Product Approval Summaries

DEVICES

FDA has cleared a 4WEB Medical 510(k) for its Lateral Spine Truss System, a 3D-printed lateral interbody fusion device. “4WEB’s proprietary truss implant technology leverages fundamental engineering principles in structural mechanics to address important clinical issues such as implant subsidence after lateral access surgery,” a news release says. The device will launch with a wide array of sizing options and integrated instrumentation. Additionally, they will feature smart single-sterile packaging to ensure sterility, improve operating room efficiencies, and allow access to global markets where sterile packaging is a requirement, the company says.

Companion Medical has received FDA 510(k) clearance for the InPen system, its wireless-enabled insulin pen and proprietary mobile application.  The device includes technology to calculate and recommend optimal dosing, track history and timing of doses, monitor insulin temperature, and track and report to the health care providers, according to the company. It is cleared in the U.S. for use with Eli Lilly’s Humalog and Novo Nordisk’ Novolog rapid acting insulins.  The InPen app is also cleared for Apple’s iOS operating system, and an Android version is planned for later this year.

FDA has cleared an Instrumentation Laboratory 510(k) for the HemosIL HIT-Ab(PF4-H) assay for use on ACL TOP Hemostasis Testing Systems for detecting antibodies associated with heparin-induced thrombocytopenia. According to the company, this severe immunologic adverse reaction to a heparin complex can cause blood clots to form, leading to venous or arterial thrombosis or death. “Diagnosis of HIT is key to positive patient outcomes and may prompt initiation of alternative anticoagulants,” it says. Unlike existing manual processes, the device is a liquid, ready-to-use immunoassay that delivers results in minutes, it adds.

 Itamar Medical has received 510(k) clearance from FDA to expand the medical indication for its WatchPAT for sleep apnea diagnosis. The clearance covers the device’s use in patients aged 12 and older. The previous clearance was for use in those aged 17 and older. WatchPAT is a small wrist mounted, home sleep test WatchPAT is the only FDA-cleared HST device that measures true sleep time and all sleep stages (wake, light sleep, deep sleep and REM sleep), according to the company. “For those patients who are waiting for a polysomnography (PSG) but can’t be tested due to sleep center backlog, WatchPAT offers an immediate solution,” it says.

Micro Interventional Devices has received FDA clearance to market its Permaseal transapical access and closure device. It allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium, according to the company.

FDA has approved a Transcend Medical PMA for the CyPass Micro-Stent System (Model 241-S), a glaucoma surgical device for use in combination with cataract surgery. The is intended to help reduce intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. The CyPass System comprises a CyPass Micro-Stent, contained within a loading device, and a stent delivery tool.  It is placed in the angle of the eye, with the proximal end extending into the anterior chamber, and the distal end residing in the supraciliary space. This allows outflow of fluid from the anterior chamber through the distal end into the supraciliary and suprachoroidal spaces, the company says.

HUMAN DRUGS

FDA has approved an AbbVie NDA for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) tablets, a once-daily, extended-release co-formulation of the active ingredients in Viekira PAK for treating patients with chronic genotype 1 (GT1) hepatitis C virus infection, including those with compensated cirrhosis (Child-Pugh A). The company notes the product is not for use in patients with decompensated cirrhosis. The drug can be used without ribavirin in GT1b patients and in combination with twice daily ribavirin in GT1a patients.

FDA has approved a Sanofi-Aventis NDA for Adlyxin (lixisenatide), a once-daily injection to improve glycemic control in adults with Type 2 diabetes. FDA says that Adlyxin should not be used to treat patients with Type 1 diabetes or patients with increased ketones in their blood or urine (diabetic ketoacidosis).

Silvergate Pharmaceuticals has received FDA approval of Qbrelis (lisinopril) Oral Solution, the first FDA-approved lisinopril oral solution. Qbrelis is indicated for treating hypertension in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.