Product Approval Summaries

DEVICES

Biotronik has received FDA approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation that adapts the heart rate in response to physiological demands.

FDA has approved a Boston Scientific PMA for two catheters that can be used with its Rhythmia Mapping System — the IntellaNav XP and the IntellaNav MiFi XP navigation-enabled ablation catheters — which are intended to treat Type I atrial flutter. “These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market,” the company says, adding that a software enhancement for its mapping system was also approved. “Unlike conventional cardiac mapping systems, the Rhythmia Mapping System rapidly and automatically generates three-dimensional images of any chamber of the heart to help diagnose, locate and treat the source of rhythm abnormality,” Boston Scientific says.

First Ray has received FDA 510(k) clearance for its Stealth Staple System, an intraosseous small bone fixation device for treating arthrodesis, osteotomies and bone fractures. Current standard-of-care devices are primarily bone plates and bone screws, or bone staples, according to the company. “Since the Stealth Staple is completely contained within the bone upon implantation, clinical complications related to prominent hardware may be substantially reduced,” the company says.

FDA has cleared an Irvine Scientific 510(k) for expanded use of its Vit Kit vitrification media to include human oocytes. The company says it is the first to obtain such a clearance. Its Vit Kit-Freeze and Vit Kit-Thaw are now intended for use with oocytes, pronuclear zygotes through day three cleavage-stage embryos and blastocyst-stage embryos. Vitrification is a cryopreservation technique that Irvine Scientific says provides “excellent survivability of embryos and oocytes through dehydration and ultra-rapid cooling. This process eliminates the concerns of damaging ice-crystal formation associated with traditional slow freezing. The ability to offer an FDA-cleared vitrification media for oocytes will enhance the ability of fertility clinics to preserve women’s fertility through oocyte freezing.”

Medtronic has received FDA 510(k) clearance for its StrataMR valves and shunts, which are used in treating patients with hydrocephalus and cerebrospinal fluid disorders. The clearance covers the device’s acceptable performance during magnetic resonance imaging (MRI) examinations, according to the company. The device contains a magnet inside the valve mechanism that allows neurosurgeons to adjust the performance level in an office setting. “Although neurosurgeons should still check performance levels after MRI exposure, the StrataMR system is designed to resist setting changes in an MRI field of up to 3.0 Tesla,” the company says.

FDA has cleared a Signostics 510(k) for Uscan, which the company describes as the first smart mobile-connected ultrasound visualization device targeted at urologic care. “Using algorithms from the science of computer vision, Uscan actively recognizes the 3D contours of the bladder, for far more accurate volume measurements than the industry standard, even on obese and other hard-to-scan patients,” it says.

HUMAN DRUGS

Acadia Pharmaceuticals has received FDA approval of an NDA for Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. “Hallucinations or delusions can occur in as many as 50% of patients with Parkinson’s disease at some time during the course of their illness,” an agency release says.

Breckenridge Pharmaceutical and MSN Laboratories were granted final approval for their ANDA lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg. a generic version of UCB Pharma’s Vimpat, indicated to treat partial-onset seizures in people 17 years of age and older.

FDA has approved an Eisai NDA for Fycompa (perampanel) oral suspension as adjunctive therapy for treating partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the company’s Fycompa tablet formulation. Approval was based on a bioequivalence study that demonstrated sameness between a single dose of perampanel oral suspension and a single dose of perampanel tablet, when administered under fasted conditions in healthy subjects.

FDA has approved a Tolmar Pharmaceuticals NDA supplement to update the label for Eligard (leuprolide acetate for injectable suspension), indicated for the palliative treatment of advanced prostate cancer. The update covers drug stability data that show, prior to mixing, Eligard may be stored at room temperature (59 – 86° F) for up to eight weeks following removal from refrigeration. The luteinizing hormone-releasing hormone (LHRH) agonist is designed to reduce the amount of testosterone in the body by reducing its production.