đź“‹ FDA Reference
angiosculpt rx ptca scoring balloon catheter angiosculpt evo rx ptca scoring balloon catheter with hydrophilic coating
Spectranetics
Summary: The AngioSculpt RX PTCA Scoring Balloon Catheter is a device used in percutaneous transluminal coronary angioplasty (PTCA) to treat coronary artery disease. It is primarily used by interventional cardiologists to improve blood flow in narrowed coronary arteries.
FDA Clearance Information
Pathway
PMA
Number
P050018 ↗
Decision Date
July 7, 2023
Product Code
NWX
Device Class
Class 3
Evidence
419 studies
The AngioSculpt RX PTCA Scoring Balloon Catheter, manufactured by Spectranetics, was cleared by the FDA under PMA P050018 on July 7, 2023. It is classified as a Class 3 medical device.
What It Is
The AngioSculpt RX PTCA Scoring Balloon Catheter is a specialized balloon catheter designed to facilitate the dilation of stenotic coronary arteries during angioplasty. It features a unique scoring element that helps modify plaque and improve luminal gain. The device's hydrophilic coating enhances deliverability through tortuous vessels, making it a valuable tool in complex coronary interventions.
Clinical Applications
This device is commonly used in interventional cardiology during procedures aimed at treating coronary artery disease. It is particularly useful in cases where the coronary lesions are resistant to traditional balloon angioplasty due to calcification or fibrotic tissue. The AngioSculpt RX is often employed in catheterization labs by cardiologists to optimize stent deployment and reduce the risk of restenosis.
Indications for Use
The FDA-cleared indication for the AngioSculpt RX is as an alternate supplier for a catheter component, specifically for use in coronary angioplasty procedures. It is intended for patients with coronary artery disease requiring mechanical dilation of stenotic segments.
Practical Considerations
The AngioSculpt RX is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and is typically used in conjunction with other angioplasty tools. Proper technique involves careful navigation through the coronary vasculature to ensure precise placement and effective scoring of the lesion.
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 AngioSculpt RX PTCA Scoring Balloon used for?
It is used for dilating narrowed coronary arteries during angioplasty, particularly in challenging lesions with calcification.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs during coronary angioplasty procedures.
What are the FDA-cleared indications?
The device is indicated as an alternate supplier for a catheter component in coronary angioplasty, used to treat coronary artery disease.
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.