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Arthrex Announces FDA Clearance of the Eclipse Total Shoulder Replacement System


Arthrex Announces FDA Clearance of the Eclipse Total Shoulder Replacement System

Arthrex 

FOR IMMEDIATE RELEASE

 

Contact: Lisa Gardiner, Sr. Communications Manager

                  239-643-5553

                  Lisa.Gardiner@Arthrex.com

 

Arthrex Announces FDA Clearance of the Eclipse Total Shoulder Replacement System

NAPLES, FL – August 1, 2019 – Arthrex announces FDA clearance of its Eclipse Total Shoulder Replacement System. The Eclipse system 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 Eclipse 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. Its success as a total shoulder replacement has been demonstrated by outstanding long-term clinical results for the treatment of shoulder arthritis.

“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,” said Arthrex Vice President of Strategic Development Larry Higgins, MD. “The Eclipse system allows for patient-specific replacement, independent of humeral anatomy with a wide array of implant sizes for all patients.” 

With streamlined instrumentation and a simple surgical technique, the Eclipse Total Shoulder Replacement System decreases operating room time yielding a lower infection rate, reduces bone removal, and improves shoulder function, enabling an easier, less invasive, bone-preserving revision compared to traditional stemmed total shoulder arthroplasty.1,2,3

The Eclipse surgical technique is complemented by preoperative planning and patient-specific anatomic device placement using the Arthrex Virtual Implant Positioning (VIP) System, an innovative CT imaging-based program utilizing personalized patient surgical guides allowing for a more accurate and reproducible technique in the operating room, which may result in improved postoperative patient outcomes.4

Watch a patient experience video here or search Eclipse at Arthrex.com for additional information.

About Arthrex

Arthrex Inc., headquartered in Naples, FL, is a global leader in orthopedic surgical device design, research, manufacturing and medical education. Arthrex develops and releases more than 2,000 new products and procedures every year to advance minimally invasive orthopedics worldwide. For more information, visit www.Arthrex.com and www.OrthoIllustrated.com.

 

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1. A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex’s EclipseTM Shoulder to the UniversTM II Shoulder Prosthesis in Patients with a Degenerative Joint Disease (Eclipse™ Shoulder Prosthesis/G110128)

2. BMC Musculoskeletal Disorders (2018), Heuberer et al, 19:28.

3. Journal of Shoulder and Elbow Surgery (2017), Yian et al, Vol 26, Issue 5, 160.

4. Surgical Outcomes System (2019), Clinical Outcomes Report, Anatomic Total Shoulder Arthroplasty (TSA) Virtual Implant Positioning™ (VIP) Preoperative Planning System vs TSA With Arthrex Implants Without Planning

 

Category: Press Releases