Product Approval Summaries

DEVICES

Bovie Medical has received 510(k) clearance from FDA for six new hand piece configurations that expand its J-Plasma pistol grip surgical device. The pistol grip hand piece will now be available with instrument lengths of 15cm, 33cm and 45cm, in addition to the existing length of 27cm. Also, the new length hand pieces will each be available with a new needle configuration, as well as the standard blade configuration, the company says. The laparoscopic J-Plasma hand piece is used for soft tissue coagulation and cutting during surgery.

NxThera, Inc. has received FDA 510(k) clearance for its Rezūm System to treat benign prostatic hyperplasia (BPH). According to the company, the Rezūm System uses radiofrequency energy to transform sterile water into stored thermal energy in the form of vapor, or steam. This water vapor is convectively delivered directly into the obstructive prostate tissue that causes BPH, where condensation releases enough thermal energy to gently and immediately denature the targeted prostate tissue cells to cause necrosis, the company says and the treated tissue is absorbed by the body’s natural immune system.

FDA has cleared a Quest Diagnostics 510(k) to add a genital swab claim to its Simplexa HSV (herpes simplex virus) 1 & 2 Direct molecular test on 3M’s Integrated Cycler. The expanded labeling adds to its initial clearance from 2014 that allowed the test to use cerebrospinal fluid from patients suspected of HSV central nervous system infection, including encephalitis, which can be caused by infection with herpes simplex 1 or 2 virus, according to the company. The new clearance covers seven immunodiagnostic tests from Quest subsidiary Focus Diagnostics for aiding in herpes simplex viruses detection. “Like other Simplexa Direct tests, the Simplexa HSV 1 & 2 Direct test is a molecular test that uses a proprietary process that eliminates nucleic acid extraction, providing test results in about an hour,” the company says.

Teleflex has received FDA 510(k) clearance to market its Arrow Triple Lumen Pressure Injectable Acute Hemodialysis Catheter that is intended to reduce vascular access related complications. The device is available in the company’s ErgoPack System, which it describes as a human factors research–based vascular access insertion system designed to provide defense against known sources of bloodstream and reduce procedure times. Each ErgoPack contains a maximal barrier kit (mask with eye shield and surgical cap/gown) and a 21-step insertion checklist.

FDA has approved Waltham, MA-based Tesaro Inc.’s Varubi (rolapitant) for preventing delayed phase chemotherapy-induced nausea and vomiting. The drug is approved for use in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing cancer chemotherapy. Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist, according to an agency news release. “Activation of NK-1 receptors plays a central role in nausea and vomiting induced by certain cancer chemotherapies, particularly in the delayed phase,” it says.

HUMAN DRUGS

FDA has approved an AstraZeneca supplemental NDA for Brilinta (ticagrelor) tablets and a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With the expanded indication, the drug is now approved to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome, according to the company.

FDA has approved a Wellstat Therapeutics NDA for Xuriden (uridine triacetate), the first approved treatment for patients with hereditary orotic aciduria, a rare metabolic disorder that has been reported in about 20 patients worldwide. “The disease is due to a defective or deficient enzyme, which results in the body being unable to normally synthesize uridine, a necessary component of ribonucleic acid (RNA),” an FDA news release says. “Signs and symptoms of the disease include blood abnormalities (anemia, decreased white blood cell count, decreased neutrophil count), urinary tract obstruction due to the formation of orotic acid crystals in the urinary tract, failure to thrive, and developmental delays.”