FDA Clears TFX’s Latest Arrow PICC (BCR) (CFN) (COV) (TFX)

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Teleflex Incorporated (TFX), a global leader in medical devices used in critical care and surgery, recently announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to market its pressure injectable Arrow PICC preloaded with Arrow VPS Vascular Positioning System Stylet.

According to the company, Arrow VPS with real-time intravascular Doppler, ECG and advanced algorithmic logic allows clinicians to discard the otherwise mandatory chest X-ray. It also saves loading time for the catheter. The Arrow PICC powered by Arrow VPS Stylet is designed to meet the changing needs of clinicians by curtailing the risk of infection and unforeseen needle sticks at insertion.

Teleflex’s newest Arrow PICC will enhance its line of vascular access products in its largest segment – Critical Care. Revenues from the Critical Care segment edged up 0.2% year over year to $254.1 million (66% of the total revenues) in the second quarter. Higher sales for vascular access products along with anesthesia and urology products led to segment growth.

Management believes that performance in the most recent quarter validates the company’s focus on boosting top-line growth and enhancing its product portfolio. Teleflex continues to build its Arrow brand to strengthen its Critical Care franchise. The Arrow line of products is currently the company’s foremost brand.

Earlier this month, Teleflex was awarded an innovative technology agreement by Novation for the Arrow VPS Vascular Positioning System. The agreement, effective from September 1, 2012, encompasses the VPS console and stylets, as well as pre-loaded stylets. It is binding through three years.

Limerick, Pennsylvania-based Teleflex’ focus on profitable and consistent growth is expected to yield results, helped by demographic trends and barriers to entry in the industry. The recent divestiture of its OEM Orthopedic division is expected to aid the company’s strategy of new product introduction, and investment in innovative technologies. This might accelerate Teleflex’s top-line in the years ahead.

However, Covidien (COV), C.R. Bard (BCR) and CareFusion (CFN), which operate in similar business segments, present a tough competitive landscape for Teleflex. Additionally, the company operates in a stringent regulatory environment. The demand for its products is susceptible to healthcare reimbursement systems in the domestic as well as the international market.

Teleflex currently retains a Zacks #3 Rank, which translates into a short-term Hold rating.

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