NuVasive’s Early Beginnings! The Story told by its Founder!

June 2023 by Jim Marino–There are only a few parties who are familiar with the earliest beginnings of NuVasive.  I am one of them, as I was the founder and I gave the company its name.  Initially, the early inventive concepts that germinated NuVasive were developed from my interests in arthroscopy and spine surgery.  I was one of the early resident-trained arthroscopists in the early 1980’s and it was apparent that many procedural applications were a consequence of developing facilitating instrumentation to effect MIS peripheral joint surgery.  As a relatively newly minted orthopedist, my primary interest was in expanding arthroscopic applications (from knee to shoulder, to elbow, to ankle). 

My patient population was however largely composed of people with various degenerative lumbar disorders.  At that time there were only a few spine fellowship programs and I had confidence in my general surgical abilities, but I also realized that I needed to supplement my UCSD residency experience with as many hands-on AAOS and NASS training courses as possible.  I was fortunate enough to have one of the great pioneers in spine technologies, Arthur Steffee, mentor me in a pedicle screw instrumentation course.

In the late 80s and early 90s, NASS was a relatively small and intimate association of primarily orthopedic spine surgeons, and there were only a handful of commercial entities specializing in spine-related surgical products. This was in the era when segmental spine fixation (Cotrel – Dubousset technique) was rapidly being expanded from just a few spine centers to those orthopedists (most of whom were not fellowship trained) doing spine surgery in general.  The contrast between my MIS arthroscopic practice and my degenerative lumbar practice was enormous.  Spine surgery was and to some extent still is a relatively invasive surgical discipline.  Most of the surgical dissection involves the incising, retracting, and resection of healthy structures, to reach the pathology (buried deep below uninvolved muscles and bone).  Arthroscopy provided a means of reaching pathology-inaccessible joints with minimal collateral surgical injury, while the spine involved filleting the back.

I knew that there had to be a means of translating the principles of arthroscopy into spine surgery and I believed that enabling technology alone with innovative approaches would be the means.  At this time an orthopedist, Parviz Kambin, was advocating and teaching endoscopic disc decompression.  I was intrigued and traveled to the Graduate Hospital in Philadelphia, to learn directly from Kambin about his techniques in decompressing the disc and foramen endoscopically.  It was clear that Kambin 39’s insights were groundbreaking and that with time and innovation, even spine surgery would be amenable to safe and effective MIS techniques. Kambin relied upon the patient’s perception of nerve encroachment to protect against nerve injury. But as innovative as Kambin 39’s ideas were, I viewed the reliance on partially sedated patients (who might squirm during a delicate procedure), providing nerve monitoring, as less than optimum.  There needed to be advances in 1) patient-independent nerve monitoring, 2) precision navigation, and 3) cannula-mediated surgical intervention to afford spine surgery the opportunity that arthroscopy provided for peripheral joint surgery.  These were the three pillars of inventive development that led to the formation of NuVasive.

I initially had some ideas on articulating instrumentation, distally expanding cannulas with automated evoked EMG monitoring, and stereotaxic guidance using the image intensifier. Through a chance encounter, I was introduced to Drew Senyei, a non-practicing OB-GYN, who was a partner in Enterprise Partnership, a venture capital group in La Jolla.  In our first meeting, Drew seemed to be dozing off while I enthusiastically described what I viewed to be a potential revolution in spine intervention.  To his credit, he saw enough to suggest that we meet with his colleague, Joe Lacob, a partner in the prominent VC Group, Kleiner Perkins Caufield &Byers, (now Joe is more widely known for his principal ownership interest in the Golden State Warriors).  Drew and Joe were eventually able to persuade their partners (against the advice of their expert academic consultant) to invest in a new medical device enterprise, NuVasive, of which I was the initial President.  A patient of mine, Dan Ahlgren, provided the initial CAD representations of my ideas, using a home computer in my basement.  These ideas were circulated to prominent spine surgeon consultants throughout the country, and enough buy-in was obtained for the VCs to invest additional tranches of capital and begin building out the enterprise. Jim McKinley, NuVasive’s first CEO, was primarily responsible for creating the corporate structure and helping to raise additional capital. He was later succeeded by Alex Lukianov, who was very familiar with the spine market and had developed relationships with key spine surgeon thought leaders during his tenure at Medtronic. Alex became the “face of NuVasive” for much of its early commercialization.

My ambitions for NuVasive were excessively grand, I wanted to build a platform for minimally invasive spine surgery that rivaled the developments in MIS peripheral joint surgery.  In retrospect, they were too ambitious and I was thinking too much like a science-fiction writer and I was not sufficiently grounded in the realities of medical device development.  We were attempting to develop expanding electrified cannulas, stereotaxic C-arm-based navigation, automated nerve monitoring with proximity detection, a variety of endoscopic tools with various end-effects, and percutaneous facet fixation, while at the same time seeking to utilize a relatively new approach to an interbody fusion. I realized that the transforaminal/Kambin’s Triangle approach was too constrained for anticipated interbody work. I thought that a direct lateral retroperitoneal transpsoas approach might afford sufficient cross-sectional area to permit interbody decompression, expansion, and placement of interbody spacers (at that time, interbody devices were Class III devices and we were limited to sized femoral cortical allografts). Having such a positive experience with arthroscopic visualization, I believed that triangulated and biportal endoscopic visualization would be an important feature of intradiscal intervention as well.

