Editor: What To Know
- CoNextions Medical notes that a 17-year-old male patient with a severed extensor tendon of his thumb due to traumatic injury became the first outside of a clinical trial to undergo tendon repair with CoNextions Medical’s TR Tendon Repair device since the product’s recent approval in Chile, the first country to approve the device.
- Our development program in the US is accelerating, as we anticipate completing a clinical trial to support a 510(k) submission [in the coming months] to the FDA for commercial approval in the United States.
- CoNextions TR allows surgeons to produce a rapid, strong, low profile, and reproducible repair in any lacerated or ruptured tendon appropriately sized for the device in the hand, wrist, forearm, foot, and ankle.
CoNextions Medical notes that a 17-year-old male patient with a severed extensor tendon of his thumb due to traumatic injury became the first outside of a clinical trial to undergo tendon repair with CoNextions Medical’s TR Tendon Repair device since the product’s recent approval in Chile, the first country to approve the device.
“[The CoNextions TR] device is an excellent alternative [to suture],” said Hernan Vielma, MD at Clinica Bupa Santiago, Chile.
Dan Gruppo, CoNextions Medical’s Executive Vice President of Global Sales and Marketing said: “This is an important step forward in our mission to improve the outcomes of tendon repairs globally. With the support of our distributor in Chile, CLP Insumos Medicos, we are working to ensure patients there have access to this advanced medical technology. Our development program in the US is accelerating, as we anticipate completing a clinical trial to support a 510(k) submission [in the coming months] to the FDA for commercial approval in the United States.”
The CoNextions TR is a stainless steel and ultra-high molecular weight polyethylene implant developed as an alternative to traditional suturing. CoNextions TR allows surgeons to produce a rapid, strong, low profile, and reproducible repair in any lacerated or ruptured tendon appropriately sized for the device in the hand, wrist, forearm, foot, and ankle.
