Vessel Sealer Curved receives FDA clearance

Rhea-AI Summary

Intuitive (Nasdaq: ISRG) has received FDA clearance for its new Vessel Sealer Curved, an advanced bipolar electrosurgical instrument designed for use with multiport da Vinci systems. The instrument represents a significant advancement in surgical technology, featuring a unique curved tip and fully wristed design for enhanced precision in minimally invasive procedures.

The device is FDA-cleared for sealing blood vessels up to 7mm in diameter and is notably the first of Intuitive's advanced energy instruments approved for lymphatic vessel transection. The curved jaw design follows natural anatomical contours, improving visibility and control in tight spaces. This milestone comes as Intuitive celebrates its 30th year in robotic-assisted technology, with nearly 17 million da Vinci procedures performed to date.

Positive

• First Intuitive instrument FDA-cleared for lymphatic vessel transection
• Enhanced precision with curved jaw design for better visibility and control
• Versatile functionality including sealing, cutting, grasping, and dissecting tissue
• Builds upon successful Vessel Sealer platform with improved features

Negative

• Not indicated for tubal sterilization procedures
• Limited to vessels up to 7mm in diameter

Insights

Medical Device Analyst

Intuitive's FDA clearance for Vessel Sealer Curved enhances their da Vinci system's capabilities in tight anatomical spaces.

Intuitive has secured FDA clearance for their new Vessel Sealer Curved instrument, representing a meaningful advancement in their advanced energy instrumentation lineup. This new tool is designed for use with their multiport da Vinci robotic surgery systems.

The key innovation here is the instrument's curved jaw design, which allows surgeons to more effectively navigate tight anatomical spaces and work around critical structures. This design follows natural anatomical contours, potentially improving surgical precision and visibility during complex procedures.

Notably, this is Intuitive's first advanced energy instrument to receive FDA clearance specifically for lymphatic vessel transection. The device combines multiple functions - sealing, cutting, grasping, and dissecting tissue - in a single instrument with a mechanical blade that cuts closer to the tip for enhanced dissection capabilities.

From a clinical perspective, this clearance expands Intuitive's addressable procedures. The instrument is cleared for grasping and blunt dissection, bipolar coagulation, and mechanical transection of blood vessels up to 7mm in diameter, along with lymphatic vessels and tissue bundles.

This product advancement aligns with Intuitive's three-decade focus on improving minimally invasive care. The company reports nearly 17 million da Vinci procedures performed to date and approximately 90,000 trained surgeons. The new instrument should help Intuitive maintain its leadership position in the robotic surgery market by addressing surgeon needs for greater precision in challenging anatomical environments.

Intuitive’s latest advanced energy instrument features a unique curved tip for enhanced precision

SUNNYVALE, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food & Drug Administration (FDA) has cleared its latest innovation in advanced energy instrumentation for use with its multiport da Vinci systems.

Vessel Sealer Curved is a fully wristed, advanced bipolar electrosurgical instrument designed to seal, cut, grasp, and dissect tissue. It is the first of Intuitive’s advanced energy instruments to receive FDA clearance for the transection of lymphatic vessels.

Vessel Sealer Curved offers enhanced multifunctionality and precision via its slim, curved jaw designed to follow the natural contours of anatomy, helping improve visibility and control especially in tight spaces and around critical structures. The instrument’s mechanical blade cuts closer to the tip, offering versatility as a dissector.

“We designed Vessel Sealer Curved to give surgeons greater precision in narrow anatomical spaces,” said Iman Jeddi, PhD, senior vice president and general manager, da Vinci platforms & product operations. “By combining the trusted performance of Vessel Sealer Extend with a slimmer, curved jaw profile, we’re helping surgeons work more efficiently and confidently across a wide range of procedures.”

The FDA cleared Vessel Sealer Curved for grasping and blunt dissection of tissue, as well as bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7mm in diameter, lymphatic vessels, and tissue bundles that fit within the instrument’s jaws. Vessel Sealer Curved is not indicated for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

2025 marks Intuitive’s 30th 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 performed nearly 17 million da Vinci procedures, and nearly 90,000 surgeons have been trained to use Intuitive’s systems.

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.

For more information, please visit the company’s website at www.intuitive.com.

Important Safety Information
For product intended use and/or indications for use, risks, cautions, and warnings and full prescribing information, visit https://manuals.intuitivesurgical.com/market. For summary of the risks associated with surgery refer to www.intuitive.com/safety.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4c120cfa-0cfe-4a0e-8eb1-099c537659ca

Contact Information: 

Megan Elliott
megan.elliott@intusurg.com

FAQ

What is the new FDA clearance for Intuitive (ISRG) Vessel Sealer Curved?

The Vessel Sealer Curved received FDA clearance for sealing, cutting, grasping, and dissecting tissue, including blood vessels up to 7mm in diameter and lymphatic vessels. It's designed for use with multiport da Vinci systems.

What are the key features of ISRG's new Vessel Sealer Curved instrument?

The instrument features a unique curved tip, fully wristed design, slim curved jaw profile, and mechanical blade that cuts closer to the tip. It's designed for enhanced precision in narrow anatomical spaces.

What procedures can Intuitive's Vessel Sealer Curved be used for?

It can be used for grasping and blunt dissection of tissue, bipolar coagulation and mechanical transection of blood vessels, lymphatic vessels, and tissue bundles. However, it's not indicated for tubal sterilization procedures.

How many da Vinci procedures has Intuitive (ISRG) performed as of 2025?

As of 2025, surgeons have performed nearly 17 million da Vinci procedures, with approximately 90,000 surgeons trained to use Intuitive's systems over its 30-year history.

What makes the ISRG Vessel Sealer Curved different from previous instruments?

It's the first of Intuitive's advanced energy instruments to receive FDA clearance for lymphatic vessel transection, and features a unique curved jaw design that follows natural anatomical contours for better visibility and control.