dimecres, 8 de febrer del 2017

Zimmer Biomet wins CE Mark for Subchondroplasty bone marrow lesion procedure

Zimmer BiometZimmer Biomet (NYSE:ZBH) said today it won CE Mark approval in the European Union for its for the Subchondroplasty procedure designed to treat subchondral bone marrow lesions.

The Warsaw, Ind.-based company’s minimally invasive procedure is designed to repair chronic BMLs includes filling them with AccuFill bone substitute material which is slowly resorbed and replaced with healthy bone.

The procedure is generally performed with arthroscopy for visualization and joint treatments, the company said, with an open or mini-open procedure necessary for certain cases.

“The Subchondroplasty procedure addresses a previously unmet need in my practice for patients with chronic and painful bone marrow lesions. These patients no longer benefit from conservative treatment, yet are not ready for total joint replacement surgery,” Dr. Christopher Baker of Tampa, Fla.’s Florida Orthopedic Institute said in prepared remarks.

Zimmer Biomet said the procedure is currently approved in Canada, Singapore, Malaysia and Hong Kong.

“The international release of the Subchondroplasty Procedure is a major milestone for our company and for patients with chronic bone marrow lesions. The procedure offers a tool that fills a gap in the patient treatment algorithm for the surgeon. We are eager to begin our international commercial launch,” Zimmer Biomet group president David Nolan said in a press release.

Late last month, Zimmer Biomet topped the consensus forecasts for both its 4th-quarter and full-year 2016 results, despite a nearly -50% profit slide for the quarter.

The orthopedics giant posted profits of $66.6 million, or 33¢ per share, on sales of $2.01 billion for the 3 months ended Dec. 31, for a bottom-line decline of -47.6% on sales growth of 4.1% compared with Q4 2015.

Adjusted to exclude 1-time items, earnings per share were 2.14, 3¢ ahead of the consensus on Wall Street, where analysts were looking for sales of $1.98 billion.

The post Zimmer Biomet wins CE Mark for Subchondroplasty bone marrow lesion procedure appeared first on MassDevice.



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