Closure System Permanently Seals Varicose Veins 
|
By HospiMedica International staff writers Posted on 01 Mar 2015 |
|
Image: The VenaSeal Closure System (Photo courtesy of Sapheon).
A novel embolic system uses an adhesive agent that polymerizes inside superficial varicose veins of the legs, sealing them shut.
The VenaSeal Closure System is composed of a specially formulated adhesive (n-butyl-2-cyanoacrylate) and a delivery system that includes a catheter, guidewire, dispenser gun, dispenser tips, and syringes. The VenaSeal Closure System does not require tumescent anesthesia to be injected peripherally into the leg, and because there are no pre-procedures drugs involved, patients can usually return to their normal activities right after the treatment, with just a Band-Aid in place.
For example, to seal the great saphenous vein (GSV), the catheter is first guided via ultrasound (US) towards the saphenofemoral junction (SFJ); once properly placed near the SFJ, the adhesive is injected into the lumen, sealing the vein. The procedure is then repeated every three cm along the GSV. Once closed, blood is immediately rerouted through other healthy veins in the leg. The VenaSeal Closure system is a product of Sapheon (Morrisville, NC, USA), a part of Covidien (Dublin, Ireland), and has been approved by the US Food and Drug Administration (FDA).
“Cyanoacrylate embolization is an effective and durable solution to the problem of incompetent great saphenous veins; long-term effectiveness is high,” said Prof. Thomas Proebstle, MD, of Mainz University (Germany), who led the European multicenter clinical study of the system. “The elimination of the need for perivenous tumescent anesthesia and post-interventional compression stockings, along with the associated side effects, results in significantly improved treatment.”
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, MD, MPH, acting director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health (CDRH). “Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.”
Varicose veins (also known as venous reflux disease) occur when valves inside the veins break and blood is unable to circulate properly. This is a common condition that affects both men (25%) and women (40%). Varicose veins can occur anywhere from the groin to the ankle.
Related Links:
Sapheon
Covidien
The VenaSeal Closure System is composed of a specially formulated adhesive (n-butyl-2-cyanoacrylate) and a delivery system that includes a catheter, guidewire, dispenser gun, dispenser tips, and syringes. The VenaSeal Closure System does not require tumescent anesthesia to be injected peripherally into the leg, and because there are no pre-procedures drugs involved, patients can usually return to their normal activities right after the treatment, with just a Band-Aid in place.
For example, to seal the great saphenous vein (GSV), the catheter is first guided via ultrasound (US) towards the saphenofemoral junction (SFJ); once properly placed near the SFJ, the adhesive is injected into the lumen, sealing the vein. The procedure is then repeated every three cm along the GSV. Once closed, blood is immediately rerouted through other healthy veins in the leg. The VenaSeal Closure system is a product of Sapheon (Morrisville, NC, USA), a part of Covidien (Dublin, Ireland), and has been approved by the US Food and Drug Administration (FDA).
“Cyanoacrylate embolization is an effective and durable solution to the problem of incompetent great saphenous veins; long-term effectiveness is high,” said Prof. Thomas Proebstle, MD, of Mainz University (Germany), who led the European multicenter clinical study of the system. “The elimination of the need for perivenous tumescent anesthesia and post-interventional compression stockings, along with the associated side effects, results in significantly improved treatment.”
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, MD, MPH, acting director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health (CDRH). “Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.”
Varicose veins (also known as venous reflux disease) occur when valves inside the veins break and blood is unable to circulate properly. This is a common condition that affects both men (25%) and women (40%). Varicose veins can occur anywhere from the groin to the ankle.
Related Links:
Sapheon
Covidien
Gold Member
Blood Gas Analyzer
i-Check200
Syringe Pump
SP50 Series
Surgical System
Stealth AXiS
Latest Surgical Techniques News
- Researchers Develop Microbots to Help Drugs Reach Blood Clots
- Minimally Invasive Balloon Procedure May Redirect Blood Flow During
- First Stemless Reverse Shoulder Arthroplasty System Receives FDA Clearance in U.S.
