Musculoskeletal News Roundup 15-Sept-11
BY LAUREN UZDIENSKI, SEPTEMBER 15, 2011
M&A
Integra announced plans to acquire Ascension Orthopedics for $65.0 million in cash, and in doing so, complement their lower extremity portfolio with new upper extremity and shoulder devices. Ascension represents Integra's first entry into the shoulder market. The company recorded approximately $19.0 million in revenues over the past 12 months.
Regulatory
Internal Fixation Systems received 510(k) clearance to market its bone fixation devices that include various plates, screws and washers used to treat bone fractures and osteotomies. Specifically, the clearance covers a line of locking plates that includes mini-fragment, small fragment and large fragment systems. The first system in the portfolio, a modular locking small fragment set, should be available for sale in 4Q:11.
X-BOLT Orthopaedics received CE mark certification for their expandable X-BOLT device for treating hip fractures. The company also plans to conduct studies on the X-BOLT device at hospitals in Limerick and Waterford, Ireland.
Zimmer's 510(k) clearance for the Universal Clamp Spinal Fixation System was expanded to include pediatric indications. The company says that the system is used in spinal fusion surgeries and now indicated for treatment of idiopathic and neuromuscular scoliosis in patients eight years of age or older.
Product Introduction & Update
Core Essence Orthopaedics launched the PONTiS Knotless Endotendonous system, intended for use during flexor tendon repair procedures.
DePuy Spine launched the VIPER 3D MIS Correction Set. The company says this represents the "first surgical instrumentation system designed specifically for the minimally invasive three-dimensional correction of complex spinal deformities."
DJO launched the Empi Active Knee Transcutaneous Electrical Nerve Stimulation (TENS) System to treat knee pain. TENS systems use electrical stimulation to block the sensation of pain.
Clinical
Baxano enrolled the first patient into its post-market STRiDE (Spondylolisthesis Treated with an iO-Flex System enabled Decompression) study. The iO-Flex system is used in a minimally invasive procedure and consists of flexible instruments "designed to precisely target central, lateral recess and foraminal lumbar stenosis without disrupting spinal anatomy critical for maintaining spinal stability." The study will enroll 150 patients in up to 30 U.S. centers.
Appointments
Boston Scientific appointed Michael Mahoney of Johnson & Johnson its next chief executive officer, succeeding Ray Elliott. Mr. Mahoney will join Boston Scientific October 17 as president and will assume the role of CEO in November 2012. He previously served as the president of the medical devices and diagnostics division at JNJ and has also led DePuy. At Boston Scientific, Mr. Mahoney will be responsible for reinvigorating sales of the company's cardio products.
