Technology | Catheters | March 02, 2017

Teleflex Announces 510(k) Clearance and U.S. Launch of TrapLiner Catheter

Specialty catheter combines the features of a guide extension catheter with new guidewire trapping capabilities in a single device

Teleflex, FDA 510k clearance, TrapLiner Catheter, U.S. launch

March 2, 2017 — Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch of the TrapLiner Catheter.

The TrapLiner Catheter was developed by Vascular Solutions Inc., which was acquired by Teleflex on Feb. 17, 2017.

The TrapLiner Catheter is similar in design to Vascular Solutions’ popular GuideLiner Guide Extension Catheter, with the added feature of an integrated balloon for trapping a standard 0.014-inch guidewire within a guide catheter. The TrapLiner Catheter can be used as an alternative method to the trapping technique that requires the use of a percutaneous transluminal coronary angioplasty (PTCA) balloon to exchange an existing over-the-wire catheter while maintaining guidewire position. The technique of guidewire trapping for catheter exchange is most commonly performed in complex interventional procedures. The device is offered in three different sizes: 6, 7, and 8 Fr.

“The TrapLiner is a one-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,” said Dimitri Karmpaliotis, M.D., Ph.D., director of CTO, complex and high-risk angioplasty at Columbia University Medical Center, who was the first to use the device in the United States. “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.”

The TrapLiner Catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of the guidewire within the vasculature.

For more information: www.teleflex.com


Related Content

Feature | Cath Lab | Kyle Hardner

Since receiving FDA approval in 2016, intravascular lithotripsy (IVL) systems have grown in popularity among ...

Home November 14, 2025
Home
News | Cath Lab

Nov. 11, 2025 — FastWave Medical has successfully completed enrollment in its 30-patient coronary feasibility study and ...

Home November 13, 2025
Home
News | Cath Lab

Oct. 28, 2025 — Results from the first-of-its-kind randomized PROCTOR trial found that a strategy of saphenous vein ...

Home November 04, 2025
Home
News | Cath Lab

Oct. 27, 2025 — Results from the PREVUE-VALVE study suggest that there are currently at least 4.7 million people aged 65 ...

Home October 29, 2025
Home
News | Cath Lab

Oct. 25, 2025 — Medtronic plc has announced the launch of the Stedi Extra Support guidewire, designed to enhance ...

Home October 28, 2025
Home
News | Cath Lab

Oct. 27, 2025 — Elixir Medical, a developer of technologies to treat cardiovascular disease, has announced new clinical ...

Home October 28, 2025
Home
News | Cath Lab

Oct. 22, 2025 — Heartflow, Inc. has introduced Heartflow PCI Navigator, the newest addition to the Heartflow One ...

Home October 23, 2025
Home
News | Cath Lab

Oct. 15, 2025 — Stereotaxis recently announced it has obtained CE Mark in Europe and submitted a 510(k) application to ...

Home October 16, 2025
Home
News | Cath Lab

Oct. 7, 2025 — Medtronic has announced the full distribution of the Neuroguard IEP System (Neuroguard) after a ...

Home October 07, 2025
Home
News | Cath Lab

Sept. 22, 2025 — Nicklaus Children's Heart Institute in Miami, Florida, is now offering bedside transcatheter patent ...

Home September 23, 2025
Home
Subscribe Now