Professionisti del settore sanitario

PEAK PlasmaBlade Device

Overview

Powered by the PULSAR® II Generator, the PEAK PlasmaBlade® is a soft tissue dissection instrument that uses very brief, high-frequency pulses of radiofrequency (RF) energy to induce electrical plasma along the edge of a thin (12.5μm), 99.5% insulated electrode.

Espandi tutto

Overview

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.

 

The Technology

Peak Plasmablade Devices

Pulsar II Generator