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various families of philos cylos evia entovis estella ecuro effecta implantable pacemakers
Biotronik
Summary: The Biotronik implantable pacemakers, including Philos, Cylos, Evia, Entovis, Estella, Ecuro, and Effecta families, are used to manage cardiac arrhythmias. They are primarily used by cardiologists in both hospital and outpatient settings.
FDA Clearance Information
Pathway
PMA
Number
P950037 ↗
Decision Date
March 5, 2012
Product Code
NVZ
Device Class
Class 3
Evidence
419 studies
These Biotronik pacemakers were cleared through the FDA's premarket approval (PMA) pathway on March 5, 2012. They are classified as Class III medical devices.
What It Is
These implantable pacemakers are medical devices designed to regulate heart rhythms in patients with arrhythmias. They work by delivering electrical impulses to the heart to maintain a regular heartbeat. The devices are implanted under the skin, typically near the collarbone, and are connected to the heart via leads.
Clinical Applications
These pacemakers are commonly used in patients with bradycardia or heart block, conditions where the heart beats too slowly or with an irregular rhythm. They are used in cardiology practices, hospitals, and specialized cardiac care centers. The devices are suitable for a wide range of patients, including those with congenital heart defects or those who have undergone cardiac surgery.
Indications for Use
The FDA-cleared indication for these pacemakers involves a new laser weld process to attach connection bands to nickel pads, enhancing device reliability. They are intended for patients requiring cardiac rhythm management due to arrhythmias.
Practical Considerations
These pacemakers come in various sizes to accommodate different patient anatomies and are compatible with standard pacing leads. Implantation requires surgical expertise, and clinicians should be familiar with device programming and follow-up procedures.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Philos Cylos Evia Entovis Estella Ecuro Effecta pacemaker used for?
These pacemakers are used to manage cardiac arrhythmias by regulating heart rhythms in patients with conditions like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these pacemakers in both hospital and outpatient settings.
What are the FDA-cleared indications?
The pacemakers are indicated for patients requiring cardiac rhythm management, with a focus on a new laser weld process for enhanced device reliability.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.