Intuitive Surgical has claimed a new FDA clearance for its smaller, single-arm robot, dubbed the da Vinci SP.
The agency added green lights that expand its reach in minimally invasive urologic procedures, namely operations to remove either a portion or the entire prostate gland.
They cover simple prostatectomies—where, for example, part of an enlarged prostate is excised to unblock the flow of urine in patients with benign prostate hyperplasia, or BPH. The system was previously cleared for radical procedures, where the entire organ is removed following a diagnosis of prostate cancer.
The clearance also adds the option of taking the transvesical route to the prostate for either operation, going directly through the bladder through a single incision to avoid damaging other organs.
The da Vinci SP, first OK’d by the FDA in 2014, delivers three jointed robotic instruments and a camera to the surgery site via a single tunnel. Surgeons control the device using the same console as Intuitive’s larger, multi-arm da Vinci X and Xi robots.
The da Vinci SP has also received FDA clearances for head and neck surgeries, performed through the mouth, but it has not yet been cleared for use in general laparoscopic surgeries in the rest of the body.
Intuitive recently reported a 26% year-over-year boom in da Vinci procedures being performed during the last quarter, as more patients return to pre-COVID healthcare routines. The company also reported an increase in its number of new equipment installations.
“While we do not expect this level of utilization growth to continue, we actively support our customers as they increase utilization of their da Vinci systems, which in turn lowers their per procedure costs,” Intuitive Chief Financial Officer Jamie Samath told investors on a company earnings call last week.