A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported CE-mark approval and the European launch of its line of HydroSteer hydrophilic-coated nitinol guide wires.
The HydroSteer line of guide wires features a lubricious hydrophilic coating which becomes slippery when wet, thereby reducing friction and enabling physicians to more easily maneuver the wires through the patient's vessels.
The line includes a wide variety of sizes, lengths and configurations.
St. Jude said the HydroSteer family is designed to provide physicians with more control of the guide wire's tip, "allowing the physician optimal placement of the subsequent procedural tools." It said each wire in the HydroSteer line provides "excellent steerability to help physicians navigate challenging vascular structures."
Guide wires are used to gain access in a variety of cardiovascular procedures. They are used to help guide and steer a catheter (a flexible tube) through the vessels to deliver treatments, such as stents, which open blockages and restore blood flow to the heart or other parts of the body.
The company said a radiopaque polymer jacket on the wire's nitinol (nickel-titanium alloy) core enhances the physician's ability to visualize the wire's location in the vessel. The nitinol core resists kinking while providing the flexibility physicians need to advance the wire through the vasculature, it said.
In addition, a torque device enhances steerability by aiding directional control. The torque device also has received CE-mark approval and is available for separate purchase.
"With the introduction of HydroSteer, the recent launch of the TigerWire guide wire and the availability of our existing GuideRight guide wire line, physicians now may choose from a full complement of St. Jude Medical guide wires used in interventional and diagnostic procedures," said Denis Gestin, president of St. Jude's International Division. "These products reflect our commitment to providing physicians with medical devices that help them control risks and attain the best patient outcomes."
BD gets approval for C diff assay
BD Diagnostics (San Diego), a unit of BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) reported receiving the CE mark for the BD GeneOhm Cdiff molecular assay for the rapid diagnosis of patients with Clostridium difficile infection (CDI).
The company said it is the first CDI diagnostic test that offers sensitivity, simplicity and speed in one test procedure. BD also has submitted this assay to the FDA for clearance.
CE-marked for the identification of toxigenic C. difficile directly from stool specimens, the BD assay targets the toxin B gene. BD Diagnostics said it is the only CDI diagnostic test that combines high assay sensitivity with a rapid turnaround time of less than two hours.
That facilitates earlier treatment of patients suffering from CDI and earlier implementation of infection control interventions to prevent transmission of Clostridium difficile to other patients.
Until now, rapid diagnosis of CDI has been difficult since traditional methods consist of immunoassays, which lack sufficient sensitivity, and traditional "gold standard" tissue culture cytotoxicity methods require several days to yield results.
"The BD GeneOhm Cdiff assay provides a simple and rapid stool test with excellent sensitivity and specificity that allows same-day identification of toxigenic Clostridium difficile," said Thomas Davis, MD, PhD, professor of pathology and laboratory medicine at Clarian Pathology Laboratory. "This test should improve patient care because it effectively eliminates the need for multiple screening and confirmatory assays, speeds up reporting and helps avoid unnecessary antibiotic use."
In the UK, C. difficile infections have risen 40% in the last three years, infecting eight times as many patients as MRSA and killing twice as many. In the U.S., an estimated 500,000 people are hospitalized annually and more than 28,000 die from CDI. The average length of stay for a CDI patient is nearly three times longer than the average patient and excess healthcare costs exceed $1 billion.
Russian distributor for Spectral
Spectral Diagnostics (Toronto) said it has entered into an exclusive distribution agreement in Russia with BB Medical to distribute Spectral's Endotoxin Activity Assay (EAA), the only FDA-cleared assay for the measurement of endotoxin.
BB Medical will market and sell EAA throughout the Russian Federation.
"BB Medical is a leading distributor of medical technologies in Russia. Their significant market reach in this region will help to strengthen our presence in yet another geographic territory — a key component in the global commercialization strategy for our EAA product," said Dr. Paul Walker, president/CEO of Spectral Diagnostics.
He added, "Our distribution agreement with BB Medical ... is expected to be the first of several distribution agreements in new geographic territories. Ultimately, these alliances will drive the adoption of our unique product globally, both as a stand-alone product, and also in combination with therapeutics for the diagnosis, treatment and monitoring of patients with endotoxemia."
The agreement with BB Medical is a result of the company's expanded collaboration agreement with Toray Medical that was reported in May. Through that accord, Spectral may now access Toray's distributors in other geographic territories, including China, India and Canada.
Vitrolife adds shares of distributor
Vitrolife (Kungsbacka, Sweden) said it is acquiring an additional 9% of the shares in A.T.S., the distributor of its products in Italy since 1999. Vitrolife now owns 60% of the company, with an option to acquire an additional 10% within six months.
In January Vitrolife acquired 51% of the shares in A.T.S. The company said the acquisition is in line with its strategy to operate under its own management in key markets and increases the opportunities for A.T.S. to be more aggressive and be able to increase its market share in the Italian market.
The agreement includes an option for Vitrolife to acquire an additional 9% of the shares within six months and an additional 10% within 12 months of the original acquisition date, for a total of 70%.
The seller of the shares is Paolo Trabucchi, one of the founders and previously the sole owner of A.T.S.