Intuitive Announces FDA Clearance of da Vinci Single Port for Transanal Local Excision/Resection

Rhea-AI Summary

Intuitive (NASDAQ: ISRG) has received FDA clearance for its da Vinci Single Port (SP) surgical system for transanal local excision/resection procedures. This minimally invasive surgery is performed through natural orifices, avoiding abdominal incisions. The clearance expands the system's capabilities in colorectal surgery, building on previous FDA approvals from November 2024. The da Vinci SP system features three multi-jointed instruments and a high-definition articulating camera through a single entry point, designed specifically for narrow body cavities. The system addresses challenges in laparoscopic transanal surgery, including surgeon ergonomics and reaching upper rectal lesions. With over 500 peer-reviewed publications supporting its safety and efficacy, the da Vinci SP is also approved in Europe, Japan, and Korea. Intuitive has facilitated nearly 17 million procedures and trained approximately 90,000 surgeons in its 30-year history.

Positive

• FDA clearance expands da Vinci SP's capabilities into new surgical procedures
• System enables minimally invasive surgery without external scarring
• Strong clinical validation with over 500 peer-reviewed publications
• Broad international approval across Europe, Japan, and Korea
• Large installed base with 90,000 trained surgeons and 17 million procedures performed

Negative

• None.

Insights

Medical Technology Expert

Intuitive expands da Vinci SP capabilities with FDA clearance for natural orifice colorectal procedures, avoiding external scarring and enhancing surgical precision.

Intuitive's latest FDA clearance for the da Vinci Single Port (SP) system represents a significant technical advancement in minimally invasive colorectal surgery. The clearance specifically enables transanal local excision/resection, allowing procedures to be performed through natural orifices without abdominal incisions.

The engineering behind the SP system addresses several critical challenges in colorectal surgery. Its architecture enables control of three multi-jointed instruments and a high-definition articulating camera through a single entry point. This design specifically overcomes limitations of conventional laparoscopic transanal surgery, including ergonomic challenges for surgeons, difficulties reaching upper rectal lesions, and the ability to work circumferentially when necessary.

Most importantly, this technology enables surgeons to avoid external scarring by operating through natural orifices, contrasting with conventional transabdominal approaches that typically require multiple incisions and often rectum removal. The clinical significance is highlighted by Dr. Laila Rashidi's comment that this technology may help adapt some transabdominal procedures to transanal approaches for appropriate lesions.

This clearance builds upon Intuitive's existing colorectal portfolio, complementing the da Vinci 5 and Xi systems to offer a more comprehensive set of surgical options. With over 500 peer-reviewed publications supporting the SP system's safety and efficacy, this platform has demonstrated substantial clinical validation across multiple specialties, including its previous clearances in urology, otolaryngology, and thoracoscopic procedures.

For Intuitive, this represents the latest milestone in their 30-year history of robotic-assisted technology development, during which surgeons have performed nearly 17 million procedures using their systems worldwide.

Healthcare Regulatory Expert

FDA clearance expands Intuitive's addressable market in colorectal surgery through natural orifice procedures, demonstrating regulatory execution and platform expansion.

This FDA clearance for Intuitive's da Vinci SP system represents a strategic regulatory achievement that builds upon the company's methodical approach to indication expansion. The clearance for transanal local excision/resection follows the November 2024 authorization for transabdominal procedures including low anterior resection, total mesorectal excision, colectomy, abdominoperineal resection, and sigmoidectomy.

From a regulatory perspective, this sequential clearance approach demonstrates Intuitive's expertise in navigating the FDA process for expanding indications. The robotic platform now covers a comprehensive range of colorectal procedures, addressing various clinical needs through different surgical approaches.

The clearance is particularly significant as it enables natural orifice surgery, avoiding external incisions required in conventional approaches. This aligns with broader healthcare trends toward less invasive procedures that potentially offer improved recovery profiles and patient experiences.

The substantial body of clinical evidence cited (over 500 peer-reviewed publications) indicates Intuitive has invested significantly in generating the safety and efficacy data necessary to support regulatory submissions across multiple indications. This evidence-based approach has facilitated clearances across diverse specialties including urology, otolaryngology, and now expanded colorectal applications.

The international regulatory approvals in Europe, Japan, and Korea further validate the platform's global acceptance. As Intuitive reaches its 30th anniversary milestone with nearly 17 million procedures performed and nearly 90,000 surgeons trained, this clearance reinforces the company's continued commitment to expanding minimally invasive surgical options across specialties.

