New Low Profile PTA Balloon Allows for Easier Lesion Crossing

BIOTRONIK today announced European market release of the Passeo^®‑35 Xeo PTA (percutaneous transluminal angioplasty) balloon catheter. Compared to other available PTA balloons¹, the device offers physicians improved crossability, excellent trackability and pushability in a wide range of sizes.

“The new Passeo-35 Xeo balloon handled impressively well, crossing easily even in an occlusive lesion,” said Dr. Gerd Grözinger, Associate Professor and Head of Interventional Radiology/Angiology at the University Hospital Tübingen, Germany, after performing the first-in-human procedure with the balloon. “The deflation time was also very fast compared to other balloons, which can save valuable procedure time.”

To aid in challenging lesion crossing, the Passeo-35 Xeo catheter offers a low entry profile, smooth tip taper, and up to 19.5% more pushability compared to competitors, facilitating improved catheter navigation in the peripheral vasculature.^1,2 Catering to a full range of lesion sizes, the device is available in balloon diameters from 3.0 to 12.0 mm and lengths of up to 250 mm, with usable catheter lengths of 90, 130 and 170 cm. Additionally, the Passeo-35 Xeo catheter is fully 5F compatible for balloon sizes up to 7.0 mm in diameter and 250 mm in length.

“Our new generation of peripheral balloons is another great example of how high quality engineering can contribute to incremental improvements in the treatment of peripheral artery disease,” said Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. “The Passeo-35 Xeo catheter provides a new PTA option for interventionalists with a greater size range and improved delivery."

The Passeo-35 Xeo balloon is indicated to dilate stenosis in the iliac*, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It is also recommended for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.** Passeo-35 Xeo is the platform for BIOTRONIK’s recently released Dynetic^®-35 balloon-expandable cobalt chromium stent system, aiding in the stent’s excellent deliverability with 6F sheath compatibility for the full size range.

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References:

1. BIOTRONIK data on file.

2. Compared to leading competitors’ 6.0x200 mm balloon size. Passeo, Xeo and Dynetic are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

*Note for Australia: Passeo-35 Xeo not approved by Therapeutic Goods Administration for use in the common iliac arteries.

**Indication as per IFU.