Product Approval Summaries
DEVICES
FDA has cleared an ACell, Inc. 510(k) for its MicroMatrix device and its concurrent use with Cytal Wound Matrix or Cytal Burn Matrix devices. The micronized particulate form of ACell’s patented Urinary Bladder Matrix technology provides coverage of the wound bed, especially in irregular wounds. It provides a “robust scaffold for cell infiltration and host tissue deposition,” according to the company.
Great Basin Scientific has received FDA 510(k) clearance for its Shiga Toxin Direct Test, a stand-alone molecular diagnostic for detecting Shiga toxin-producing E. coli (STEC) and the serotype O157 directly from a patient specimen. The test can be run on the Great Basin Analyzer, which also performs low-plex tests for Clostridium difficile and Group B Streptococcus.
FDA has approved an Intersect ENT PMA supplement a for an expanded indication for its Propel mini steroid releasing sinus implant to treat patients undergoing frontal sinus surgery. The approval allows the company to market the device for implanting in the frontal sinuses, located behind the eyebrows. Previously, it was indicated for placement in the ethmoid sinuses, located just behind the bridge of the nose.
Olea Medical has received FDA 510(k) clearance for its Olea Sphere 3.0 medical imaging software package, which is intended for picture archiving, post-processing and communication. The software is designed to help standardize both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with magnetic resonance imaging and computed tomography. “It features innovative image viewing, analysis and processing of most complex MR sequences as well as longitudinal analysis of multiple time points,” the company says.
FDA has cleared an Opsens 510(k) for the OptoWire II, an optical guidewire developed to measure fractional flow reserve to diagnose severity of coronary stenosis for guiding the treatment of patients with coronary artery disease. The next-generation device features a new design comprising a hydrophilic coating that the company says is intended to further improve the guidewire performance in different scenarios, such as in highly calcified and tortuous vessels. The device provides intra-coronary blood pressure measurements using patented optical pressure guidewire technologies, according to Opsens. “It is immune to adverse effects related to blood contact, and allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of usage,” it says.
FDA has approved Roche’s hepatitis C virus (HCV) quantitative RNA test to be used as an aid in diagnosing HCV infection for certain patient populations. Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 can now be used to confirm an active hepatitis infection, in addition to providing an accurate measurement of how much virus is in a patient’s blood, to help a physician determine the best course of treatment, according to the company. This expanded indication is in addition to its approved use as a viral load test to help physicians assess a patient’s response to antiviral therapy. The real-time polymerase chain reaction-based HCV test is designed for use on Roche’s fully automated COBAS AmpliPrep/COBAS TaqMan System.
Stimwave has received FDA 510(k) clearance for its StimQ Peripheral Nerve Stimulator (PNS) System for relieving severe intractable chronic pain of peripheral origin. The implant is placed next to peripheral nerve locations where pain is originating, according to the company. It wirelessly delivers small pulses of energy to electrodes placed at the peripheral nerve. The device is powered by a small, flexible and wearable external fabric patch unit. The company previously received FDA clearance for the Freedom-8A/4A Spinal Cord Stimulation System, which utilizes the same technology specifically for back and leg pain.
FDA has cleared a Vermillion 510(k) for its Overa OVA1 test for determining ovarian cancer risk in conjunction with independent clinical and imaging assessment prior to planned surgery for a women with a pelvic mass. The second generation OVA1 test replaces two of the five OVA1 biomarkers in the original test with HE4 and FSH in order to improve specificity and reduce the need for physicians to determine menopausal status when interpreting the test. The test is run on a single Roche Cobas 6000 platform, and stratifies patients into low- or high-risk of malignancy on a scale of zero to 10. It measures the levels of five proteins found in the blood and then uses a proprietary software called OvaCalc to calculate the single score.
HUMAN DRUGS
FDA has approved an Apotex ANDA for a generic copy of Merck’s Nasonex (mometasone furoate) Nasal Spray, indicated for treating nasal symptoms of seasonal allergic and perennial allergic rhinitis in adults and pediatric patients two years of age and older. It is also indicated for preventing seasonal allergic rhinitis nasal symptoms in people 12 years of age and older, as well as treating nasal polyps in people 18 years of age and older.
Eli Lilly has received FDA approval of an NDA for Taltz (ixekizumab), indicated for treating adults with moderate-to-severe plaque psoriasis. The drug works by binding to a protein (interleukin (IL)-17A) that causes inflammation. “By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a role in the development of plaque psoriasis,” an FDA release says.
FDA has approved an Elusys Therapeutics NDA for Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with antibacterial drugs. It is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. The monoclonal antibody is designed to neutralize toxins produced by B. anthracis. The drug was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not ethical to conduct efficacy trials in humans.
FDA has approved a Teva NDA for Cinqair (reslizumab) and its use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. It is indicated for patients who have a history of severe asthma attacks despite receiving their current asthma medicines, according to an agency release. The drug is intended to be intravenously administered once every four weeks by a health care professional in a clinical setting prepared to manage anaphylaxis.