Olympus wins FDA nod & launches new power morcellator with tissue capture

Olympus (TYO:7733) said today it won FDA 510(k) clearance for its next-gen laparoscopic PK morcellator with tissue containment designed as a laparoscopic surgery option to avoid open hysterectomy and myomectomy for uterine fibroid removal

The company’s newly launched morcellator includes the company’s PneumoLiner contained tissue extraction system.

“Contained tissue extraction is continually evolving. As surgeons, it is our duty to evaluate potential solutions to the surgical challenges we face in clinical practice. We are pleased that Olympus has taken the initiative to develop a unique and well tested system designed specifically to facilitate the option for a laparoscopic approach in women who are at a low risk of having an unexpected malignancy at the time of surgery,” Dr. Arnold Advincula of Sloane Women’s Hospital said in a press release.

The company specified that the device should not be used for the removal of uterine tissue containing suspected fibroids in patients who are peri-menopausal or post-menopausal, or candidates for en bloc tissue removalvaginally or via mini laparotomy.

The device is also not indicated for use with in women with tissue that is known or suspected to contain malignancy.

Power morcellators have been a source of controversy in the past year. In March, Johnson & Johnson (NYSE:JNJ) said it was looking to settle 100s of product liability and wrongful death lawsuits brought over its now-recalled laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors.

Power morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids.

The FDA in April 2014 issued a warning about the devices, later convening a special advisory panel to evaluate their continued use in the surgical suite. The watchdog agency estimates that about 0.3% of women undergoing hysterectomy or fibroid surgery are found to have undetected uterine sarcomas, including the deadly leiomyosarcoma. In November of that year, the FDA ordered so-called “black box” warnings for the labels on morcellators, advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.

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