- First U.S. Procedures Successfully Completed With New GERD Implant
- Study Explores 4DCT Ventilation for Preoperative Assessment in Early Lung Cancer
- Dual-Technique Approach Improves Stent Expansion in Calcified Coronary Lesions
- FDA Approves First Transcatheter Device for Paravalvular Leak Closure
- Smaller Surgical Margins May Help Protect Healthy Tissue in Young Sarcoma Patients
- BD Launches TIPS Stent Graft for Personalized Portal Hypertension Treatment
- Implantable Ultrasound Device Enhances Local Drug Delivery in Glioblastoma
- FDA-Cleared Thrombectomy System Removes Pulmonary Embolism Clots
- Miniature Image Sensor Enables Digital Imaging in Single-Use Endoscopes
- Transcatheter Repair System Gains FDA Approval for Severe Tricuspid Regurgitation
- Half-Matched Family Donors Could Expand Transplant Access for Severe Aplastic Anemia
- Dual-Imaging Catheter Completes Initial Human Evaluation of Coronary Plaque
- Shape-Changing Hydrogels Show Promise for Tissue Engineering and Wound Healing
Channels
Artificial Intelligence
view channel
AI Analysis of Smartwatch ECGs May Help Detect Weakened Heart Function
Left ventricular systolic dysfunction (LVSD) occurs when the heart’s main pumping chamber does not contract effectively. The condition can remain asymptomatic for some time but may progress to symptomatic... Read more
AI Tool Speeds Echocardiogram Reporting With Comparable Accuracy
Echocardiography is the most widely used form of cardiac imaging, playing a key role in diagnosing heart disease and guiding treatment decisions. However, reviewing ultrasound images and documenting cardiac... Read more
Critical Care
view channel
Miniature Wearable Sensor Enables Continuous Cuffless Blood Pressure Monitoring
Blood pressure is a key indicator of cardiovascular health, but conventional cuff-based measurement typically provides only a single reading at one point in time. This can limit monitoring during everyday... Read more
Studies Support AI-ECG for Detecting Suspected Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy is frequently underdiagnosed despite being an important cause of cardiac morbidity. Routine 12-lead electrocardiograms are widely available in emergency, inpatient, and perioperative... Read more
Patient Care
view channel
Virtual Reality Program May Reduce Anxiety Before Pediatric Surgery
Presurgery anxiety affects an estimated 50% to 75% of children undergoing surgery and can complicate anesthesia induction, increase postoperative pain, and prolong recovery. Sedation is often used to manage... Read more
Video-Based Support Helps Older Adults Clarify Kidney Disease Treatment Preferences
Advanced chronic kidney disease (CKD) involves progressive loss of kidney function that can lead to kidney failure and difficult treatment decisions. For older adults, these decisions may include choosing... Read more
Medical Imaging
view channel
MRI-Guided Focused Ultrasound Improves Motor Symptoms in Parkinson’s Disease
Parkinson’s disease is a progressive neurological disorder that can cause tremor, muscle stiffness, slowed movement and medication-related involuntary movements. These symptoms can limit daily function... Read more
AI Tool Reconstructs Missing Brain Connectivity Data
Diffusion MRI helps map nerve fiber pathways in the brain, but some scans lose signal in regions that are important for understanding connectivity. These gaps can affect areas such as the brainstem and... Read more
Health IT
view channel
Clinical Decision Support Tool Automates CKD Risk Assessment in Primary Care
Chronic kidney disease (CKD) requires timely diagnosis, risk assessment, and coordinated treatment in primary care. Delayed recognition can affect decisions about testing, blood pressure control, cardiovascular... Read more
EHR Alerts Support Dosing, Sedation, and Shock Recognition in Cardiac Care
Electronic health record alerts can add to clinician workload when they are poorly targeted. In critical cardiac care, however, delayed decisions can affect treatment timing, sedation exposure, and escalation... Read more
Point of Care
view channel
New Breath Condensate Testing Approach Enhances Reliability for COPD Monitoring
Chronic obstructive pulmonary disease (COPD) is a progressive lung condition that can increasingly impair breathing over time. Diagnosis and monitoring may be burdensome because patients often require... Read more
Continuous Glucose Monitoring Identifies Cardiometabolic Risk in Adults Without Diabetes
Dysglycemia—abnormal blood glucose regulation—can fluctuate throughout the day and often escape conventional screening. Clinicians typically rely on fasting plasma glucose and hemoglobin A1c, which offer... Read more
Business
view channel
Stryker Completes Acquisition to Broaden Shoulder Surgery Offerings
Stryker (Portage, MI, USA) has completed its acquisition of ZuriMED (Zurich, Switzerland), a privately held developer of the FiberLocker System, expanding its Sports Medicine portfolio with a commercialized... Read more
