Teleflex (NYSE:TFX) today said it won FDA 510(k) clearance for its TrapLine Catheter and saw shares tick up upon the release of 4th quarter and full fiscal year 2016 earnings that beat expectations on The Street.
The TrapLiner is intended for use in conjunction with guide catheters for accessing discrete regions of the coronary or peripheral vasculature to place or exchange interventional devices.
“The TrapLiner is a 1-of-a-kind product that combines two devices we had previously deployed independently during challenging cases into a single tool that enables the most complicated interventional procedures to be done more efficiently. The primary clinical use for the TrapLiner is during cases in which over-the-wire microcatheters are required to cross calcified lesions, navigate bifurcations, or cross tortuous anatomy. During these procedures, the TrapLiner not only provides added backup support and deep-seating for the guide catheter, but also allows the operator to maintain guidewire positioning when exchanging the microcatheter. The distinct two-in-one capability of this device is highly desirable, as it greatly enhances the efficiency of complex procedures,” Dr. Dimitri Karmpaliotis of Columbia University Medical Center, who was the 1st to use the device in the US, said in a prepared statement.
The TrapLiner is similar to Vascular Solutions GuideLiner guide extension catheter, but includes an integrated balloon for trapping a standard 0.014″ guidewire within a guide catheter, the company said.
In its earnings report, the Wayne, Penn.-based company posted profits of $61.1 million, or $1.30 per share, on sales of $513.9 million for the 3 months ended Dec. 31, for bottom-line shrinkage of 39.7% while sales grew 6.1% compared with the 4th quarter of 2015.
After adjusting to exclude 1-time items, earnings per share were $2.13, a solid 4¢ above consensus on The Street where analysts were looking for sales of $502.6 million.
For the full year, Teleflex posted profits of $237.8 million, or $4.98 per share, on sales of $1.9 billion. That equates to bottom-line losses increasing 3.2% while sales grew an equal 3.2% compared with its fiscal year 2015.
Adjusted to exclude 1-time items, earnings per share for the year were $7.34, again 4¢ ahead of consensus on The Street. Revenue fell right in line, with The Street expecting to see $1.9 billion.
“Teleflex delivered a strong finish to 2016 with revenue growth above our most recently provided guidance. During the fourth quarter, each of our segments delivered solid performances, resulting in constant currency revenue growth of 6.9% and the attainment of an adjusted operating margin of 25.0%. As we turn to 2017, thanks to stability in our end-markets, a robust product pipeline and the completion of the acquisition of Vascular Solutions ahead of our initial timetable, Teleflex is poised to deliver double-digit constant currency revenue growth and significant adjusted margin and adjusted earnings per share expansion,” chair & CEO Benson Smith said in a press release.
Teleflex released its outlook for the upcoming year, expecting to see revenue grow 10 to 11.5% over the past year, with a nice positive tick from its acquisition of Vascular Solutions. Adjusted earnings per share are expected to be between $8.00 and $8.15 for the full year, the company said.
Shares in the company have ticked up in early morning trading, up 1.9% to trade at $187.57 as of 9:57 a.m. EST.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
Use code WOMENSHEALTH to save an additional 10%.