FDA approves new device to treat epilepsy
The FDA approved a new device to help reduce the frequency of seizures in patients with epilepsy who have not responded well to medications. The RNS Stimulator, a product of Neuropace, Inc. (Mountain View, CA) is a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two electrodes placed where the seizures are suspected to originate within the brain or on the surface of the brain.
The neurostimulator detects abnormal electrical activity in the brain and responds by delivering electrical stimulation intended to normalize brain activity before the patient experiences seizure symptoms.
The approval is supported by a 3-month randomized controlled trial of 191 patients with drug-resistant epilepsy. The study found that by 3 months after implantation and active use, patients experienced a nearly 38% reduction in the average number of seizures per month, compared with an approximately 17% reduction in the average number of seizures per month in patients who had the implanted devices turned off. At the end of 3 months, the median reduction in seizures was 34% with active use and about 19% with the device turned off. During the trial, 29% of patients with an active device experienced at least a 50% reduction in the overall number of seizures compared with 27% for those with the implanted device turned off.
The most frequent adverse events reported in the trials were implant site infection and premature battery depletion.
New everolimus-eluting stent approved
Boston Scientific's (Natick, MA) Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System has received FDA approval. The new stent is the company's next-generation durable polymer drug-eluting stent (DES).
The new stent offers improved DES performance in treating patients with coronary artery disease and features unique, customized, platinum chromium alloy stent architecture, everolimus with a biocompatible, fluorinated copolymer, and an enhanced stent delivery system. It was developed with extensive input from interventional cardiologists and features unparalleled visibility, low recoil, exceptional radial strength, and fracture resistance while improving axial strength and deliverability.
The everolimus drug and PVDF-HFP stent coating have been studied in multiple randomized clinical trials, demonstrating long-term safety and efficacy.
The Promus Premier Stent System is offered in a matrix of 94 sizes, ranging in diameter from 2.25 to 4.00 mm and lengths of 8 to 38 mm on both Monorail and Over-the-Wire catheter platforms.
Assay detects nucleic acids for C. difficile test
IntelligentMDx (Waltham, MA) received FDA approval for its IMDx C. difficile test for the Abbott m2000 Assay, which detects nucleic acids encoding the toxin A gene and toxin B gene sequences of toxigenic strains of C. difficile-associated disease.
Analytical reactivity studies demonstrated that the IMDx C. difficile for Abbott's m2000 assay is capable of detecting the 31 different toxigenic strains that were tested.
FDA approves Direxion Torqueable Microcatheter
Boston Scientific Corp. (Natick, MA) has received FDA approval for its Direxion Torqueable Microcatheter. It is designed to facilitate selective access and delivery of diagnostic, embolic, and therapeutic materials into the peripheral vasculature.
Offered in either a 0.021- or 0.027-in. inner diameter microcatheter, the Direxion features a slotted, nitinol hypotube technology. This is designed to maximize torque transmission in the catheter shaft, giving the Direxion Torqueable Microcatheter best-in-class handling needed to reach the most challenging anatomy.
The Direxion Torqueable Microcatheter is available in 6-tip configurations as well as preloaded configurations designed to suit a range of peripheral embolization procedures.