Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter

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Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad range of peripheral vascular applications. The product is the result of the company’s ongoing investment in a pipeline of highly differentiated whole-product solutions. Surmodics expects to make the product available for distribution in the coming months.

This new low-profile product combines our most advanced balloon technologies with Surmodics’ proprietary, low-friction, low-particulate Serene® hydrophilic coating for superb tracking, and unmatched lesion crossing performance, while delivering high pressures and a broad offering ranging from 2mm to 10mm diameter.

“We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product offerings. With the .018” Low-Profile PTA balloon catheter, we continue building upon Surmodics’ portfolio of differentiated products that are designed to advance the treatment of vascular disease,” said Gary Maharaj, President and CEO of Surmodics. “This regulatory milestone adds to the recent clearances of the Telemark™ .014” Support Microcatheter and the .014” BTK Balloon Dilatation Catheter.”

Surmodics’ whole-product solutions strategy leverages its comprehensive, vertically integrated design, development and high volume commercial production capabilities at its state-of-the-art facility in Ballinasloe, County Galway, Ireland. At this facility we control every step of the manufacturing process to produce the highest quality medical devices designed to address unmet clinical needs.

For Further Information

More on the peripheral vascular stent market in the U.S. can be found in a report series published by iData Research entitled the U.S. Market Report Suite for Peripheral Vascular Devices and Accessories. The suite covers reports on the following markets: Peripheral Vascular Stent Market, PTA Balloon Catheter Market, Atherectomy Device Market, Chronic Total Occlusion (CTO) Device Market, Embolic Protection Device Market, Stent Graft Market, Surgical Graft Market, Diagnostic and Interventional Catheter Market, Diagnostic and Interventional Guidewire Market, Introducer Sheath Market, Inferior Vena Cava Filter Market, Arteriovenous (AV) Access Thrombectomy Device Market, Vascular Closure Device Market, and Transcatheter Embolization Device Market.

Reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about peripheral vascular device market data or procedure data, register online or email us at info@idataresearch.net for a U.S. Market Report Suite for Peripheral Vascular Devices and Accessories brochure and synopsis.

