Intuitive earns CE mark for single-port robot while lining up next multi-port FDA nod

Intuitive Surgical’s is more than a one-track mind. Case in point: In the same breath that it announced the European clearance of one of its robotic surgery systems, the company also shared that it has submitted a brand-new system for review in the U.S.

Intuitive offered both updates this week while reporting its full-year 2023 financial results—which had already been previewed during a presentation at the J.P. Morgan Healthcare Conference in San Francisco earlier this year.

The product updates were new, however. In the finalized earnings release Tuesday, Intuitive announced the CE mark approval of its single-port platform, while CEO Gary Guthart, Ph.D., revealed in a subsequent call with investors that the company has submitted the latest iteration of its multi-port technology to the FDA for review.

The single-port system, dubbed da Vinci SP, has racked up clearances in the U.S. in recent years allowing it to be used in urology and transoral otolaryngology procedures. The newly bestowed CE mark allows European surgeons to use the SP platform in an even wider range of surgeries: endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal and breast surgical procedures.

Intuitive said in the earnings release that it plans to begin a “measured rollout” of the system in a handful of major European countries throughout this year.

“Surgeons in Europe have long been at the forefront of robotic-assisted surgery and led the adoption of innovative care that offers meaningful patient benefits,” Dirk Barten, senior VP and general manager of E.U. commercial and marketing for Intuitive, said in a company LinkedIn post Wednesday. “With the introduction of the da Vinci SP system, Intuitive continues to provide the latest technology to surgeons and hospitals across Europe.”

The European approval comes after a particularly successful 2023 for the SP system: Guthart told investors on the Tuesday afternoon call that average utilization for the systems grew 15% for the year, boosted by 58% procedure growth in the fourth quarter alone, according to a transcript of the call.

The CEO also reported that Intuitive is in the process of submitting the SP system for additional FDA clearances in colorectal and thoracic indications and is aiming for regulatory approval in China.

Meanwhile, Guthart’s reveal on this week’s call that a new multi-port system could soon arrive in the U.S. stands in stark contrast to his comments at Intuitive’s JPM presentation just a few weeks ago, when he offered only a “no comment” when asked whether a new version of the flagship da Vinci multi-port robot was on tap for 2024.

In fact, the company submitted the da Vinci 5 for FDA review in August, Guthart said, and is now in the process of responding to some questions from the regulator. The timing of the system’s clearance and commercial launch “will depend on the time required to resolve these questions,” he said, adding that the FDA’s requests so far “fall within normal expectations for a submission of this type.”

The da Vinci 5 system is designed not only to improve accessibility and affordability of minimally invasive care for patients and healthcare providers, according to the CEO, but also to improve upon its predecessors, thanks to “hundreds of design changes.”

“As just one example, da Vinci 5 possesses four orders of magnitude greater processing power than our Generation 4 products,” Guthart said. “That means 10,000 times the processing power to gather data, improve sensing and deliver better digital and analytic performance.”

Once the multi-port system has secured its FDA nod, Intuitive will roll it out in a phased launch spanning several quarters, “giving us time to mature our supply and manufacturing processes for the new system,” per Guthart.