04.01.15
Amsterdam, Netherlands-based Tornier N.V., a medical device company focused on orthopedic extremity surgical solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simpliciti shoulder system. The bone sparing total shoulder arthroplasty system is designed to treat patients experiencing severe shoulder joint pain, compromised range of motion, loss of strength and functionality, and is intended to preserve both the patient’s native bone and avoid further trauma to the surrounding soft tissue.
R. Sean Churchill, M.D., lead investigator in the investigational device exemption (IDE) study, said: “In my practice, a new category of younger, more active patients has emerged. These patients are more demanding and aren’t satisfied with modifying their lifestyle as a result of shoulder pain. The humeral canal sparing design and revision optionality of the Simpliciti Shoulder System allows me to address this patient population that I have been hesitant to treat with traditional implant systems. Another benefit of the ultra short-stem design is the absence of a metal implant extending into the distal humeral canal, thereby reducing the risk of a mid-shaft humerus fracture, which can serve to compromise typical total shoulder implants.”
Designed in partnership with shoulder surgeons to address the challenges associated with implantation of conventional, long stemmed prostheses, Simpliciti provides upper extremity surgeons with a humeral component intended to deliver the freedoms of precise anatomic placement without the constraints of fixed inclinations, medial offset or posterior offset. Simpliciti is intended to deliver anatomic results without the procedural complexity of traditional stemmed components. The system provides surgeons with an earlier intervention option for treatment of younger patients with shoulder osteoarthritis by minimizing bone removal and soft tissue disruption.
“Simpliciti delivers anatomic results without the procedural complexity of traditional stemmed components,” said T. Bradley Edwards, M.D. “The specific features of the system enable physicians to minimize bone disruption thereby reducing procedure times, minimizing blood loss and exposure to anesthesia. These benefits appeal not only to the surgeon, but to the hospital administrators looking to improve patient satisfaction while managing procedure costs.”
“We are pleased with the results of the Simpliciti clinical study which supported the FDA’s clearance of this product,” said Dave Mowry, president and CEO of Tornier. “ Studies such as the Simpliciti IDE trial serve as a testament to Tornier’s ongoing commitment to responsible science and technological evolution that provides extremity surgeons and their patients with solutions to address the debilitating results of osteoarthritis. Similar to our… Aequalis Ascend Flex shoulder system, we plan to introduce the Simpliciti product through a measured process to ensure education and training paces our product deployment. We believe building long-term success in this new category will take an investment in training and education while allowing the market time to develop.”
The Simpliciti clearance is the result of a comprehensive IDE study conducted with U.S. surgeons from 2011 through 2014, including a two-year follow-up to ensure its efficacy.
R. Sean Churchill, M.D., lead investigator in the investigational device exemption (IDE) study, said: “In my practice, a new category of younger, more active patients has emerged. These patients are more demanding and aren’t satisfied with modifying their lifestyle as a result of shoulder pain. The humeral canal sparing design and revision optionality of the Simpliciti Shoulder System allows me to address this patient population that I have been hesitant to treat with traditional implant systems. Another benefit of the ultra short-stem design is the absence of a metal implant extending into the distal humeral canal, thereby reducing the risk of a mid-shaft humerus fracture, which can serve to compromise typical total shoulder implants.”
Designed in partnership with shoulder surgeons to address the challenges associated with implantation of conventional, long stemmed prostheses, Simpliciti provides upper extremity surgeons with a humeral component intended to deliver the freedoms of precise anatomic placement without the constraints of fixed inclinations, medial offset or posterior offset. Simpliciti is intended to deliver anatomic results without the procedural complexity of traditional stemmed components. The system provides surgeons with an earlier intervention option for treatment of younger patients with shoulder osteoarthritis by minimizing bone removal and soft tissue disruption.
“Simpliciti delivers anatomic results without the procedural complexity of traditional stemmed components,” said T. Bradley Edwards, M.D. “The specific features of the system enable physicians to minimize bone disruption thereby reducing procedure times, minimizing blood loss and exposure to anesthesia. These benefits appeal not only to the surgeon, but to the hospital administrators looking to improve patient satisfaction while managing procedure costs.”
“We are pleased with the results of the Simpliciti clinical study which supported the FDA’s clearance of this product,” said Dave Mowry, president and CEO of Tornier. “ Studies such as the Simpliciti IDE trial serve as a testament to Tornier’s ongoing commitment to responsible science and technological evolution that provides extremity surgeons and their patients with solutions to address the debilitating results of osteoarthritis. Similar to our… Aequalis Ascend Flex shoulder system, we plan to introduce the Simpliciti product through a measured process to ensure education and training paces our product deployment. We believe building long-term success in this new category will take an investment in training and education while allowing the market time to develop.”
The Simpliciti clearance is the result of a comprehensive IDE study conducted with U.S. surgeons from 2011 through 2014, including a two-year follow-up to ensure its efficacy.