On 2 October 2013, Biotronik announced the launch of the Passeo-35 0.035” OTW PTA balloon Line Extension and the Passeo-35 HP high pressure percutaneous transluminal angioplasty (PTA) 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 arteriovenous dialysis fistulae application.
The availability of balloon lengths of up to 200mm in diameters 3–7mm in the Passeo-35 portfolio 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, according to Biotronik, Passeo-35 has an extremely low profile, with a measurement of 7x200mm allowing for balloon compatibility with a 5F introducer sheath, and an excellent secondary profile. The company also said that “the addition of long balloon lengths also creates outstanding synergy with Biotronik´s Pulsar-35 self-expanding stent”.
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 arteriovenous 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 Alexander Uhl, Biotronik vice president of Marketing, Vascular Intervention. “Furthermore, our PTA balloon portfolio is now one of, if not the, strongest and most comprehensive available.”