A Medical Device Daily
Boston Scientific (Natick, Massachusetts) last week rolled out news of two international approvals. It reported receiving the CE mark for its new Artisan 2x8 Surgical Lead for the Precision Spinal Cord Stimulation (SCS) System as well as approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its Liberte bare-metal (BMS) coronary stent.
The news comes on the heels of the company also winning FDA approval of NexStent and plans to acquire its manufacturer, EndoTex Interventional Systems (Cupertino, California), within 90 days.
The Artisan 2x8 Surgical Lead features 16 tightly spaced contacts in a two-column array that are connected to the Precision implantable pulse generator which enables each of the 16 Artisan lead contacts to be independently powered and controlled.
“The Artisan lead addresses the needs of those patients who require the stability of a surgical lead to reap the benefits of the precise stimulation technology,” said James Akinwunmi, a consultant neurosurgeon from the Princess Royal Hospital (West Sussex, UK). “The combination of the Artisan lead with the Precision System makes neurostimulation accessible to more patients with chronic pain.”
The Precision SCS System is an implantable neuromodulation device, programmable to fit the patient, providing pain relief by delivering electric signals that mask pain by inducing a tingling sensation called paresthesia. Patients can control their pain using a convenient remote control for device activation.
The Artisan surgical or “paddle” lead potentially expands the application of the company’s technology to another 20% of pain sufferers, said Ed Northup, president of the company’s Pain Management business. He touted neurostimulation as an alternative to the “side effects of pain killers.”
As to the Liberte BMS, the company said it would pursue launch following reimbursement approval.
The Liberte stent has thin struts and a low delivery profile designed to provide enhanced lesion access in challenging anatomy.
Paul LaViollete, chief operating officer, noted the approval as a key step “in the evolution of our drug-eluting stent program in Japan.