FDA clears Intuitive's new stapler for specific surgeries

SUNNYVALE, Calif. - Intuitive (NASDAQ:ISRG), known for its innovations in minimally invasive medical technology, has received U.S. Food & Drug Administration (FDA) clearance for its new SP SureForm 45 stapler. The device is designed for use with the company's da Vinci SP surgical system for thoracic, colorectal, and urologic procedures.

The SureForm 45 is a fully wristed stapler that incorporates SmartFire technology, which optimizes staple formation by continuously monitoring tissue compression. This feature is intended to improve staple line integrity and minimize tissue damage during surgery. The wristed design allows surgeons to operate from the da Vinci console with enhanced control, potentially reducing the need for an assistant and saving operating time.

Intuitive's Chief Medical Officer, Myriam Curet, M.D., stated that the integration of the SureForm 45 into single-port robotic surgery offers surgeons greater procedure control, which can contribute to faster patient recovery and less postoperative pain.

The da Vinci SP system stands out for allowing the control of three wristed instruments and a high-definition 3D camera through a single access point. This design helps to avoid external instrument collisions, which can be a challenge in constrained surgical spaces.

The da Vinci SP surgical system has been approved for various surgical procedures in Europe, Japan, Korea, and Taiwan. In the U.S., it is cleared for urology, transoral otolaryngology, colorectal, and thoracic procedures, with the SP SureForm 45 stapler now cleared for the latter three. However, it is not yet cleared for transoral otolaryngology procedures. With a robust gross profit margin of 67% and strong return on equity, Intuitive continues to demonstrate market leadership. For deeper insights into Intuitive's financial metrics and growth potential, investors can access the comprehensive research report available on InvestingPro.

Intuitive's portfolio includes several da Vinci surgical systems, with the da Vinci 5, Xi, and X representing the company's multi-port surgical systems now in their fifth generation.

This news is based on a press release statement and reflects the ongoing commitment of Intuitive to advance minimally invasive surgical technologies. The FDA's clearance of the SP SureForm 45 stapler represents another step in the company's efforts to enhance surgical efficiency and patient outcomes. While the stock currently trades near $523, analysts have set price targets ranging from $350 to $700, reflecting mixed opinions about its valuation. InvestingPro analysis suggests the stock is trading above its Fair Value, with 13 additional ProTips available to subscribers regarding the company's financial position and market performance.

In other recent news, Intuitive Surgical reported strong fourth-quarter results for 2024, surpassing expectations with a 10% and 24% beat on revenue and earnings per share (EPS), respectively. The company saw an 18% year-over-year growth in procedure volume, which is significant for future system placements. Intuitive Surgical has projected a 13-16% increase in procedure volume for 2025, aligning with its historical trend of setting conservative initial targets. Piper Sandler raised the company's stock target to $670, maintaining an Overweight rating, while RBC Capital Markets reaffirmed an Outperform rating with a $641 target. However, Erste Group downgraded the stock from Buy to Hold, citing potential negative impacts from new U.S. tariffs on Mexican imports, which could challenge the company's short-term earnings. Truist Securities adjusted the stock target to $605, maintaining a Buy rating, due to a contraction in the S&P multiple. Oppenheimer retained a Perform rating, noting concerns about market saturation in the U.S. and the premium pricing of the new da Vinci 5 system. Despite these varied analyst perspectives, Intuitive Surgical's strategic moves, including a significant distribution agreement in Europe, continue to draw attention.

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