FDA Nod for Teleflex's EZ-Blocker

Teleflex Incorporated ( TFX - Snapshot Report ) , a global leader in medical devices used in critical care and surgery, recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Rusch EZ-Blocker Disposable Endobronchial Blocker. The EZ-Blocker Endobronchial Blocker had previously received the European CE Mark approval.

The innovative EZ-Blocker Endobronchial Blocker will enable safer lung isolation and one lung ventilation. Its novel features will enhance standards of care by reducing the risk of dislocation during surgery.

Teleflex’s EZ-Blocker Endobronchial Blocker will enhance its anesthesia portfolio in its largest segment: Critical Care. The approval will also extend the company’s available line of differentiated Rusch and Sheridan brands of endotracheal and endobronchial products.

We note that Teleflex has received quite a few approvals lately. The company obtained clearance for its Arrow FlexBlock continuous peripheral nerve block catheter and pressure injectable Arrow PICC preloaded with Arrow VPS Vascular Positioning System Stylet, among others. These offerings will expand the product portfolio of the Critical Care segment.

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 of 2012.

In the most recent quarter, Teleflex closed four innovative technology acquisitions including the acquisition of the EZ-Blocker line of products for $3.3 million in April 2012.

While acquisitions remain the most important part of the company’s growth strategy, the clearance reflects its aggressive strategy of portfolio extension to transition into a pure-play medical technology company.

Limerick, Pennsylvania-based Teleflex’s 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 will accelerate Teleflex’s top-line in the years ahead.

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

We currently have a long-term Neutral recommendation on Teleflex. The stock currently retains a Zacks #3 Rank, which translates into a short-term Hold rating.