BIOTRONIK’s Bare Metal Stent Proves Effective and Versatile as Standalone and in Combination with Drug-Coated Balloon in 12-Month Results of BIOFLEX PEACE and BIOLUX 4EVER
LONDON, United Kingdom and BUELACH, Switzerland, April 27, 2017 – BIOTRONIK’s Pulsar-18 bare metal stent (BMS) has yielded high primary patency in a real-world setting, according to the 12-month results of the BIOFLEX PEACE all-comers registry. The findings were presented yesterday at the Charing Cross Symposium in London. Outcomes of the BIOLUX 4EVER study were also presented on the main stage, revealing 12-month results numerically comparable to drug-eluting stents (DES) when the Pulsar-18 was used in combination with the Passeo-18 Lux drug-coated balloon (DCB)
BIOFLEX PEACE All-Comers Registry
The 12-month results from BIOFLEX PEACE revealed findings for the first time for the entire patient cohort for the Pulsar-18 in the treatment of femoral popliteal lesions in a real-world setting. During the presentation at the Charing Cross Symposium, lead investigator Dr. Michael Lichtenberg highlighted the 73.6% primary patency and 96.2% freedom from clinically driven target lesion revascularization (fTLR) in 164 patients. “These results are in line with already published data for the Pulsar stent from controlled trials, thus confirming the stent’s efficacy for a broader range of patients and lesions,” commented Dr. Lichtenberg, Vascular Center Clinic, Arnsberg, Germany.
BIOLUX 4EVER Trial
In the BIOLUX 4EVER trial, physicians used the combination of the Pulsar-18 BMS and the Passeo-18 Lux DCB to treat superficial femoral artery (SFA) lesions. Dr. Koen Deloose, AZ Sint-Blasius, Dendermonde, Belgium presented the full 12-month (395 days) outcomes of this trial, with 89.9% primary patency and 91.6% fTLR in a cohort of 120 patients.
“The 12-month outcomes of the BIOLUX 4EVER trial indicate the value of a combined approach that provides physicians with more options and versatility when treating SFA lesions while achieving DES-like results,” commented Dr. Deloose. “While DES is limited by the need to fully cover the lesion with a stent and fully treat the lesion with Paclitaxel, the new combination approach of a DCB and BMS means that there is now the freedom to determine how much support is necessary based on each vessel’s unique anatomy and lesion characteristics for a more tailored approach. Following full lesion coverage with the DCB, if full lesion stenting is deemed necessary, we have the results of BIOLUX 4EVER to give physicians the confidence of a good outcome; should the physician decide to minimize the metal burden, partial (focal) stenting can be used, which is not an option with DES.”
“It is very exciting to see excellent results with the Pulsar-18 in a real-world setting and to have confirmation of the highly flexible BIOTRONIK treatment approach REACT (REsponse Adapted Combination Therapy),” stated Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention. “These results further support that the combination of the Pulsar-18 BMS and Passeo-18 Lux DCB can achieve outstanding results while providing greater treatment flexibility than a drug-eluting stent.”
BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar, the world’s first 4 F compatible stent for treating long lesions; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.