ClariVein OC - treatment for endovenous mechanochemical ablation

ClariVein® OC 5-Year Follow-up Results: Good Occlusion Rate, No Major Complications

Chronic venous insufficiency (CVI) in the legs, also known as varicose veins, is a relatively common condition, with worldwide prevalence ranging between 10% and 30%. Varicose veins can result in a number of symptoms, including pain, leg swelling, itching, and skin discoloration. Individuals with the condition may experience diminished quality of life and loss of work productivity. Finding treatment options that are effective and comfortable for the patient have been an area of interest in the endovascular community. ClariVein OC - treatment for endovenous mechanochemical ablation

A study by researchers in Verona, Italy, found that endovenous mechanochemical ablation (MOCA) treatment with the ClariVein® OC Infusion Catheter was associated with a good occlusion rate, comparable with other techniques, including thermal techniques, without major complications. This is one of the first reports in literature for MOCA treatment of symptomatic varicose veins with 5-year results. With little long-term data pertaining to this type of treatment, the aim of the study was to evaluate long-term occlusion rates.

This retrospective single-center study was published in Journal of Vascular Surgery: Venous and Lymphatic Disorders. Mirandola et al. treated 395 primary, symptomatic, unilateral, incompetent varicose saphenous veins in an outpatient setting. Of these patients, none were treated bilaterally in the same session. The majority of vessels treated were great saphenous veins (92.3%), and the others were small saphenous veins. Procedures were performed with the ClariVein OC and polidocanol 2% in liquid form.

A total of 329 patients were available for follow up, each treated between September 2012 and September 2017. Average follow-up time was 20 ± 18 months (range, 6-60 months). Results showed a technical success of 99.5%. Treatment was incomplete in two patients due to vein spasm, leading to catheter damage and inability to infuse the sclerosant. Follow up consisted of clinical evaluation and duplex ultrasound scan performed at 1 week, 1 month, 6 months, 1 year, and then once every year.

The overall survival rate free from recanalization was 92.4%. Anatomic success was 94% at 1 year, 91% at 2 years, 88% at 3 years, 88% at 4 years, and 84% at 5 years. The follow up at 5 years included 23 patients, five of whom presented with recanalization. The authors note that in this series, the veins completely disappeared on duplex ultrasound scan in 36% of cases.

It is interesting to note that after 89 patients, the researchers changed the way in which the sclerosant was injected. Beginning the infusion of sclerosant at point of mechanical pullback (protocol 2) produced higher occlusion rates compared to traditional ClariVein OC technique (protocol 1) with delayed infusion of sclerosant. Protocol 2 resulted in a change in cumulative survival rate free from recanalization from 92% to 97% (P ¼ 0.013).

Difference in anatomic success between 2 different protocolsFig 4. Difference in anatomic success between the two different protocols.

The researchers concluded that the ClariVein OC was associated with a good occlusion rate and was comparable with other techniques, including thermal techniques, without major complications.

Varicose veins occur when vessels are unable to pump blood back to the heart, causing the blood to pool, resulting in vessel enlargement over time. Under normal conditions, blood moves from the heart to the legs through the arteries and back to the heart through the veins. To accomplish this, the veins rely on surrounding muscles and a collection of valves to prevent blood from flowing backward. When these muscles and valves weaken or fail to work, blood begins to gather in the vein instead of returning to the heart.

In addition to pain, swelling, itching, and skin discoloration, other symptoms of varicose veins include:

  • Twisted and bulging veins
  • Aching, burning, throbbing and muscle cramping
  • Leg heaviness and fatigue

The ClariVein OC alleviates these symptoms by combining the power of a specialty infusion catheter with a rotating wire tip designed for the controlled 360-degree dispersion of physician-specified agents inside the targeted vessel. Requiring only a pin-sized entry through the skin, treatment with the ClariVein OC takes very little time, uses no heat or tumescent anesthesia, and creates minimal discomfort to the patient.

Learn more about the clinically proven ClariVein OC and how it can change the lives of your patients. Visit ClariVein.com or contact our Customer Support for more information.


