Contained Tissue Extraction System

Tissue Management System

Contained Tissue Extraction System

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Contained Tissue Extraction System

The Olympus Contained Tissue Extraction (CTE) System combines the PneumoLiner, a first-of-its-kind tissue containment device, and the next-generation laparoscopic PK Morcellator to provide certain appropriate, low-risk patients with a laparoscopic surgery option to avoid open hysterectomy and myomectomy.

PneumoLiner
Containment Device

PneumoLiner is the first and only power morcellation containment device specifically designed for intra-abdominal insufflation during GYN procedures.

The PneumoLiner is uniquely designed to:

  • Conform to each patient's abdominal size, avoiding intra-abdominal folding of material which can restrict movement, visualization, or inadvertent capture by the morcellator.
  • Provide a barrier between target tissue and non-targeted abdominal contents.
  • Maintain a barrier to the escape of fluids, cells and tissue fragments.

FDA Clearance & Letters:

WARNING: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.

CONTRAINDICATIONS: Do not use on tissue that is known or suspected to contain malignancy. Do not use for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision. Do not use in women with undiagnosed uterine bleeding. Do not use this device on patients with known or suspected allergies to polyurethane. Do not use where the abdominal wall thickness is larger than 10cm. This device should only be used by physicians who have completed the formal validated training program administered by Olympus and/or Advanced Surgical Concepts.

For more information, please read the full PneumoLiner Instructions for Use for indications, additional contraindications, warnings and precautions.

For additional information, please view the videos below from AAGL 2015.


PK Morcellator

The device is intended for cutting and extracting tissue in laparoscopic gynecologic procedures. The PK Morcellator is recommended in conjunction with the PneumoLiner containment device for removal of uterine tissue.

The PK Morcellator design features:

  • Anti-Coring Tip - Integrated peeling tip promotes peeling on target tissue and avoids tissue coring throughout the procedure.
  • Reduced Surgical Smoke - The smoke management of the PK Morcellator maintains clear visibility of the morcellator, the target tissue and collateral tissue compared to PKS PlasmaSORD.
  • Faster Morcellation Speed - PK Morcellator completes morcellation at a faster rate than PKS PlasmaSORD.

FDA Clearance & Letters:

WARNING: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

CONTRAINDICATIONS: The use of the PK Morcellator is contraindicated for surgical procedures in which the tissue to be morcellated is known or suspected to contain malignancy. The PK Morcellator is contraindicated for removal of uterine tissue containing suspected fibroids in the following patient groups:

  • Peri- or post-menopausal patients.
  • Candidates for en bloc tissue removal. For example, through the vagina or via a mini-laparotomy incision.

The use of the electrosurgical generator ESG 400 is contraindicated when, in the judgment of the physician, bipolar electrosurgical procedures with the PK Morcellator would be contrary to the best interests of the patient or user. For patients with active electronic devices implanted, refer to the instructions for use for those devices before using bipolar electrosurgery.

The PK Morcellator should not be used if the patient is not considered suitable for a laparoscopic hysterectomy procedure or a laparoscopic myomectomy procedure.

For additional information, please view the videos below from AAGL 2015.


Videos

PATIENT

At Olympus, we know it’s important that you feel at ease discussing health issues with your physician. Whether you are preparing for an initial visit or seeking more information when considering treatment options, we offer resources that will provide insight and help you in making an informed decision.

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Different WOmen. Different Needs. Your guide to minimally invasive hysterectomy.

Events

  • Society of Laparoendoscopic Surgeons (SLS) 2018

    August 29th – September 1st
    New York, NY
  • American College of Obstetricians (ACOG) Armed Forces District Meeting 2018

    September 23rd – 26th
    Honolulu, HI
  • American Society for Reproductive Medicine (ASRM) 2018

    October 6th – 10th
    Denver, CO
  • American Urogynecologic Society (AUGS) 2018

    October 9th – 13th
    Chicago, IL
  • American Association of Gynecologic Laparoscopists (AAGL) 2018

    November 11th – 15th
    Las Vegas, NV
  • Pelvic Anatomy & Gynecologic Surgery Symposium (PAGS) 2018

    December 6th – 8th
    Las Vegas, NV
  • Society of Gynecologic Oncology (SGO) 2019

    March 16th – 19th
    Honolulu, HI
  • Society of Gynecologic Surgeons (SGS) 2019

    March 31st – April 3rd
    Tucson, AZ
  • The Association of periOperative Registered Nurses (AORN) 2019

    April 6th – 10th
    Nashville, TN
  • American College of Obstetricians (ACOG) 2019

    May 3rd – 6th
    Nashville, TN

Additional Reading