, May 24, 2011
Interventional Spine, Inc. today announced the first use of its innovative Percutaneous Transforaminal Lumbar Interbody Fusion System, the PerX360 System, for the treatment of lumbar discogenic pain and instability.
Developed with the assistance of renowned surgeons in Europe and the United States, this new system is the first and only system in the world capable of providing surgeons the ability to perform a complete 360 lumbar interbody fusion via two 15mm percutaneous incisions. The system includes the Optiport access instrumentation and the Opticage interbody. The system was awarded CE Mark approval from its European Union Notified Body earlier this month.
The procedure was performed by Dr. Rudolf Morgenstern at the Teknon Medical Center in Barcelona, Spain, who was instrumental in the system's design and development.
"This is the way lumbar fusion surgeries will be performed in the future," commented Dr. Morgenstern. "The days of large incisions and long stays at the hospital for patients undergoing these types of surgeries are over. This system is very simple to use, can be performed with local anesthesia and should provide the patient a lower level of pain than today's highly invasive surgical approach. Also, at a time when most countries are undergoing healthcare cost pressures, the ability to do these types of procedures percutaneously, with local anesthesia and in an out-patient environment, will result in significant savings to governments and payors around the world," concluded Dr. Morgenstern.
Mr. Walter A. Cuevas, Chief Executive Officer of Interventional Spine commented, "We are very pleased with how this system performs. Working together with surgeons from two continents, our engineers have developed a revolutionary system that, in my opinion, will transform the way the world treats lumbar disc pain via fusion. The system involves a completely new approach to lumbar fusion, including both the instrumentation used to provide access to the spine and a unique interbody device that can be delivered in a truly percutaneous manner. We are grateful to all of the contributors who were involved in the development of this system."
Dr. David L. Greenwald, Neurosurgical Associates of St. Augustine, Florida, who was also involved in the development of the system, commented, "I can't wait for this system to be approved in the United States. By adapting new, state-of-the-art technologies to existing fusion procedures, Interventional Spine has developed a very simple approach to the standard-of-care lumbar fusion procedure. I believe this system will benefit health care providers, patients and payors alike, while providing the same tried and true benefits of a proven surgical procedure," concluded Dr. Greenwald.
Interventional Spine®, Inc. is a privately held company based in Irvine, California, that designs, develops and markets patented implantable devices for the spine that can be deployed via percutaneous techniques. Supported by the Company's unique product introduction systems, Interventional Spine's products provide benefits to patients, surgeons and hospitals alike. This system joins their current product offerings; the PERPOS® PLS System, the PERPOS® Percutaneous Cervical System, the PDS System and RENEW Allograft. More information on the Company and its products can be found at:
FOR FURTHER INFORMATION CONTACT:
Walter A. Cuevas
SOURCE Interventional Spine, Inc.