iData ResearchSurmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter

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      3. Orthopedic Navigation Systems
      4. RNAV Procedures
      5. Spine Navigation Systems
    • Tables, Lights & Booms
      1. Anesthesia/Nursing Boom
      2. ASC Surgical Lighting
      3. Equipment Boom
      4. General Surgical Table
      5. Hospital Surgical Lighting
      6. Specialty Surgical Table
      7. Utility Boom
    • Video, Monitors & PACS
      1. Combination Consoles
      2. Image Management Devices
      3. Medical Photo Printers
      4. Surgical Camera Systems
      5. Surgical Light Sources
    Ophthalmics Devices
    Orthopedics
    • Arthroscopy
      1. Arthroscopes
      2. Arthroscopic Procedures
      3. Disposable Cannula
      4. Drill Guide Systems & Disposables
      5. Fluid Management
      6. Hand Instruments
      7. Radio-frequency Probes
      8. Shaver Blades
      9. Suture Passers
    • Biologics & Biomaterials
      1. Biologics Procedures
      2. Cellular Allografts
      3. Hyaluronic Acid Visco-supplementation
      4. Orthopedic Bone Graft Substitute
      5. Orthopedic Cartilage Repair
      6. Orthopedic Cell Therapy
      7. Orthopedic Growth Factor
    • Craniomaxillofacial (CMF)
      1. Bone Graft Substitutes
      2. CMF Procedures
      3. Cranial Flap Fixation
      4. Dural Repair
      5. Plate & Screw Fixation
      6. Thoracic Surgery
      7. TMJ
    • Foot & Ankle
      1. Ankle Fusion
      2. Foot & Ankle Procedures
      3. Foot Digit Implant
      4. Forefoot & Midfoot Fixation
      5. Hammertoe Device
      6. Hindfoot Device
      7. Primary Ankle Replacement
    • Hip & Knee
      1. Bone Cement
      2. Hip & Knee Procedures
      3. Hip Replacement Devices
      4. Hip Replacement Revision
      5. Hip Resurfacing
      6. Knee Cutting Block
      7. Knee Replacement Devices
      8. Knee Replacement Revision
      9. Partial Hip Replacement
      10. Partial Knee Replacement
      11. Total Hip Replacement
      12. Total Knee Replacement
    • Shoulder, Hand & Wrist
      1. Distal Radius Plates & Screws
      2. Hand Digit Implants
      3. Hemi Shoulder Implants
      4. Resurfacing Shoulder Implants
      5. Reversed Shoulder Implants
      6. Revision Shoulder Implants
      7. Shoulder Plates & Screws
      8. Total Shoulder Implants
      9. Ulnar Head Replacement
      10. Wrist Fusion
      11. Wrist Replacement
    • Spine
      1. Cervical Fixation
      2. Facet Fixation
      3. Interbody Devices
      4. MIS Instrumentation
      5. MIS Pedicle Screws
      6. MIS Sacroiliac Joint Fusion
      7. Motion Preservation Devices
      8. Spinal Electrical Stimulation
      9. Spinal Surgery Instrumentation
      10. Spine Endoscopes
      11. Spinous Process Fixation
      12. Thoracolumbar Fixation
      13. Vertebral Compression Fracture
    • Sports Medicine
      1. Achilles Tendon Repair & Reconstruction
      2. ACL/PCL Reconstruction
      3. Biceps Tenodesis Repair
      4. Hip Arthroscopy
      5. Meniscal Repair
      6. Rotator Cuff Repair & Reconstruction
      7. Shoulder Labrum Repair
      8. Sports Medicine Procedures
    • Trauma
      1. Bioabsorbable Fixation
      2. Bone Growth Stimulators
      3. Bone Pins
      4. Cannulated Screws
      5. Cerclage Cable & Trochanteric Grip
      6. Conventional Hip Screws
      7. External Fixation Devices
      8. Intramedullary Hip Screws
      9. Intramedullary Nails
      10. Plates & Screws
      11. Staple Fixation
      12. Trauma Procedures
    Patient Monitoring
    Peripheral Vascular
    • Atherectomy Devices
      1. Atherectomy Procedures
      2. By Care Settings
      3. Disposables/Consoles
      4. Laser
      5. Mechanical
    • Drug-Coated Balloons
      1. AV Access
      2. Below-the-Knee (BTK)
      3. By Balloon Length/Diameter
      4. By Care Setting
      5. By Rated Burst Pressure
      6. Drug-Coated Balloon Procedures
      7. Superficial Femoral Artery (SFA)
    • Peripheral Thrombus Management
      1. Catheter Directed Thrombolysis
      2. Peripheral Thrombus Procedures
      3. Pharmaco-mechanical Thrombectomy
      4. Traditional Thrombectomy
    • Surgical Grafts
      1. Aorta Repair
      2. Extra-Anatomical Bypass
      3. Lower Limb
      4. Surgical Graft Procedures
    • Transcatheter Embolization
