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Business Observer Thursday, Aug. 1, 2019 2 months ago

Medical device firm scores major win from FDA

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Arthrex’s  Eclipse Total Shoulder Replacement System has been clinically proven in Europe and Canada with more than 20,000 successful implantations.

NAPLES — Orthopedic surgical device firm Arthrex won a major victory from the FDA Aug. 1, with agency announcing clearance of the company’s Eclipse Total Shoulder Replacement System.

The Eclipse system, the company says in a statement, is a novel, less invasive, bone-preserving total shoulder replacement that has been clinically proven in Europe and Canada with more than 20,000 successful implantations over the past 14 years. The system was the first total shoulder implant to replace traditional long stem fixation with short, fenestrated cage screw fixation for bone ingrowth, eliminating the need for bone cement, the release adds.

“The unique design of the Eclipse implant with compressive cage screw fixation and a critical cortex-engaging trunnion, thereby reducing stress shielding commonly seen in stemless arthroplasty, is bone preserving compared to all other available stemless and traditional stemmed implants,” Arthrex Vice President of Strategic Development Dr. Larry Higgins says in the release. “The Eclipse system allows for patient-specific replacement, independent of humeral anatomy with a wide array of implant sizes for all patients.” 

Arthrex, which handles design, research, manufacturing and medical education of orthopedic surgical devices, develops and releases more than 2,000 new products and procedures every year to advance minimally invasive orthopedics worldwide.

 

 

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