Karl Storz Wins FDA Clearance for ENDOFLATOR + Insufflator With Smoke Removal Technology

Karl Storz wins FDA Clearance for its ENDOFLATOR: ©Georgii - stock.adobe.com

Karl Storz announced that it has received U.S. Food and Drug Administration clearance for its ENDOFLATOR +, a next-generation insufflator designed to improve surgical visibility and safety by combining high flowrates with integrated smoke evacuation.

The ENDOFLATOR + uses carbon dioxide to create and maintain a working cavity inside the body during laparoscopic and robotic surgeries, giving surgeons room to operate. The system also incorporates an ultra-low penetration air (ULPA) filter and multiple smoke evacuation modes to remove surgical smoke and particulates, which can otherwise obscure vision and expose surgical teams to harmful byproducts.

Features include carbon dioxide insufflation up to 50 liters per minute, four procedural modes tailored to different specialties, heated and humidified gas delivery, and RFID-enabled tubing sets for safety and simplicity. The device is intended for a wide range of procedures across specialties such as general surgery, gynecology, urology, and cardiovascular surgery.

“This launch marks a major milestone for Karl Storz and the healthcare providers we serve,” said Fernando Morales, vice president of surgical and OR integration at Karl Storz, in a statement. “The ENDOFLATOR + not only meets high standards of safety and performance but also aligns with new surgical smoke evacuation mandates across multiple states.”

The ENDOFLATOR + and its proprietary tubing sets are now available for order in the U.S.

Advances in surgical insufflation and smoke evacuation

The clearance of the ENDOFLATOR + comes as hospitals and surgical centers increasingly prioritize tools that can improve safety and precision in minimally invasive surgery. Insufflation systems—devices that use carbon dioxide to expand and stabilize the surgical cavity—are evolving to deliver higher flowrates, more consistent pressure control, and patient-friendly features such as heated and humidified gas. These advances are designed to reduce patient discomfort, minimize hypothermia during long procedures, and enhance surgeon maneuverability.

At the same time, regulatory and professional attention on surgical smoke evacuation is reshaping operating room practices. Several states now require hospitals to implement smoke evacuation technology, citing health risks from long-term exposure to surgical plumes, which contain chemical and biological contaminants. In response, modern insufflation systems are increasingly integrating smoke removal capabilities directly into their platforms, eliminating the need for separate devices.

The latest systems also feature flexible procedural modes that allow surgeons to optimize insufflation settings for specific surgeries, from delicate pediatric procedures to complex colorectal and cardiovascular operations. Enhanced filtration technology, such as ULPA filters, is being adopted to remove ultrafine particles while maintaining clear imaging.

Robotic surgery is another driver of innovation. As more hospitals adopt robotic platforms, demand is growing for insufflation systems that can support stable operating fields while ensuring clear visualization through smoke removal. These integrated solutions are aimed at improving surgical precision, reducing risks to staff, and helping facilities comply with evolving safety standards.

Together, these advances reflect a shift toward more comprehensive and intelligent insufflation platforms, designed not only to expand the surgical field but also to protect both patients and care teams in increasingly complex operating room environments.