      1. Embolization Coils
      2. Embolization Liquid
      3. Embolization Particles
      4. Embolization Plugs
      5. Embolization Procedures
    Respiratory Devices
    • Disposables
      1. Oxygen Cannula
      2. Oxygen Masks
      3. Resuscitators
      4. Tracheostomy Tubes
    • Nebulizers
      1. Portable Compressor/Jet
      2. Stationary Compressor/Jet
      3. Ultrasonic Mesh
      4. Vibrating Mesh
    • Oxygen Therapy
      1. Aluminum Medical Oxygen Cylinders
      2. Concentrators
      3. Oxygen Conservers
      4. Oxygen Regulator Home Care
      5. Transfilling Devices
    • Ventilators
      1. Acute Care
      2. Home Care
      3. Neonatal
      4. Non-Invasive
      5. Sub-Acute Care
    Robotics & Navigation
    • ENT Navigation
      1. Disposable/Reusable/Reposable Products
      2. ENT Navigation Procedures
      3. ENT Navigation Systems
      4. Leased & Purchased
      5. Service & Maintenance
    • MIS Robotics
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. MIS Robotic Systems
      4. MIS Robotics Procedures
      5. Service & Maintenance
    • Neurosurgery Assisted-Robotics
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Neurosurgery Robotics Procedures
      4. Robotic-Assisted Neurosurgery Systems
      5. Service & Maintenance
    • Neurosurgery Navigation
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Neurosurgery Navigation Procedures
      4. Neurosurgery Navigation System
      5. Service & Maintenance
    • Orthopedic Navigation
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Orthopedic Navigation Procedures
      4. Orthopedic Navigation Systems
      5. Service & Maintenance
    • Orthopedic Surgery Assisted-Robotics
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Orthopedic Robotics Procedures
      4. Robotic-Assisted Orthopedic Surgery Systems
      5. Service & Maintenance
    • Radiosurgery Robotics
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Radiosurgery Robotics Procedures
      4. Robotic Radiosurgery Systems
      5. Service & Maintenance
    • Spine Navigation
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Service & Maintenance
      4. Spine Navigation Procedures
      5. Spine Navigation Systems
    • Spine Surgery Assisted-Robotics
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Robotic-Assisted Spine Surgery System
      4. Service & Maintenance
      5. Spine Robotics Procedures
    • Vascular Catheter Robotics
      1. Disposable/Reusable/Reposable Products
      2. Leased & Purchased
      3. Robotic Vascular Catheter Systems
      4. Service & Maintenance
      5. Vascular Catheter Robotics Procedures
    Sleep Apnea & Diagnostics
    • Positive Airway Pressure Devices
      1. Auto-Titrating Positive Airway Pressure Devices
      2. Bi-Level Positive Airway Pressure Devices
      3. Continuous Positive Airway Pressure Devices
    Spine
    • Cervical Fixation
      1. Anterior Cervical Fixation
      2. Bioresorbable Anterior
      3. Cable/Wiring Posterior
      4. Cervical Fixation Devices
      5. Cervical Fixation Procedures
      6. Constrained Anterior
      7. Dynamic Anterior
      8. Occipito Cervical Posterior
      9. Posterior Cervical Fixation
      10. Screw/Rod Posterior
      11. Semi-Constrained Anterior
    • Interbody Fusion
      1. 3D Printed
      2. ALIF/ PLIF/ TLIF/ CIF
      3. Cervical/ Lumbar
      4. Expandable Interbody
      5. Interbody Devices
      6. Interbody Fusion Procedures
      7. Metal/ PEEK/ Machine Bone
      8. Non-3D Printed
      9. Standalone Interbody
      10. VBR/Corpectomy
    • MIS Pedicle Screws
      1. MIS Pedicle Screw Procedures
      2. Pedicle Screws
      3. Percutaneous Cannulated Pedicle Screws
      4. Retractor Cannulated Pedicle Screws
      5. Retractor Non-Cannulated Pedicle Screws
    • Motion Preservation
      1. Artificial Discs
      2. Cervical Artificial Discs
      3. Dynamic Posterior Stabilization
      4. Dynamic Stabilization Devices
      5. Interspinous Process Stabilization
      6. Lumbar Artificial Discs
      7. Motion Preservation Devices
      8. Motion Preservation Procedures
    • Other Spine
      1. Spinal Surgery Instrumentation
      2. Thoraco-lumbar Fixation
      3. Thoraco-lumbar Procedures
    • Spinal Electrical Stimulation
      1. Cervical Electrical Stimulation Devices
      2. Electrical Stimulation Procedures
