A Medical Device Daily

Vidacare (San Antonio), a developer of advanced intraosseous technology, said it has received FDA clearance to market its new bone marrow biopsy (trephine) system. With its lithium-powered driver, the OnControl bone marrow biopsy system represents what the company called “the first effort in decades to improve the speed, control, core capture rate and patient comfort of the bone marrow biopsy procedure. “

“The FDA’s approval of the OnControl Biopsy System is a key milestone for Vidacare as well as patients requiring bone marrow biopsies,” said President/CEO Philip Faris Jr. “Bone marrow biopsies are the most frequently performed intraosseous diagnostic procedure in the U.S. and around the world. Virtually unchanged for decades, the manual procedure causes pain rated as severe to worst possible pain by nearly 20% of patients participating in a recent study.”

He added: “The goal of the OnControl biopsy system is to provide greater clinician control while increasing the core capture rate, and decreasing the discomfort experienced by patients and clinicians.”

The system uses a lithium-powered driver, connected to 11-gauge, 102 mm or 152 mm needles with specialized bi-beveled cutting tips and includes a biopsy tray designed to simplify needle set access and usage while maintaining a sterile environment. The cannula features a standard luer-lock connector.

Vidacare has created a training package designed to provide a realistic sensation of needle placement.