SUNNYVALE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that the U.S. Food and Drug Administration (FDA) cleared the da Vinci Single Port (SP) surgical system for transanal local excision/resection, a form of minimally invasive surgery performed through a natural orifice to avoid abdominal surgical incisions for select procedures. This clearance extends the da Vinci SP’s capabilities in colorectal surgery, building upon procedures previously cleared by the FDA in November 2024, which include transabdominal procedures - low anterior resection, total mesorectal excision, colectomy, abdominoperineal resection, and sigmoidectomy.

Intuitive engineered the da Vinci SP system to navigate in narrow body cavities requiring precise access, such as lower pelvis and rectal procedures. Its design and architecture support access to rectal anatomy by allowing surgeons to control up to three multi-jointed instruments and a high-definition articulating camera through a single entry point to work freely in the smaller space.

Da Vinci SP also helps mitigate challenges inherent with laparoscopic transanal minimally invasive surgery, such as surgeon ergonomics, reaching lesions in the upper rectum, and working circumferentially, or “upside-down,” when needed.

“With FDA’s clearance of the da Vinci SP system for transanal local resection, surgeons have a new option in colorectal surgery to positively impact patient outcomes,” said Intuitive Executive Vice President and Chief Medical Officer Myriam Curet, MD. “Da Vinci SP represents a major leap forward for minimally invasive colorectal surgery, supporting surgeons in better preserving healthy tissue and accelerating patient recovery.”

The da Vinci SP system helps enable surgeons to dissect, suture, and excise through a natural orifice, avoiding external scarring for patients, unlike conventional transabdominal rectal resection, which typically requires multiple incisions and removal of the rectum.

“Using the da Vinci SP will help me adapt some of my transabdominal low anterior resections to transanal surgeries for appropriate lesions,” said Laila Rashidi, M.D., of MultiCare Tacoma General Hospital in Tacoma, Wash.

This clearance adds to Intuitive’s colorectal portfolio, designed to meet the diverse needs of colorectal surgeons. With da Vinci 5 and da Vinci Xi, Intuitive provides colorectal surgeons with a broad, integrated offering to support a spectrum of colorectal interventions.

A growing body of evidence, including more than 500 peer-reviewed publications to date, supports the safety, efficacy, and outcomes associated with the da Vinci SP system. The FDA has previously cleared the da Vinci SP system for certain urology procedures, including simple prostatectomy, as well as transoral otolaryngology and general thoracoscopic procedures. The da Vinci SP system is also approved for use in Europe, Japan, and Korea for a range of procedures spanning multiple surgical disciplines.

2025 marks Intuitive’s 30^th year developing robotic-assisted technology with the goal of improving patient outcomes, improving patient and care team experience, increasing access to minimally invasive care, and lowering the total cost to treat. In Intuitive's first three decades, surgeons have performed nearly 17 million procedures using our technology, and nearly 90,000 surgeons have been trained to use our systems.

Contact: Megan Elliott, Intuitive
Global Public Affairs
corp.comm@intusurg.com
1-669-222-9899

About Intuitive

Intuitive (NASDAQ: ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic surgery. Our technologies include the da Vinci surgical system and the Ion endoluminal system. By uniting advanced systems, progressive learning, and value-enhancing services, we 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 disease is identified early and treated quickly, so that patients can get back to what matters most.

About da Vinci Surgical Systems

There are several models of the da Vinci Surgical System. The da Vinci surgical systems are designed to help surgeons perform minimally invasive surgery and offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels, and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

Important Safety Information

For Important Safety Information, indications for use, risks, full cautions, and warnings, please refer to the associated da Vinci user manual(s).

FAQ

What is the new FDA clearance for Intuitive's (ISRG) da Vinci SP system?

The FDA has cleared Intuitive's da Vinci SP system for transanal local excision/resection, allowing minimally invasive surgery through natural orifices without abdominal incisions.

How does the da Vinci SP system benefit colorectal surgery patients?

The system enables surgery without external scarring, supports better preservation of healthy tissue, and may accelerate patient recovery through minimally invasive techniques.

What are the key features of Intuitive's (ISRG) da Vinci SP surgical system?

The system features three multi-jointed instruments and a high-definition articulating camera through a single entry point, designed for narrow body cavities like lower pelvis and rectal procedures.

How many procedures have been performed using Intuitive's (ISRG) technology?

Nearly 17 million procedures have been performed using Intuitive's technology, with approximately 90,000 surgeons trained on their systems over 30 years.

Where is Intuitive's (ISRG) da Vinci SP system currently approved?

The da Vinci SP system is approved in the United States, Europe, Japan, and Korea for various surgical procedures across multiple disciplines.