ADDING MULTIMEDIA KARL STORZ Announces FDA Clearance for ENDOFLATOR + Insufflator and Smoke Evacuation System

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EL SEGUNDO, Calif.--(BUSINESS WIRE)--Oct 3, 2025--

KARL STORZ, a global leader in minimally invasive surgical technology, is proud to announce it has received U.S. Food and Drug Administration (FDA) clearance for the ENDOFLATOR™ +.

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The KARL STORZ Endoflator + offers insufflation with an integrated surgical smoke evacuation system.

ENDOFLATOR + is the next-generation insufflator with integrated surgical smoke evacuation system designed to meet the evolving needs of modern operating rooms.

Using carbon dioxide gas, an insufflator establishes and maintains a stable working cavity within the body during laparoscopic and robotic procedures, providing surgeons with the necessary space to operate. When paired with smoke evacuation, the insufflator is designed to preserve image clarity by removing surgical smoke and particulates, improving visibility and allowing for enhanced surgical precision.

The ENDOFLATOR + represents a significant leap forward, offering high flowrates and an ULPA filter that helps maintain a smoke-free image, improving visibility and maneuverability while reducing harmful surgical smoke. Specific features include:

• CO₂ insufflation up to 50 L/min
• Integrated smoke evacuation in HF and continuous modes
• Four procedural modes: high-flow, pediatric, taTME, and EVH
• Heated and humidified gas delivery with proprietary tubing sets
• RFID-enabled tubing for simplicity and safety

The system is engineered to support procedures across various specialties—general surgery, cardiovascular surgery, colorectal surgery, gynecology, pediatric surgery*, proctology, and urology—in both conventional laparoscopic and robotic settings.

“This launch marks a major milestone for KARL STORZ and the healthcare providers we serve,” said Fernando Morales, Vice President, Surgical & OR Integration. “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 five proprietary tubing sets are now available for order. Customers are encouraged to contact their KARL STORZ representative for demos, pricing, and promotional offers.

*cleared for patients aged 2 and up

About KARL STORZ

KARL STORZ is an innovative leader in endoscopic technology and surgical imaging solutions across virtually all surgical specialties. Its integrated OR solutions, including advancements in digital surgery, enhance collaboration to improve clinical efficiency and outcomes inside the hospital and across other sites of care. With subsidiaries around the world, KARL STORZ is a family-owned company based in Germany that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness. For more information, visit www.karlstorz.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20251001587199/en/

CONTACT: Media contact:

Susan Mancia

Marketing Communications

KARL STORZ United States

657-385-5285

KEYWORD: GERMANY EUROPE UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: FDA HEALTH SURGERY MEDICAL DEVICES

SOURCE: KARL STORZ

Copyright Business Wire 2025.

PUB: 10/03/2025 02:06 PM/DISC: 10/03/2025 02:05 PM

http://www.businesswire.com/news/home/20251001587199/en