FDA approves new da Vinci system for colorectal surgery

Published 01/05/2025, 14:26
FDA approves new da Vinci system for colorectal surgery

SUNNYVALE, Calif. - Intuitive (ISRG), a $184.87 billion medical technology leader with a GREAT financial health rating according to InvestingPro, announced today that its da Vinci Single Port (SP) surgical system has received U.S. Food and Drug Administration (FDA) clearance for an additional procedure in the field of colorectal surgery. The da Vinci SP is now cleared for transanal local excision/resection, a technique that allows for minimally invasive surgery performed through the body’s natural orifices.

This approval, which follows a previous FDA clearance in November 2024 for various transabdominal procedures, enhances the da Vinci SP’s utility in colorectal surgeries. The system is engineered for precise access in narrow body cavities, particularly suitable for lower pelvis and rectal procedures. It facilitates the control of up to three multi-jointed instruments and a high-definition camera through a single entry point.

The da Vinci SP system aims to improve patient outcomes by enabling surgeons to perform complex dissections, suturing, and excisions transanally, which can help avoid external scarring associated with conventional transabdominal rectal resection. This approach typically requires multiple incisions and removal of the rectum.

Dr. Myriam Curet, Executive Vice President and Chief Medical Officer at Intuitive, stated that the da Vinci SP represents a significant advancement for minimally invasive colorectal surgery, potentially leading to better preservation of healthy tissue and quicker patient recovery.

Supporting this innovation, Dr. Laila Rashidi from MultiCare Tacoma General Hospital mentioned that the system would allow her to adapt certain transabdominal surgeries to transanal procedures for suitable lesions.

The da Vinci SP’s safety, efficacy, and outcomes are backed by over 500 peer-reviewed publications. The system has also been cleared for various urology, transoral otolaryngology, and general thoracoscopic procedures and is approved for use in Europe, Japan, and Korea for multiple surgical disciplines.

Celebrating its 30th anniversary, Intuitive has seen nearly 17 million procedures performed with its technology and has trained almost 90,000 surgeons worldwide.

The da Vinci Surgical Systems, including the da Vinci SP, are designed to aid minimally invasive surgery, providing surgeons with 3D high-definition vision and computer-assisted precision. This clearance expands Intuitive’s portfolio in colorectal surgery, which also includes the da Vinci 5 and da Vinci Xi systems.

This announcement is based on a press release statement from Intuitive. Currently trading at $515.80, Intuitive appears overvalued according to InvestingPro’s Fair Value analysis, though its strong financial metrics and market leadership position continue to attract investor interest. Access the full Pro Research Report, available for over 1,400 US stocks including Intuitive, for comprehensive valuation insights and expert analysis.

In other recent news, Intuitive Surgical reported first-quarter results that exceeded expectations in both revenue and earnings per share, driven by a notable 17% year-over-year increase in procedure volume. The company has raised its 2025 procedure growth guidance to a range of 15-17%, up from the previous 13-16%, reflecting continued momentum. However, the company anticipates a 170 basis point impact on gross margins due to tariffs, which could vary by plus or minus 30 basis points. Analysts from firms like Stifel, RBC Capital, Truist Securities, Piper Sandler, and Raymond James have adjusted their price targets, with most maintaining positive ratings despite these challenges.

RBC Capital adjusted its target to $605, citing manageable tariff risks and a positive outlook for the upcoming dV5 system launch. Truist Securities revised its target to $590, noting that the anticipated tariff impact aligns with expectations, while Piper Sandler and Raymond James also lowered their targets to $575 and $592, respectively, due to tariff-related pressures. Despite these adjustments, analysts emphasize Intuitive Surgical’s strong earnings performance and growth potential, with Piper Sandler maintaining an Overweight rating and Raymond James highlighting the company’s market leadership.

Stifel continues to maintain a Buy rating with a $670 target, emphasizing the importance of system placements for future growth. The analysts believe that Intuitive Surgical’s positive procedure growth and strategic system launches will support its long-term prospects. Overall, the firm’s robust performance and strategic initiatives are seen as key drivers for its future trajectory, despite near-term margin pressures from tariffs.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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