      3. Lumbar Electrical Stimulation Devices
      4. Spinal Electrical Stimulation Devices
    • Spine Biomaterials
      1. Autograft/ Allografts/ Synthetics
      2. Bone Graft Substitutes
      3. Bone Marrow Aspirate Concentrate
      4. Cervical Spine Procedures
      5. Cervical/ Lumbar Cellular Allografts
      6. Cervical/ Lumbar/ Thoracolumbar
      7. DBM Procedures
      8. Platelet-Rich Plasma
      9. Spine Growth Factors
      10. Thoracolumbar Spine Procedures
    • Spine Navigation
      1. Disposable/ Reusable/ Reposable Products
      2. Leased & Purchased
      3. Service & Maintenance
      4. Spine Navigation Procedures
      5. Spine Navigation Systems
    • Spine Surgery Assisted Robotics
      1. Disposable/ Reusable/ Reposable Products
      2. Leased & Purchased
      3. Robotic-Assisted Spine Surgery System
      4. Service & Maintenance
      5. Spine Robotics Procedures
    Stents
    • Neurovascular Stents
      1. Flow Diversion Stents
      2. Intrasaccular Stents
      3. Stent Procedures
      4. Traditional Neurovascular Stents
    Tissue Repair
    • Breast Reconstruction
      1. Allograft Breast Reconstruction
      2. Breast Reconstruction Procedures
      3. Synthetic Breast Reconstruction
      4. Xenograft Breast Reconstruction
    • Orthopedic Soft Tissue Repair
      1. Achilles Tendon Repair
      2. ACL/PCL Recon
      3. Biceps Tenodesis
      4. Hip Arthroscopy
      5. Meniscal Repair
      6. Orthopedic Soft Tissue Repair Procedures
      7. Rotator Cuff
      8. Shoulder Labrum
      9. Soft Tissue Repair Procedures
      10. Wrist Arthroscopy
    • Soft Tissue Repair
      1. Breast Reconstruction
      2. Cardiovascular Repair
      3. Dental Soft Tissue Regeneration
      4. Dural Repair
      5. Hernia Repair
      6. Nerve Repair
      7. Soft Tissue Repair Procedures
    • Wound & Tissue Management
      1. Collagen Dressings
      2. Mesh and Cyanoacrylate Skin Closure
      3. Skin Closure Strips
      4. Skin Substitutes
      5. Staplers
      6. Surgical Hemostat
      7. Tissue Sealant
    Urology
    • BPH (Benign Prostatic Hyperplasia)
      1. Bipolar Electrodes
      2. BPH Procedures
      3. Consumables/ Equipment
      4. Laser BPH
      5. Laser Enucleation Fiber
      6. Monopolar Electrodes
      7. Other Laser BPH Fiber
      8. Prostatic Stents
      9. PVP Laser Fiber
      10. Rezūm
      11. TUMT/ TUNA/ TURP
      12. UroLift
    • Erectile Dysfunction
      1. Erectile Dysfunction Procedures
      2. Inflatable Erectile Dysfunction Devices
      3. Malleable Erectile Dysfunction Devices
      4. Vacuum Erection Devices
    • Nephrostomy
      1. Nephrostomy Balloon Catheters
      2. Nephrostomy Drainage Tubes
      3. Nephrostomy Procedures
      4. Percutaneous Nephrostomy Sets
    • Prostate Cancer
      1. Afterloader Services
      2. Afterloader Systems
      3. Brachytherapy LDR/ HDR
      4. Brachytherapy Procedures
      5. Cryotherapy Ablation Procedures
      6. Cryotherapy Ablations
      7. LDR Seeds/ Needles
    • Stone Management
      1. ESWL Equipment
      2. ESWL Procedures
      3. Holmium Laser
      4. ISWL Equipment
      5. PCNL Procedures
      6. Stone Fragment Retrieval Devices
      7. Stone Management Procedures
      8. Transurethral Procedures
      9. Ureteral Stent
      10. Ureteral Stent Placement Procedures
    • Urinary Incontinence
      1. Bedside Urine Drainage Bags
      2. Female Incontinence Procedures
      3. Female Incontinence Sling
      4. Foley Catheters
      5. Intermittent Urinary Catheters
      6. Leg Urine Drainage Bags
      7. Male External Catheters
      8. Male Implantable Incontinence Devices
      9. Male Incontinence Procedures
      10. Urethral Bulking Agents
      11. Urinary Incontinence Procedures
    • Urodynamics
      1. Air-Charged Catheters
      2. Fiber Optic Catheters
      3. Hospitals/ Medical Offices
      4. Urodynamic Consumables
      5. Urodynamic Equipment
      6. Urodynamics Procedures
      7. Water-Filled Catheters
    • Urological Endoscopes
      1. Cystoscopes
      2. Nephroscopes
      3. New/ Refurbished
      4. Resectoscope
      5. Rigid/ Semi-rigid/ Flexible
      6. Single-Use Flexible Ureteroscopes
      7. Ureteroscopes
    Vascular Access
    • Catheter Securement
      1. Manufactured Catheter Securement Devices
      2. Securement by Catheter Type
