Abbott’s Rx Herculink Elite

Renal stent system begins U.S. shipments following PMA supplement approval, announced Aug. 10. The device is the first cobalt chromium stent available in the U.S. for a renal indication, according to the company. The system, which includes the balloon-expandable stent pre-mounted on a rapid exchange delivery system, is designed to treat renal artery stenosis and is indicated for patients following sub-optimal angioplasty of a lesion located within 10 mm of the renal ostium, and with a reference vessel diameter of 4.0-7.0 mm. The device is available in lengths of 12, 15 and 18 mm. The approval was supported by the firm’s 202-patient HERCULES trial, which demonstrated that Rx Herculink Elite is safe and effective in patients with renal artery stenosis and uncontrolled hypertension. (See “ Also see "Research In Brief" - Medtech Insight, 16 May, 2011. ” – “The Gray Sheet” May 16, 2011.) Rx Herculink Elite has been available in Europe since 2007 for peripheral indications, Abbott noted.

VeraLight’s Scout DS

Non-invasive diabetes screening device will debut in the fourth quarter in Europe following CE mark approval, announced July 28. Indicated for screening of adults who are at risk for prediabetes (impaired glucose tolerance) and/or type 2 diabetes, it works by measuring skin fluorescence within a patient’s forearm. Unlike current screening methods, Scout DS is intended to require no blood draw, no fasting and no waiting for a lab result, according to the company. VeraLight touts the system as “the first non-invasive test that can replace conventional blood-based diabetes screening.”

The Albuquerque, N.M., company simultaneously announced completion of a $5 million “Series D” financing round to support the upcoming European launch.

In the U.S., VeraLight plans to begin a multi-site pivotal trial early next year, and file a PMA in the fourth quarter of 2012, VeraLight told “The Gray Sheet.”

GE Healthcare’s Optima CT660

Compact computed tomography system debuts in the U.S. following receipt of 510(k) clearance, announced Aug. 8. The “next-generation” CT scanner is designed to use about 60% less energy than previous-generation systems and reduce the required x-ray dose by up to 40% without sacrificing image quality, the company claims. The platform is scalable from 32 to 128 slices and allows imaging for patients in a variety of clinical settings, including cardiac, neurological, emergency room and routine CT, according to GE Healthcare. Optima CT660 also features Dose Check technology, which alerts users prior to scanning if the estimated x-ray dose is above their institution’s set values. The system is already in use at hundreds of sites across Europe, Latin America and Asia, GE noted.

NMS Labs’ chromium and cobalt testing

Diagnostic services firm announces U.S. availability of chromium and cobalt testing of blood, serum/plasma and urine to help assess metal exposure in patients who have been implanted with recalled metal hips. Announced Aug. 3, the testing service follows FDA’s recent ordering of post-market surveillance studies for metal-on-metal hips. (See “ Also see "FDA Orders Post-Market Studies On Metal-On-Metal Hips" - Medtech Insight, 16 May, 2011. ” – “The Gray Sheet” May 16, 2011.) Headquartered in Willow Grove, Pa., NMS Labs noted that “bio-monitoring of these metals may assist in the prevention of potential toxicities.”

Siemens’ rapid liver damage test

Firm’s ELF 60-minute blood test is the first automated liver fibrosis test to reach the market, the firm claims in announcing its U.K. debut Aug. 1. The test is CE-marked for use on Siemens’ ADVIA Centaur immunoassay systems. Liver fibrosis, an important indicator of chronic liver disease, refers to the accumulation of tough, fibrous scar tissue in the liver. The traditional reference standard of a needle biopsy can be painful, hazardous and erroneous, Siemens claims. By delivering results in less than an hour, Siemens says its simple blood test can aid triage and the appropriate targeting of interventions including weight loss, exercise and therapeutic interventions for patients at risk of chronic liver disease.

Cook Medical’s Word

Firm launches its Word silicone balloon catheter in the U.S. to treat cysts of the Bartholin gland following a May 510(k) clearance, the firm announces Aug. 8. The device works by holding open the lumen of a drained cyst so it can fully heal without closing again and risking further infection – a common procedure performed in OB/GYN clinics to help reduce the reoccurrence of cysts, Cook explains. The catheter can remain in place for up to 28 days as the gland heals.

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