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Clinical Studies

Committed to supporting further developments in cardiology, BIOTRONIK has been deeply involved in conducting clinical trials. Our scientific activities encompass a variety of topics in the field of cardiac rhythm management and cardiovascular intervention. In collaboration with international medical experts, we strive to continuously improve the diagnosis and treatment of cardiac and vascular diseases.

The databases below provide an overview of BIOTRONIK’s studies in cardiac rhythm management and cardiovascular intervention, along with related publications and resources.

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68 Clinical Studies

4EVER

Physician-initiated trial investigating the safety of the full 4F endovascular treatment approach of infra-inguinal arterial stenotic disease

At-Home

Remote Management of Pacemaker Patients with Biennial In-clinic evaluation: Continuous Home Monitoring in the Japanese at Home Study. A Randomized Clinical Trial

Watanabe E ET AL., CIRCEP 2020 May;13(5):e007734
doi: 10.1161/CIRCEP.119.007734

BERN

Evaluate long segment (> 120 mm) complex femoro-popliteal disease with Pulsar stent stratified for Critical Limb Ischaemia vs. Intermittent Claudication

BIO-RESORT

Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population

BIO4AMB

Comparing the use of 4F- versus 6F-compatible devices for ambulatory peripheral vascular interventions

BIOFLEX PEACE

Evaluating the safety and efficacy of the Pulsar-18 self-expanding stent for femoropopliteal lesions with optional drug-coated balloon angioplasty in a real-world, all-comers population

BIOFLEX-COF

Investigating the influence of high versus low chronic outward force self-expanding nitinol stents in femoropopliteal occlusive arterial lesions

BIOFLEX-I

Prospective, international, multi-center, investigational device exemption trial evaluating BIOTRONIK Astron nitinol self-expanding stent for iliac arteries

BIOFLOW-I

First-in-man experience with a drug-eluting stent in de novo coronary artery lesions

BIOFLOW-II

Study of the Orsiro Drug Eluting Stent System

BIOFLOW-III

Investigating Orsiro drug-eluting coronary stent

BIOFLOW-V

Randomized Clinical Trial Comparing Orsiro1 Drug-Eluting Stent with Xience2 DES

BIOLUX 4EVER

Evaluating outcomes after treating stenotic or occluded femoropopliteal lesions with the Passeo-18 Lux DCB followed by Pulsar-18 BMS

BIOLUX AV

Assessing the safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access

BIOLUX P-I

Clinical trial to assess the safety and performance of the coated Passeo-18 Lux paclitaxel-releasing PTA balloon catheter versus the uncoated Passeo-18 balloon catheter for treatment of stenosis of the femoropopliteal arteries

BIOLUX P-I/P-II/P-III Safety Analysis

To collect long-term clinical data on patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB

BIOLUX P-II

First-in-human study to assess the safety and performance of the Passeo-18 Lux drug-coated balloon vs. the uncoated Passeo-18 balloon catheter in patients with stenosis and occlusion of the infrapopliteal arteries

BIOLUX P-III

Investigating safety and efficacy of Passeo-18 Lux in an all-comers real-world population with up to Rutherford 6 disease in the infrainguinal arteries

BIOLUX P-III BENELUX

Investigating the safety and efficacy of Passeo-18 Lux DCB for the treatment of isolated popliteal artery lesions

BIOLUX P-IV CHN

Investigating the safety and efficacy of Passeo-18 Lux DCB for the treatment of isolated popliteal artery lesions

BIOMAG-I

A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study

BIOMONITOR III Pooled Analysis

New Generation Miniaturized Insertable Cardiac Monitor with a Long Sensing Vector: Insertion Procedure, Sensing Performance, and Home Monitoring Transmission Success in a Real-World Population

Deneke T et al., Heart Rhythm O2, 2022

BIONETIC-I

Evaluating safety and effectiveness of Dynetic-35 balloon-expandable stent for the treatment of atherosclerotic disease in the iliac arteries

BIONETIC-I TRA

Evaluating the safety and feasibility of using the Dynetic-35 stent via a transradial approach to treat iliac artery lesions