Dive Brief:
- Medtronic said Wednesday it has filed for 510(k) clearance to expand the use of its Hugo surgical robot to general and gynecological indications.
- The Food and Drug Administration cleared the device in urologic procedures late last year. Expanding the label would position Medtronic to compete with Intuitive Surgical in more indications.
- An “increased contribution from Hugo” helped Medtronic grow U.S. medical surgical sales 8% in the fourth quarter of its financial year, CFO Thierry Piéton said on an earnings call Wednesday.
Dive Insight:
Hugo is Medtronic’s challenger to Intuitive’s market-leading da Vinci robots. Six years after Medtronic unveiled the device, the FDA cleared Hugo for use in the U.S. for the first time in December. The initial FDA clearance only covered urological procedures, restricting Medtronic to a subset of the surgeries performed using da Vinci robots.
Medtronic has filed for FDA clearance in general surgeries, including hernia repair, and in gynecologic specialties. The indications covered by the filings currently account for most surgeries performed in the U.S. using Intuitive’s da Vinci robots.
U.S. surgeons used da Vinci robots in about 2 million procedures last year. General surgery accounted for 1.25 million of the procedures, followed by the 468,000 gynecological surgeries that were enabled by da Vinci robots. Urology was the smallest of the three main areas of da Vinci use, accounting for 201,000 procedures.
Unlocking more indications could support increased use of a device that has begun contributing to Medtronic’s sales growth. Hugo is impacting Medtronic’s medical surgical portfolio, CEO Geoff Martha told analysts on the earnings call Wednesday. He added that worldwide procedure volume growth is two to three times the market rate. The company is installing more devices in the U.S., Martha said.
Medtronic has yet to provide a timeline for receiving 510(k) clearance in the new indications. While Medtronic disclosed the 510(k) filings this week, Martha said on the earnings call that the company applied for clearance in the additional indications in late April.
The push into new indications is part of Medtronic’s broader effort to expand its robotic capabilities. Medtronic also submitted a 510(k) filing for a vessel-sealing technology that works with Hugo and received clearance for a mesh used in robotic-assisted ventral hernia repair.
