Algovita SCS System Approved
The US Food and Drug Administration has approved Algovita Spinal Cord Stimulation (SCS) System "to treat chronic intractable pain of the trunk and/or limbs," according to a press release from Greatbatch, Inc.
Like Sensa System, which was approved in May 2015, Algovita SCS System is indicated for patients with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain, according to a letter from the FDA.
"We are excited to receive approval from the FDA for the Algovita SCS system," said Thomas J. Hook, president and CEO of Greatbatch, Inc. "Algovita's approval not only supports the proposed [subsidiary Nuvectra], but the system brings to the U.S. market a robust and user-friendly device for patients suffering from chronic pain."
The new company will be focused on the commercialization of the Algovita SCS system, used to treat a variety of neuropathic pain conditions.
According to Nuvectra's Website, Algovita features:
- Implantable pulse generators (IPGs) include 24 independent current sources and two separate header configurations (2x12 and 3x8) for flexibility in configurations
- Broad spectrum of outputs and parametric ranges
- Small, thin volume
- Rechargeable, deep-discharge recovery battery
- Wireless programming in the operating room and clinic
Algovita also offers stretchable SCS leads, noted Nuvectra. They are available in a variety of configurations and lengths to provide up to 3 vertebral lengths of coverage and flexibility for individual patient needs.
- Stretchable, kink-resistant, coil-in-coil body
- Percutaneous leads: 12 and 8 electrode arrays with multiple spacing and length options
- Paddle leads: two configurations with reduced volume and optional stylet steering
The system provides clinicians with an algorithm-driven "stimulation programming to assist with effective and efficient localization, targeting and fine-tuning of pain coverage," according to the company.
For more information, visit Nuvecta's Web site