System designed to enhance procedural safety in abdominal cavity during gynecological procedures; Integrated guard provides greater protection around surgical incision1
Olympus announces the launch of the Guardenia Contained Extraction System for manual morcellation.
CENTER VALLEY, Pa. (Sept. 14, 2022) - Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced today the market launch of the Guardenia™ Contained Extraction System. Guardenia is the latest innovation in their contained tissue extraction product portfolio for gynecological procedures and is manufactured by Advanced Surgical Concepts (ASC) Ltd. of Bray, Ireland. Olympus America Inc. is the exclusive U.S. distributor of the system, which is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
The Guardenia system is designed to prevent the escape of cells into the abdominal cavity during extracorporeal manual morcellation, and its integrated guard provides protection against inadvertent damage from sharp surgical instruments around the incision. The guard offers superior incision retraction and protects a greater area of the containment element when compared to currently marketed devices.1
"Olympus is very pleased to continue its successful partnership with Advanced Surgical Concepts to provide innovative gynecological products for women's health care in the U.S.," said Richard Reynolds, President, Medical Systems Group, Olympus Corporation of the Americas. "Advancements in treatments such as contained tissue extraction help keep patients safe and can improve surgical outcomes, both of which are important aims of healthcare, while allowing surgeons to approach procedures with as minimally invasive an approach as possible."
"The Guardenia device offers a new standard of care for the patient through its novel technology," states Frank Bonadio CEO of ASC. "We're pleased to work with Olympus to launch the device."
Guardenia™ maximizes the amount of available space in the incision during a procedure by encroaching less into the incision and maintaining a stable protective area to complete manual tissue morcellation. Once in place, the design of the containment bag and guard ensures more durable protection of the specimen bag and the incision as compared to other marketed devices.1
Protection of the integrity of the specimen bag is one of the critical design features of the Guardenia device. Guardenia's design securely anchors the guard and prevents bag dislodgement.1
Other features of Guardenia include:
- Can be deployed through a standard 12mm trocar, under pneumoperitoneum and with or without vision;1
- Guardenia is universal, and one size fits all;1
- The guard automatically conforms to the shape and size of the incision to provide maximal protection of the containment bag;1
- The guard is securely anchored in the incision and cannot become dislodged during tissue extraction;1
- Employs "Set and forget" technology, allowing the surgeon to focus on the process of morcellation;1
- Superior retraction of the incision, maximizing the working area for more ergonomic morcellation;1
- Maximizes the ratio of incision size to extraction opening;1
- Bag material is designed to be impermeable to the passage of liquid or tissue, measured down to the cellular level;1
- The device works across multiport, robotic and single-port surgery;1
- No additional training is necessary.1
Potential complications associated with the use of the Guardenia device are the same as those associated with the use of tissue or specimen bags, morcellation and laparoscopic surgery in general and include but are not limited to superficial lesions, injury to internal vessels, bleeding, hematoma, injury to the abdominal wall, injury to bowel, infection, peritonitis and spread of benign or malignant tissue.
For more information, visit the Guardenia™ Contained Extraction System product page.
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About Olympus
Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments. For more information, visit https://medical.olympusamerica.com.
About Advanced Surgical Concepts
Advanced Surgical Concepts (ASC) works closely with surgeons and specialist clinicians to conceive of new approaches to performing surgeries. In so doing, ASC designs and develops new medical devices to standardize the methods by which particular surgeries or diagnostic procedures will be performed. For more information, visit ASC at https://advancedsurgical.ie.
- Data on file with ASC and Olympus 9/17/2021