Catalyst OrthoScience received 510(k) in March 2021, conducting limited user release through Q2 2021
Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, today announced the first surgeries using the new Archer™ R1 Reverse Shoulder System. In March, the company received FDA 510(k) clearance and has kicked off a limited user release in Q2 2021.
A commercial launch is planned for later in 2021. With the introduction of the Archer R1 system, Catalyst is addressing the two fastest growing segments of the shoulder arthroplasty market – stemless anatomic and reverse TSA.
“Reverse shoulder arthroplasty encompasses more than 60 percent of the shoulder arthroplasty market,” said Brian K. Hutchison, chairman and CEO of Catalyst. “These first surgeries with our Archer R1 reverse system went well, and we’re excited by the feedback we’re getting from the initial surgeon users.”
“We designed for the first time a single-tray reverse shoulder arthroplasty system which harnesses the best features of existing systems while maximizing ease-of-use, efficiency and bone preservation, among other features,” said John G. Costouros, MD, chief of shoulder surgery at the Institute for Joint Restoration and Research, past professor Stanford University. “My early experience has been exceptional.”
“These are very exciting times, working with the new Archer R1 system,” said Zachary Leitze, MD, orthopedic surgeon at Intermountain Medical Group, St. George, Utah. “The system allowed for an efficient workflow through my surgeries. The humeral components perfectly centered in the metaphyseal cut, the glenoid prep was uncomplicated and the base plate secured well.”
“I am impressed with the workflow,” said Steven Goldberg, MD, orthopedic surgeon at Physicians Regional Medical Center, Naples, Fla. “The real bonus is not from what the system has, but what’s gone – the careful elimination of redundant steps or rarely used tools to make this incredibly efficient for the O.R. team.”
Catalyst’s Archer R1 reverse system is a single-tray arthroplasty system that was engineered to combine the most beneficial and evidence-based attributes of reverse shoulder arthroplasty design. The system offers surgeon-targeted implant positioning, a streamlined and versatile system, and bone sparing implants.
The system is a total shoulder prosthesis designed for patients experiencing severe shoulder arthritis in conjunction with a grossly deficient or non-functional rotator cuff. In a reverse shoulder system, the design is inverted compared to a traditional anatomic total shoulder prosthesis where the articulating sphere is on the glenoid side of the joint and the mating insert is fixed into the humeral stem implant.
Catalyst is one of the fastest-growing players in the anatomic stemless total shoulder arthroplasty market, starting with its popular Archer™ CSR Total Shoulder System. The Archer CSR system combines innovative components and unique instrumentation to bring about a precise, accurate restoration of the shoulder. It features a stemless, ellipsoid humeral component that is engineered to accurately replace the elliptical shape of the patient’s native non-spherical humeral head.
Source: Company Press Release