      3. Sutures
      4. Tape and Dressings
    • Central Venous Catheters
      1. Acute CVC's
      2. Antimicrobial CVCs
      3. Chronic CVC's
      4. Coated Antimicrobial CVCs
      5. Conventional CVCs
      6. CVC Insertion Procedures
      7. Impregnated Antimicrobial CVCs
      8. Multi-Lumen CVCs
      9. Non-Power-Injectable CVCs
      10. Power-Injectable CVCs
      11. Single-Lumen CVCs
    • Dialysis Catheters
      1. Antimicrobial Dialysis Catheters
      2. Conventional Dialysis Catheters
      3. Hemodialysis Catheters
      4. Hemodialysis Procedures
      5. Non-Power-Injectable Hemodialysis Catheters
      6. Peritoneal Dialysis Catheters
      7. Peritoneal Dialysis Procedures
      8. Power-Injectable Hemodialysis Catheters
      9. Short Term/ Long Term Dialysis
      10. Step-Tip/ Split Tip Catheters
    • Implantable Ports
      1. Double-Lumen Implantable Ports
      2. Hybrid Implantable Ports
      3. Implantable Port Insertion Procedures
      4. Non-Power-Injectable Implantable Ports
      5. Non-Valved Implantable Ports
      6. Plastic Implantable Ports
      7. Power-Injectable Implantable Ports
      8. Single-Lumen Implantable Ports
      9. Titanium Implantable Ports
      10. Valved Implantable Ports
    • Midlines
      1. Long/ Short Midlines
      2. Midline Placement Procedures
      3. Non-Power-Injectable Midlines
      4. Power-Injectable Midlines
      5. Short AST/ MST Midlines
    • Other Vascular Access
      1. Antibacterial Catheter Patches
      2. Catheter Caps
      3. Extended Dwell Catheter Procedures
      4. Extended Dwell Catheters
      5. Vein Visualization Devices
      6. Vein Visualization Procedures
    • Peripheral Intravenous Catheters
      1. Acute/ Alternate Care
      2. Blood Control Safety PIVCs
      3. Conventional PIVCs
      4. Home Care PIVCs
      5. Non-Blood Control Safety PIVCs
      6. Outpatient & Nursing Home PIVCs
      7. PIVC Procedures
      8. Safety PIVCs
      9. Venous/ Arterial PIVCs
    • Peripherally Inserted Central Catheters
      1. Antimicrobial PICCs
      2. Basic PICC Kits
      3. Conventional PICVCs
      4. Double-Lumen PICCs
      5. Long Guidewire PICC Kits
      6. Non-Power-Injectable PICCs
      7. Non-Valved PICCs
      8. PICC Procedures
      9. Power-Injectable PICCs
      10. Single-Lumen PICCs
      11. Standard PICC Kits
      12. Tip-Placement PICC Kits
      13. Triple-Lumen PICCs
      14. Valved PICCs
    • Port Needles
      1. Acute/ Alternate Care
      2. Conventional/ Safety
      3. Non-Power-Injectable Port Needles
      4. Port Needle Insertion Procedures
      5. Power-Injectable Port Needles
    • Syringes and Needles
      1. Blunt Fill Needles
      2. Conventional Needles
      3. Conventional Syringes
      4. Hinged Safety Syringes
      5. Insulin Pen Needles
      6. Personal Insulin Syringes
      7. Pivoting Needles
      8. Professional Insulin Syringes
      9. Retractable Safety Syringes
      10. Safety Syringes
      11. Shielding Safety Needles
      12. Sliding Sleeve Safety Syringes
    • Tip-Placement Devices
      1. Disposable Tip-Placement Accessories
      2. Tip-Placement Procedures by Operator
      3. Tip-Placement Systems
    Video Hi-Tech
    • Surgical Booms
      1. Equipment Boom
      2. Hospitals/ ASCs
      3. Nursing Boom
      4. Utility Boom
    • Surgical Display & PACS Monitors
      1. 4K Surgical Displays
      2. 8-Megapixel UHD Surgical Displays
      3. ASC Surgical Displays
      4. HD Surgical Displays
      5. Hospital Surgical Displays
      6. PACS Monitor
    • Surgical Microscope
      1. Hospitals/ ASCs
      2. Neurosurgery Microscope
      3. Ophthalmology Microscopes
      4. Optometry Microscope
      5. Spine Microscopes
      6. Surgical Headlights
    • Surgical Tables
      1. General Surgical Table
      2. Hospitals/ ASCs
      3. Image-Guided Surgical Table
      4. Integrated Image-Guided Surgical Tables
      5. Neurosurgical Tables
      6. Non-Integrated Image-Guided Surgical Tables
      7. Orthopedic Surgical Table
      8. Spine Surgical Tables
      9. Standard/ Multi-functional
    Women's Health
    • Gynecology
      1. Assisted Reproduction Technology Devices
      2. Colposcope Market
      3. Fluid Management Devices
      4. Global Endometrial Ablation
      5. Gynecological Resection Devices
      6. Gynecology Procedures