MINNETONKA, Minn.–(BUSINESS WIRE)–Anulex Technologies, Inc., a privately held medical device manufacturer, has announced the U.S. Food and Drug Administration (FDA) has informed the Company that the actions undertaken to address issues cited in a warning letter from February 2011 have been deemed adequate
“We are encouraged that the FDA has taken a positive view of our corrective actions”
Anulex received an FDA warning letter regarding certain aspects of its post-market study and promotional activities for its legally marketable Xclose™ Tissue Repair System.
“We are encouraged that the FDA has taken a positive view of our corrective actions,” said Jeff Peters, Anulex’s Chief Executive Officer. “Patient safety has always been, and continues to be, our foremost priority. The postmarket study as well as considerable usage outside the study has not resulted in the reported occurrence of any patient safety issues or adverse events beyond those anticipated for procedures involving suturing in general and other orthopedic surgeries. We continue to be committed to conducting every aspect of our business in compliance with applicable regulatory requirements.”
The Xclose™ Tissue Repair System was cleared in 2006 and continues to be available to facilitate surgeons in providing a unique method of approximating soft tissue for procedures such as general and orthopedic surgery.
About Anulex Technologies, Inc.
Anulex Technologies, Inc. is dedicated to the development and commercialization of unique and proprietary soft tissue repair and fixation products. For more information, please visit:www.anulex.com
Contacts
Rotenberg Associates LLC
Amy Rotenberg Esq., 612-336-7705
arotenberg@rotenbergassoc.com
