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FDA Clearance For jioima Vaporflex And Legato Electrosurgical Probes



11/9/2016 11:09:52 AM

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IRVINE, Calif. & KARLSRUHE, Germany--(BUSINESS WIRE)--joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally-invasive spinal surgery, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Vaporflex® and Legato® electrosurgical probes with radiowave technology for open and endoscopic spine surgery.

“Spinal surgeons are now enabled to perform the range of joimax® procedures with even more flexibility and ergonomics in the USA as well. This way we further enhance surgical interventions in endoscopic minimally-invasive spinal surgery.”

The joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue. All Vaporflex® and Legato® probes use radio frequency which is generated by high oscillating electrical current received from a commercially available RF generator.

The new Vaporflex® system is optimized for versatile use due to different lengths, diameters and probe tips to allow endoscopic transforaminal and interlaminar procedures. It is both compatible and cleared also for the use with all Endovapor®/SurgiMax® and SurgiMax® Plus electrosurgical units and enables an easy swap of the Triggerflex® to the new Vaporflex® system. The bipolar Vaporflex® probes can easily be adopted to the complete range of joimax® systems. joimax® offers all its probes in a kit containing a sterilization tray, the hand piece as well as a shaft and a connection cable.

The monopolar and bipolar Legato® probes support the rhizotomy procedures with the existing Multiuse® and both newly launched products MultiZYTE® RT for Facet Joint Denervation and MultiZYTE® SI for SI Joint Therapy.

“Both the Vaporflex® and Legato® probes are ready for several generations of radiofrequency generators,” said Wolfgang Ries, CEO and founder of joimax®. “Spinal surgeons are now enabled to perform the range of joimax® procedures with even more flexibility and ergonomics in the USA as well. This way we further enhance surgical interventions in endoscopic minimally-invasive spinal surgery.”

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® RT (e.g. for rhizotomy) and with MultiZYTE® SI for SI-Joint therapy or with EndoLIF® and Percusys® for endoscopic minimally-invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions - under local or full anesthetic - via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

joimax® Inc.
Melissa Brumley
001 949 859 3472
Melissa.brumley@joimaxusa.com


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