDF, 3.84 MB)
References/Footnotes
- Ruidiaz ME, Messmer D, Huang EJ, Atmodjo DY, Vose JG, Rosenberg HL, Kummel AC, Gurtner GC. Comparative Healing of Human Cutaneous Surgical Incisions Created by the PEAK PlasmaBlade, Conventional Electrosurgery, and a Standard Scalpel. Journal of Plastic and Reconstructive Surgery. 2011; 128(1): 104-111. Chronic wound healing study conducted in subjects undergoing abdominoplasty.
- Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative Healing of Rat Fascia Following Incision with Three Surgical Instruments. E-Published, January 2011. J Surg Res. 2011; 167(1): e47-54. Chronic wound healing study conducted in living rat model.
- Loh S, Carlson GA, Chang EI, Huang EJ, Palanker D, Gurtner GC. Comparative Healing of Surgical Incisions Created by the PEAK PlasmaBlade, Conventional Electrosurgery, and a Scalpel. Plas Reconstr Surg. 2009; 124(6):1849-1859. Chronic wound healing study conducted in living porcine model.
PULSAR Generator
The PULSAR Generator enables surgeons to dial in the optimal amount of pulsed plasma radiofrequency energy for the PEAK PlasmaBlade device
The PULSAR® Generator is the cornerstone of the PEAK PlasmaBlade™ System. It supplies unrivaled waveforms for pulsed plasma-mediated surgery and powers the PEAK PlasmaBlade, a disposable cutting device that offers the precision of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral tissue damage.
Intuitive and Easy to Use
The PULSAR Generator is part of what makes the PEAK PlasmaBlade Surgery System simple and easy to use. It features:
- An intuitive user interface – design is based on direct feedback from surgeons and operating room staff
- "Plug-and-play" functionality – PEAK PlasmaBlade disposable surgical instruments communicate back and forth with the PULSAR Generator to program recommended settings, monitor Patient Return Electrode connectivity, and make slight power adjustments based on target tissue impedance