PNEUMOLINER FDA-REQUIRED SURGEON TRAINING:

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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

Required Surgeon Training

Successful completion of FDA-required training is required prior to usage of the Pneumoliner. Olympus is hosting nationwide FDA-required training courses to ensure safe and effective use of the product. Below is a list of scheduled events. The training course is 1.5 hours in duration.

December 5 December 5 MarquetteREGISTER
December 7 Bend, ORREGISTER
December 8 The Dalles, ORREGISTER
December 12 Green Bay, WIREGISTER
December 14 & 15, 2017 PAGS Las VegasREGISTER

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Events

  • Society of Laparoendoscopic Surgeons (SLS)

    September 6-9, 2017
    San Francisco, CA
  • American College of Obstetricians (ACOG) Armed Forces District Meeting

    September 24-27, 2017
    San Antonio, Texas
  • American Association of Gynecologic Laparoscopists (AAGL)

    November 12-16, 2017
    Washington, D.C.
  • Pelvic Anatomy & Gynecologic Surgery Symposium (PAGS)

    December 14-16, 2017
    Las Vegas Nevada
  • Society of Gynecologic Surgeons (SGS)

    March 11-14, 2018
    Orlando Florida
  • Society of Gynecologic Oncology (SGO)

    March 24-27, 2018
    New Orleans, Louisiana
  • The Association of periOperative Registered Nurses (AORN)

    March 24-28, 2018
    New Orleans, Louisiana
  • American College of Obstetricians (ACOG)

    April 27-30, 2018
    Austin, Texas