BIOTRONIK announces new product additions to create a broader, stronger PTA balloon portfolio

Vascular Intervention

BUELACH, Switzerland, October 2, 2013 – BIOTRONIK announced today the launch of the Passeo-35 0.035” OTW PTA balloon Line Extension and the Passeo-35 HP high pressure PTA (percutaneous transluminal angioplasty) balloon. The Passeo-35 0.035” OTW PTA balloon is now also available in lengths of up to 200mm and the Passeo-35 HP high pressure PTA balloon is designed for arterio-venous dialysis fistulea application.


Passeo-35 0.035” PTA balloon

Passeo-35 is part of BIOTRONIK’s leading lower limb portfolio. The availability of balloon lengths of up to 200mm in diameters 3-7mm offers physicians the potential to dilate longer disease segments in lower limb vessels with fewer balloon inflations, which may reduce potential barotrauma caused by multiple inflations and may shorten procedure times. In addition, Passeo-35 has an extremely low profile, with a measurement of 7mm x 200mm allowing for balloon compatibility with a 5F introducer sheath, and an excellent secondary profile. The addition of long balloon lengths also creates outstanding synergy with BIOTRONIK´s Pulsar-35 self-expanding stent.

Passeo-35 HP 0.035” High Pressure PTA balloon

The Passeo-35 HP 0.035” High Pressure PTA balloon is designed to treat vessel segments that require high pressure dilatation to efface resistant, often fibrotic stenoses.

Fibrotic stenoses are commonly encountered in Arterio-Venous (AV) access fistulae and grafts. Existing PTA balloon treatment options can have compromised flexibility or a bulky profile, or display instability at higher pressures. Passeo-35 HP is designed to deliver high-rated burst pressures of up to 27 atmospheres with uncompromised balloon flexibility. This results from the use of a conformable yet highly durable balloon material, minimizing the risk of vessel straightening but with the strength to dilate resistant lesions. Passeo-35 HP is available in diameters from 3-12mm and in balloon lengths from 20-100mm.

“These latest additions to our unique peripheral intervention portfolio underline BIOTRONIK’s commitment to delivering dedicated, innovative devices in line with the needs and expectations of interventional operators,” commented Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention. “Furthermore, our PTA balloon portfolio is now one of, if not the, strongest and most comprehensive available.”


As one of the world’s leading manufacturers of cardiovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million heart patients around the world have received BIOTRONIK implants, designed to save and improve the quality of their lives. Since its development of the first German pacemaker in 1963, BIOTRONIK has launched several innovations into the market—including remote monitoring with BIOTRONIK Home Monitoring® in 2000 and the world’s first implantable cardioverter-defibrillators and implantable heart failure therapy devices with ProMRI® technology, approved for MR scanning, in 2012. This year BIOTRONIK is celebrating its 50th anniversary.

For more information, visit:

Manuela Schildwächter
Global Communications Manager
Woermannkehre 1
12359 Berlin
Tel. +49 (0) 30 68905 1466