Biotronik’s Passeo-18 Lux DCB Evaluated in Two Studies of Challenging Femoropopliteal Lesions

July 6, 2022—Biotronik announced the presentation of two studies on the performance of its Passeo-18 Lux drug-coated balloon (DCB) catheter at LINC 2022, the Leipzig Interventional Course held June 6-9 in Leipzig, Germany.

Principal Investigator Michael Lichtenberg, MD, presented 12-month outcomes from BIO REACT, the Biotronik Response Adapted Combination Therapy Pilot Study.

Professor Marianne Brodmann, MD, of the Medical University Graz, Austria, reported the results of the Passeo-18 Lux DCB Long Lesion cohort, which combines the BIOLUX P-III all-comers registry’s long lesion subgroup and the BIOLUX P-III Spain study evaluating device performance in TASC C and D lesions > 15 cm.

According to Biotronik, the BIO REACT study was designed to better understand when and where a stent is needed following a DCB for the treatment of femoropopliteal artery lesions in patients with peripheral artery disease. The Bio React therapy combines the Passeo-18 Lux DCB with the company’s Pulsar-18 T3 thin-strut stents.

The company advised that the data from the small cohort showed that the use of intraoperative duplex-ultrasound did not improve the identification of flow-limiting dissections. However, the findings demonstrated that using the combination therapy when and where it is needed is a safe and effective treatment of femoropopliteal lesions that leaves less metal behind.

As summarized in the company’s press release, the 12-month BIO REACT data included the following:

• 94.8% rate of freedom from clinically driven target lesion revascularization (fCD-TLR)
• 81.5% rate of primary patency
• 97.2% rate of survival
• No major target limb amputation

“Identifying when to place a stent remains a complex issue, but the 12-month outcomes of the BIO REACT pilot study demonstrate that the Passeo-18 Lux DCB is an effective standalone therapy with a fCD-TLR rate of 94%,” commented Dr. Lichtenberg in the press release. He is Chief Physician, Arnsberg Vascular Center at Karolinen Hospital in Arnsberg, Germany.

Prof. Brodmann presented findings from the pooled analysis that included 159 patients with long and complex femoropopliteal lesions that were treated with the Passeo-18 Lux DCB.

As outlined by the company, the device showed good results in this real-world, challenging patient population (40.3% diabetes mellitus, 32.7% critical limb ischemia):

• 84.4% fCD-TLR
• 83.9% freedom from major adverse events
• 98.6% freedom from major target limb amputation
• 93.3% amputation-free survival

Consistent with the results presented from the BIO REACT study, Passeo-18 Lux DCB was shown to be an effective standalone treatment for complex lesions, with 60% of lesions not needing bailout stenting despite the long lesion length (mean lesion length, 24.9 cm), noted the press release.

“The treatment of long, complex TASC C and D femoropopliteal lesions with Passeo-18 Lux DCB as a standalone therapy is clearly shown to be safe and effective,” commented Prof. Brodmann on the results in Biotronik’s press release.

The company advised that randomized controlled trials and all-comers registries have investigated the safety and efficacy of Passeo-18 Lux DCB in the treatment of more than 1,900 patients with peripheral artery disease in the infrainguinal arteries.

Biotronik noted that convincing long-term performance and safety data were presented by Ron Waksman, MD, at the Charing Cross International Symposium held April 26-28 in London, United Kingdom.