|Truclear hysteroscopic morcellator--Courtesy of Smith & Nephew|
Medtronic ($MDT) is buying up the gynecology business from Smith & Nephew ($SNN) for about $350 million. The move is particularly interesting since the purchase is focused on the Truclear power morcellation system.
This is one of only a few marketed power morcellation systems; the technology has long been under regulatory and governmental scrutiny, but as a hysteroscopic morcellator Truclear is not covered by the 2014 black-box warning from the FDA. The Truclear system is intrauterine and is marketed specifically to remove fibroids and polyps within the uterus.
The FDA issued a warning to Smith & Nephew specifically regarding its manufacturing operations for Truclear in May 2015. At that time, the company put a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigated customer complaints of loss of visualization during usage.
Medtronic is optimistic about the future prospects for Truclear, which is marketed in the U.S. and parts of Europe.
"We believe gynecology is one of the most underserved specialty procedure areas. Smith & Nephew has developed a rapidly growing business that expands minimally invasive treatment options for gynecology patients," said Medtronic SVP and President of Surgical Innovations Chris Barry in a statement. "This acquisition expands our existing gynecology portfolio and we believe creates opportunities to further explore and develop global therapies and solutions that improve gynecological surgery."
The company noted that more than 100 million women globally suffer from abnormal uterine bleeding with less than 15% receiving treatment annually. It expects Truclear could be more broadly used to address this problem.
The deal is expected to close this summer. The gynecology business will become part of Medtronic's Surgical Solutions division within the Minimally Invasive Technologies Group. The Minimally Invasive Group comprises about one-third of Medtronic by sales. It grew 5% last quarter to reach $2.3 billion with Surgical Solutions growing 7% to $1.3 billion.
- here is the announcement
Editor's note: An earlier version of this article did not identify Truclear as a hysteroscopic morcellator, which is exempt from the FDA's black box warning on power morcellators.