Data Presented for Biotronik's Passeo-18 Lux DCB and Pulsar-18 BMS for Lower Limb Intervention

September 12, 2016—Biotronik announced that findings on the efficacy of its lower limb intervention portfolio were presented during a symposium at CIRSE 2016, the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe held September 10–14 in Barcelona, Spain. 

According to the company, encouraging data were presented for the company’s Pulsar-18 bare-metal self-expanding (BMS SE) stent as well as for the Passeo-18 Lux drug-coated balloon (DCB), both as stand-alone treatments and together in a combination treatment of superficial femoral artery (SFA) disease.

Biotronik stated that the 12-month interim results of BIOFLEX PEACE all-comers registry show that the Pulsar-18 BMS SE stent alone continues to be an effective treatment option in the SFA. The primary patency rate of 75% and freedom from target lesion revascularization (TLR) of 93.1% confirm the results of previous Pulsar studies. Additionally, 12-month data on the first 200 patients (of > 850 enrolled) in the BIOLUX P-III all-comers registry support earlier findings in establishing Passeo-18 Lux DCB’s efficacy. The interim data showed a freedom from clinically driven TLR of 94%.

The company also reported that Biotronik Combination Therapy continues to show promise. This approach allows treatment of target lesions with a DCB in combination with a Pulsar BMS SE stent in segments where scaffolding support is required. Interim data from the BIOLUX 4EVER study for 90 patients demonstrated primary patency at 12 months of 88.9% and a freedom from TLR of 92.5%. This is in line with data previously reported for Biotronik Combination Therapy at the same analysis timepoint.

Koen Deloose, MD, a Lead Investigator for the BIOLUX 4EVER study commented in the company’s announcement, “It is notable that the treatment of lesions with both Passeo-18 Lux DCB and Pulsar BMS SE stent during the same intervention leads to numerically similar patency rates for those obtained with drug-eluting stents. It remains to be seen how this looks in the mid to long term, and also whether using DCB first or BMS first makes any difference with regard to clinical outcomes.” Dr. Deloose is from AZ Sint-Blasius in Dendermonde, Belgium.

Passeo-18 Lux is a combination device for treating de novo and restenotic lesions in the infrainguinal arteries. In January 2014, Biotronik announced the release the device in all countries recognizing CE Mark approval. In January 2016, Biotronik announced that it had received European CE Mark approval for smaller diameters of the Passeo-18 Lux DCB: the 2- and 2.5-mm sizes are designed to facilitate DCB treatment of below-the-knee arteries with an 0.018-inch platform. 

The Passeo-18 Lux DCB device is based on the company’s Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of a paclitaxel and butyryl-tri-hexyl citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue.

The Pulsar-18 is available in diameters of 4 to 7 mm, and all deliverable through a 4-F sheath, advised Biotronik.