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PEAK PlasmaBlade Device

Overview

The PEAK® Surgery System includes PEAK PlasmaBlade® soft tissue dissection devices and the PULSAR® II Generator.

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® II Generator. PEAK PlasmaBlade devices offer the precision of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral tissue damage.1-3,* The PULSAR II 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 System

  • Compared to scalpel and traditional electrosurgery, demonstrated improved operating efficiency4,*
  • Compared to scalpel, reduces blood loss during skin incision1,*
  • Compared to traditional electrosurgery, reduced thermal injury depth2,*
  • Maintains its cutting effectiveness and hemostatic ability even when submerged in liquefied tissue or blood1,*
  • Operates at significantly lower temperatures than traditional electrosurgical technology (40 – 170°C vs. 200 – 350°C)5,**  
  • Simple set-up with plug-and-play functionality
  • Numerous surgical applications

Evidence of the PEAK PlasmaBlade performance within its intended use has been reported in numerous clinical and pre-clinical evaluations. Based on these studies, Medtronic believes that the PEAK PlasmaBlade may offer an effective alternative to the traditional scalpel or electrosurgical devices, potentially providing surgeons with better outcomes for their patients. Three separate, peer-reviewed, published studies have demonstrated equivalence in healed incision strength, inflammatory cell counts and healed scar width between scalpel and PEAK PlasmaBlade.1-3,* PEAK PlasmaBlade incisions have demonstrated significantly reduced thermal injury depth, inflammatory response and healed scar width, compared to traditional electrosurgery.2,*

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

  1. Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009;124(6):1849-1859.
  2. Ruidiaz ME, Messmer D, Atmodjo DY, et al. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011;128(1):104-111.
  3. Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative healing of rat fascia following incision with three surgical instruments. J Surg Res.2011;167(1):47-54.
  4. Data on file. VR-00083 study summary. 71-10-2454.
  5. Data on file. PEAK PlasmaBlade operating temperature study summary. 71-10-2475.

*   Performance has not been specifically established in all procedures.
** Operating temperature is a function of device settings, electrode configuration and treatment time.  Operating temperatures outside this range may be observed.

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THE TECHNOLOGY

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, the PEAK PlasmaBlade® 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® II Generator.

The PEAK PlasmaBlade uses less total energy and operates at significantly lower temperatures than traditional electrosurgical technology (40 – 170°C vs. 200 – 350°C).1,* 

Histology Image

PEAK PlasmaBlade device cut vs. traditional electrosurgery cut2

Clinical Benefits of PEAK PlasmaBlade System

The postoperative benefits of low thermal technology are well known. Compared with traditional electrosurgery, the decreased thermal injury profile of the PEAK PlasmaBlade, as determined by the zone of thermal coagulation necrosis, suggests that the device may be used in closer proximity to adjacent structures with less risk of thermal injury.2,** PEAK PlasmaBlade incisions have demonstrated significantly reduced thermal injury depth, inflammatory response and healed scar width compared to traditional electrosurgery3,** and demonstrated equivalence in healed incision strength, inflammatory cell counts and healed scar width compared to scalpel.2-4,**  

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. PEAK PlasmaBlade has been shown to dissect 24% (p=0.0002) more grams of tissue per minute than traditional electrosurgery, increasing surgical efficiency.5,** Compared to scalpel and traditional electrosurgery, PEAK PlasmaBlade patients reached 50% or normal diet by day 2 (median) vs. day 6.5 (median) for standard of care.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

  1. Data on file. PEAK PlasmaBlade operating temperature study summary. 71-10-2475.
  2. Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009;124(6):1849-1859.
  3. Ruidiaz ME, Messmer D, Atmodjo DY, et al. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011;128(1):104-111.
  4. Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative healing of rat fascia following incision with three surgical instruments. J Surg Res.2011;167(1):47-54.
  5. Data on file. VR-00065 study summary. 71-10-2453.
  6. Data on file. VR-00055 study summary. 71-10-2456.

*   Operating temperature is a function of device settings, electrode configuration and treatment time.  Operating temperatures outside this range may be observed. 
**  Performance has not been specifically established in all procedures.

PEAK PLASMABLADE DEVICES

PULSAR II GENERATOR