The very first direct lateral transpsoas approach that I am aware of, occurred early in 1999. I performed the experimental procedure under experimental protocols on a patient of mine, who had pathology at L3-L4 and L4-L5. We utilized C-arm-based stereotaxic navigation, and conventional nerve monitoring (somatosensory evoked potentials and lower extremity EMGS) in addition to our newly developed automated evoked EMG nerve monitoring. I placed and employed an epidural electrode with escalating depolarization current, to generally assess threshold lower motor neuron function distal to the conus, as well as evoked EMGs from our electrified obturators and expanding cannulas. Because of my desire and insistence upon visualization, I also utilized an endoscopic approach via Kambin’s triangle to visually monitor the disc resection portion of the procedure and to add cancellous bone posterior to our mid-lateral to anterior annular approach.

The procedure was an enormous undertaking and while many talented engineers at NuVasive contributed to the development of a variety of enabling instrumentation, we were insufficiently experienced and I was “over my head” in trying to take on this surgical undertaking. Each level took six to seven hours, primarily because we did not have good tools for endoscopically removing the disc and I was trying to be meticulous about a complete discectomy. The patient woke up with dense bilateral femoral nerve deficits and genitofemoral and/or psoas pain. To this day, I am not certain as to why this occurred (as our nerve monitoring did not indicate a nerve violation), but my belief is that our transpsoas distally expanding cannula (which I was excluded from participating in its development, likely for fear that I would delay its completion) compressed the femoral nerves posterior to our approach and it was not designed to retract prior to removal. The length of nerve compression was a likely contributor to the neurologic and muscle insults. It may be of interest and irony to those understandably more familiar with NuVasive’s subsequent development of the open transpsoas approach (with the guidance of Dr. Luiz Pimenta) that the initial procedure that I performed was in a prone position using a Kambin frame, with the hips extended. Now, twenty-three to twenty-four years after that initial endoscopic procedure, Dr. Pimenta and others are popularizing the prone transpsoas approach for a variety of reasons. At the time that I conceived of the procedure, I believed that the dependency of the abdominal contents would move the peritoneal structures further anterior and that hip extension would provide for desired increased segmental lordosis.

That first procedure had an enormously adverse effect on my personal life. While the technical aspects of the procedure were, remarkably, attained (i.e., disc resection, bone grafting, and positioning of interbody cortical spacers with percutaneous facet screws at two levels), the procedure was a clinical failure due to the prolonged but transient femoral nerve dysfunction and persistent groin pain of the patient. Because of the poor clinical outcome, my unwillingness to continue without a thorough review of our procedural methods, and a personal dispute with management, NuVasive’s controlling interests lost confidence in my vision and clinical collaboration. The Board of Directors with NuVasive’s CEO, decided to remove me from the Board and sever my relationship with the company. This was not only a personal loss for me, but many of the visions that I had for NuVasive were no longer championed within the organization. I was enormously emotionally affected by my patient’s poor outcome. Largely as a consequence of this procedure and the efforts of at least one critical colleague to characterize my surgical approach as dangerously irrational, The Medical Board temporarily revoked my privileges. There were financial consequences as well, as an arbitrator concluded that the procedure was ill-conceived, and even though the patient signed an “Experimental Patient’s Bill of Rights” (as per experimental protocol mandated by an institutional review board) my liability was to the full extent of my insurance coverage. My malpractice premiums were raised to levels that made it financially “impossible” to continue practicing spine surgery. Because of an indemnification clause inserted into a renewal agreement (that I was unaware of) in an urgent payroll funding effort for NuVasive, I was “compelled” to surrender a considerable amount of my equity as well as royalties for several inventions, to comply with a severance agreement, or risk loss of my home, assets, and personal bankruptcy. It was a very painful lesson learned and I hope that other innovative surgeons who might read this will avoid making a similar catastrophic mistake.

In summary, the founding of NuVasive was an extraordinary opportunity and a very personal disappointment. There are many unnamed participants who made NuVasive’s success possible and quite a few of them have gone on to start or lead other companies in spine innovation (e.g., Jason Blain, Keith Valentine, Pat Miles, Jamil Elbanna, and others). I like to think that I had something positive to contribute to the field I love and tried very hard to innovate within. There have been many advances and there is much more to do yet to achieve the vision I had for endoscopic spine intervention. Outpatient percutaneous decompression and fusion will be a reality in the future, along with novel techniques for percutaneous controlled growth modulation (instead of fusion) for juvenile and adolescent scoliosis, and intervertebral disc regeneration. I wish I knew what I know now and was thirty to forty years younger so that I could help contribute to making this a reality, but that will be left for others to realize.

About Jim Marino

James (Jim) Marino is an orthopedic surgeon and recognized innovator of minimally invasive surgery. In 1997, Dr. Marino founded NuVasive, where he invented and developed highly disruptive spinal technology and procedures that recognized commercial success and ushered in the subspecialty of Minimally Invasive Spine Surgery (MISS). Since founding Trinity Orthopedics in 2004, Dr. Marino has continued to develop and commercialize surgical solutions designed to improve efficiency, reduce procedural costs, and improve patient outcomes.

###

Legal Advice: We are not responsible for any of the information, opinions, and concepts issued or published on our website by third parties articles. Likewise, since comments are allowed on our site, we are not responsible for them and reserve the right to delete offensive or demeaning comments and block and prevent future comments from their authors.