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