Tag: Biotronik
US FDA Breakthrough Device designation granted for Biotronik’s Freesolve BTK resorbable...
Biotronik has been granted Breakthrough Device designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold...
Two-year BIOPACT randomised controlled trial analysis demonstrates “persistent excellence” for low-profile...
Biotronik has announced the presentation of two-year results from the investigator-initiated BIOPACT randomised controlled trial (RCT) by principal investigator Koen Deloose (AZ Sint-Blasius Hospital,...
Biotronik announces two-year results from BIOLUX P-III BENELUX all-comers registry
Biotronik recently announced two-year-results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (UZ Ghent, Ghent, Belgium) at the Cardiovascular...
Biotronik announces one-year subgroup results from BIOPACT RCT
Biotronik has announced one-year subgroup results from the investigator-initiated BIOPACT randomised controlled trial (RCT), which were presented by principal investigator Koen Deloose (AZ Sint-Blasius,...
Biotronik launches Oscar multifunctional peripheral catheter at LINC 2023
Biotronik today announced the limited release of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter and start of promotional activities at this...
BIOPACT RCT suggests Passeo-18 Lux DCB non-inferior to IN.PACT Admiral DCB
Koen Deloose (Dendermonde, Belgium) talks to Vascular News about the key one-year data from the BIOPACT randomised controlled non-inferiority trial, which evaluated the safety...
Vascular News’ top 10 most popular stories of February 2023
February's top 10 includes the announcement that Abbott is to acquire Cardiovascular Systems, results of the PRESERVE study on the safety and effectiveness of...
Biotronik launches Oscar multifunctional peripheral catheter
Biotronik has announced the US Food and Drug Administration (FDA) 510(k) clearance and CE mark of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional...
Biotronik’s Pulsar-18 T3 peripheral self-expanding stent system receives FDA approval
Biotronik recently announced that it has received US Food and Drug Administration (FDA) approval of its Pulsar-18 T3 peripheral self-expanding stent system. Full US...
New data on Biotronik’s Passeo-18 Lux DCB presented at LINC 2022
Biotronik recently announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC)...
Five-year patient-level data confirm safety of Passeo-18 Lux paclitaxel DCB
New long-term data presented at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK) demonstrate the safety of Biotronik’s Passeo-18 Lux paclitaxel drug-coated...
Vascular News’ top 10 most popular stories of September 2021
September's top 10 features five-year ACST-2 results, a new tool to assess amputation risk following popliteal vascular injury, and an interview highlighting the questions...
First patient enrolled in BIONETIC-I study of iliac artery treatment with...
Biotronik has announced the first patient enrolment in the BIONETIC-I study of the safety and efficacy of the Dynetic-35 cobalt chromium balloon-expandable stent system...
BIOPACT head-to-head non-inferiority randomised controlled trial completes enrolment
Biotronik is proud to announce the completion of enrolment of the investigator-initiated BIOPACT randomised controlled trial (RCT). This non-inferiority study evaluates the safety and...
Biotronik expands range of peripheral introducer sheaths
Biotronik has announced the expansion of the Fortress reinforced introducer sheath line, which is now available in 7- and 8Fr-compatible sizes in the USA...
BIOLUX AV trial demonstrates safety and efficacy of Passeo-18 Lux DCB...
Recent data from the investigator-initiated, randomised controlled trial (RCT), BIOLUX AV, showed that the treatment of dysfunctional haemodialysis access with Biotronik's Passeo-18 Lux drug-coated...
Biotronik’s Passeo-35 Xeo PTA balloon catheter is now available in Europe
Biotronik today announced European market release of the Passeo-35 Xeo percutaneous transluminal angioplasty (PTA) balloon catheter. A company press release states that, compared to...
Dynetic-35 balloon expandable cobalt chromium iliac stent system gains CE mark
Dynetic-35, the balloon-expandable cobalt chromium iliac stent system from Biotronik, is now commercially available in Europe. Indicated for the treatment of de novo or...
Positive results for Orsiro coronary drug-eluting stent out to three years
Biotronik has announced three-year data from the Bioflow-V trial, which was presented recently at the 2020 Cardiovascular Research Technologies (CRT) conference. The three-year follow-up...
Proximo Medical named commercialisation partner for Biotronik’s PVI portfolio in select...
According to a press release, Proximo Medical has been announced as the commercial partner for Biotronik's peripheral vascular intervention (PVI) platform in select US markets.
Proximo Medical is...
CIRSE 2019: New data show high chronic outward force causes significantly...
Twelve-month results of the BIOFLEX COF trial have demonstrated that the implantation of stents with low chronic outward force (COF) was associated with less...
Biotronik expands peripheral portfolio with a new treatment tool for interventions...
Biotronik has launched the Carnelian support catheter, designed to improve the access for treatment of tortuous and highly calcified lesions. Carnelian support is indicated...
Passeo-18 Lux DCB remains safe and effective at two years with...
Two-year data on the Passeo-18 Lux drug-coated balloon (DCB; Biotronik) continue to validate its safety and effectiveness in intra-inguinal arteries. Gunnar Tepe from the...
Biotronik introduces the first tri-axial 4F low-profile stent system
Biotronik has presented the company's Pulsar-18 T3 stent system for the first time during the Leipzig Interventional Course (LINC; 22–24 January, Leipzig, Germany).
The Pulsar-18...
Data from multiple studies support concept of low metal burden therapies...
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce restenosis rates, according to results from various Biotronik studies...
Full US availability of Biotronik Pulsar-18 self-expanding stent announced
Getinge has announced the full US market release of the Pulsar-18 stent from Biotronik. Pulsar-18 is the only available self-expanding stent for blocked superficial...
Biotronik BIOFLEX-1 trial demonstrates safety and efficacy of Pulsar-18 SFA stent
Biotronik has announced that 12-month data from the BIOFLEX-I study have demonstrated the safety and efficacy of the company’s Pulsar-18 self-expanding stent for blocked...
Encouraging results for the Biotronik Passeo-18 Lux drug-coated balloon and Pulsar-18...
Interim data presented at the 2017 Leipzig Interventional Course (LINC; 24-27 January, Leipzig, Germany) has demonstrated encouraging results for Biotronik dedicated lower limb intervention portfolio.
“Currently...
