Intuitive receives FDA clearance of da Vinci SP for simple prostatectomy
28 Abril 2023 - 9:00AM
Intuitive (NASDAQ: ISRG), a global technology leader in minimally
invasive care and pioneer of robotic-assisted surgery, announced
that the Food and Drug Administration recently cleared the da Vinci
SP surgical system for simple prostatectomy as a representative
procedure, which expands the urologic surgical procedures cleared
by FDA.
Simple prostatectomy is a surgical procedure often used in
patients with benign prostatic hyperplasia (BPH) or enlarged
prostate. In this procedure, the surgeon removes the part of an
enlarged prostate that is blocking the flow of urine.
In the same action, the FDA cleared the da Vinci SP surgical
system for transvesical approach to simple and radical
prostatectomy using the da Vinci SP.
In radical prostatectomy, the surgeon removes the entire
prostate gland, most often for patients who have been diagnosed
with prostate cancer.
“The addition of simple prostatectomy and the transvesical
approach to prostatectomy to the da Vinci SP clearances expands the
existing urology indication for SP,” said Intuitive’s Chief Medical
Officer Myriam Curet, M.D.
“There is a growing body of clinical evidence on the use of the
SP system, and we look forward to continuing our efforts to safely
advance minimally invasive surgery,” said Curet.
The da Vinci SP system provides surgeons with robotic-assisted
technology designed for deep and narrow access to tissue in the
body. The ability to enter the body through a single, small
incision or through a natural orifice can provide a minimally
invasive experience for complex procedures.
The da Vinci SP system includes three, multi-jointed, wristed
instruments and a fully wristed three-dimensional (3D),
high-definition (HD) camera. The instruments and the camera all
emerge through a single cannula and are properly triangulated
around the target anatomy at the distal tip to avoid external
instrument collisions that can occur in narrow surgical
workspaces.
The system enables flexible port placement and excellent
internal and external range of motion (e.g., 360-degrees of
anatomical access) through the single SP arm. Surgeons control the
fully articulating instruments and the camera on the da Vinci SP
system, which uses the same surgeon console as the da Vinci
X and Xi systems.
Da Vinci SP can be used in Japan and Korea for a number of
procedures across several disciplines.
The FDA has cleared SP in the U.S. for urology and transoral
otolaryngology procedures, but it is not indicated for use in
general laparoscopic surgery procedures.
SP is part of Intuitive’s portfolio of surgical systems, now on
its fourth generation of innovative technology. The da Vinci X and
Xi are Intuitive’s multi-port surgical systems.
About IntuitiveIntuitive (Nasdaq: ISRG),
headquartered in Sunnyvale, California, is a global
leader in minimally invasive care and the pioneer of robotic
surgery. Our ground-breaking technologies include the da Vinci
surgical system and the Ion endoluminal system. Digital
intelligence allows us to unite our advanced systems, progressive
learning, and value-enhancing services to help physicians and their
teams optimize care delivery to support the best outcomes possible.
At Intuitive, we envision a future of care that is less invasive
and profoundly better, where diseases are identified early and
treated quickly, so patients can get back to what matters most. For
more information, please visit: https://www.intuitive.com/
Contact:Peper Long202 997 7373
Intuitive Surgical (NASDAQ:ISRG)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Intuitive Surgical (NASDAQ:ISRG)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024