NuVasive has received CE mark approval for its Pulse spinal surgical automation platform. San Diego-based NuVasive touts its Pulse system as a first-of-its-kind technology designed to integrate radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring and spinal alignment tools into one platform.
According to a news release, Pulse is currently the only enabling technology platform capable of utilization in 100% of spine procedures and throughout the entire operating room workflow. The company said it increases safety, efficiency and procedural reproducibility while addressing several common clinical challenges in spine surgery.
With CE mark approval, NuVasive said clinical evaluations for Pulse are now underway across multiple countries throughout Europe. Pulse has held FDA approval in the U.S. since July 2018.
“The latest CE mark approval and clinical evaluations are key commercialization milestones for the Pulse platform and further our plan for an expanded global launch later this summer,” NuVasive EVP of global business units Massimo Calafiore said in the release. “There is a substantial opportunity for enabling technology adoption in spine surgery, and we are leveraging our expertise in proceduralization to introduce Pulse.
“This next generation of enabling technology has applications that can be utilized in every spine procedure.”
“In running a comprehensive spine program, I treat patients with a variety of complex spine pathologies and Pulse has utility in every surgical case,” said Dr. Jacques Müller-Broich, head of the spine specialty center and spinal orthopedics at University Hospital in Frankfurt, Germany. “The integration of C-arm image stitching and spinal alignment tools provide the ability to measure and correct alignment in real time—something I could not do with prior technologies. I am impressed by the results I am experiencing with Pulse and look forward to continue using this innovative platform in the OR.”
Editor’s Note: This article first appeared on sister publication Mass Device.
I am an orthopedic spine surgeon based in Frederick, Maryland, with a long experience in endoscopic procedures some of which I developed and currently being used globally. My endoscopic procedures include:
a. Endoscopic transforaminal decompression and percutaneous interbody fusion of the thoracic spine – 1995.
b. Transforaminal, Unilateral, Biportal, Endoscopic (UBE) lumbar decompression based on prior cadaver study comparing laminectomy vs transforaminal decompressions – 1996.
c. Endoscopic Trans-iliac approach to the lumbosacral junction – 1995.
d. Endoscopically assisted lumbar Interbody fusion (EndoLIF) – 2003
e. Endoscopic bilateral, tri-portal lamino-foraminoplasty – 2015.
I have also created a number of patents based on biologic implants, which may be applied endoscopically assisted. These have not been developed yet because of the biologic implant technology being far behind the ideas on which the patents were based. Raw materials for these biologic implants are now available, therefore development of these implants and their use for the treatment of spinal conditions as well as peripheral skeletal structures is highly probable.
I am now focused on applying an AI-guided, endoscopically assisted robotic navigation system for various spinal conditions, based on patient-specific protocols which I am developing. These protocols will, eventually, include implantation of these biologic implants via less than 10-millimeter incisions.
I hope we shall be able to get together and realize these visions.
Said G Osman, M.D.