IMPORTANT: This product page is intended only for an audience outside of the United States, as ClariVein OC is not approved, cleared, or available for sale in the United States. This product is not approved, cleared, or available for sale or use in the United States, and may not be approved, cleared, or available for sale or use in other countries. Please check with your country representative to determine which ClariVein catheters are available in your country. Please consult the product Instructions for Use (IFU) for indications, contraindications, potential complications, warnings, precautions, and directions for use.

ARTICLE REFERENCED:

Mirandola M et al. 2020. “An Italian Experience with Mechanochemical Ablation of the Saphenous Vein Since 2012.” J Vasc Surg Venous Lymphat Disord 8, no 6 (Nov): 999–1005. PMID: 32179039.

One-Vac Evacuated Drainage Bottle - Merit Medical

Meet the One-Vac™, Merit’s Newest Evacuated Drainage Bottle

One-Vac Evacuated Drainage Bottle - Merit MedicalMerit Medical is proud to announce the launch of the One-Vac Evacuated Drainage Bottle, the latest in evacuated drainage bottle technology. The smart option to aspirate, remove, or sample percutaneous fluids, the One-Vac is engineered with an advanced design that makes collection and discard simple, efficient, and safe.

The One-Vac is a valued addition to Merit’s Drainage portfolio and accompanies other premier products, such as the Aspira® Drainage System. This extension of the Drainage portfolio is the result of Merit’s commitment to continued innovation and dedication to providing clinicians with multiple high-quality product options when treating patients.

Read the press release.

Several key features are designed to make the One-Vac easy to use, helping to reduce the occurrence of common issues associated with bottle use. 

 

One-Vac Bottle has a number of design features that will provide lasting benefits to you and your patients

KEY FEATURES & BENEFITS

1 – Ergonomic Handle
Start, stop, and regulate flow. Easy to remove, minimizing spills during discard.

2 – Easy Sampling
Connect syringe and open handle to remove fluid for sampling.

3 – Bottle Neck
Easy to hold.

4 – Durable Plastic
Designed to prevent breakage.

5 – Faster Flow Rates
Provides 68% faster flow rates than competitive evacuated bottles.1

 

Learn more about the One-Vac Evacuated Drainage Bottle by exploring its product page or by connecting with our Customer Support Center to see how you can incorporate it and other Merit solutions into your practice today.


Before using, refer to the product Instructions for Use (IFU) for indications, contraindications, potential complications, warnings, precautions, and directions for use.

REFERENCES

1. Data on file.

SCOUT Radar Localization - Expanding to Europe, Middle East and Africa

A Physician’s Perspective on Wire-Free Localization

Everett Bonner MD - SCOUT Physician

INTRODUCTION

Everett Bonner, MD, is a general surgeon specializing in surgical breast oncology at the Baton Rouge Clinic a large, multi-specialty clinic in Baton Rouge, LA. Dr. Bonner joined the group after completing his Surgical Breast Oncology Fellowship at Memorial Sloan-Kettering Cancer Center, New York, NY.

Dr. Bonner performs on average 25-30 breast surgical procedures a month at Baton Rouge General Hospital, which implemented their wire-free program with SCOUT in 2019. Dr. Bonner led the SCOUT implementation and shares his perspectives.

What was your primary motivator in evaluating and switching to a wire-free technology?

I think the biggest motivating factor was the problems we had with wire localization. Let’s be honest, no one likes them, not the physicians and certainly not the patients. Wires were becoming dislodged; patients were a bit “freaked out” about a 10-inch wire hanging out of their breast covered by a paper cup.

I always thought sterilization was an issue. We are always so conscious of this in the OR, yet we have this 10-inch wire that was exposed to all kinds of elements for a few hours. I say that a localization with SCOUT facilitates a more sterile surgery.

I also perform Hidden Scar Surgery, and a wire localization made it very difficult for me to place the incision exactly where I wanted. Utilizing the SCOUT technology has eliminated that issue. I have total freedom to place my incision where the patient will not see it and have a constant reminder of her cancer. In a lot of my cases, I can make one hidden incision under the arm for the tumor and the sentinel node.

It has revolutionized my practice – it has been a game changer.

Were you familiar with other wire-free technologies?

SCOUT Radar Localization - Expanding to Europe, Middle East and Africa

We did not trial SCOUT first. We trialed two other wire-free options, and we were not very happy. With one we had to continuously adjust equipment, and with the other we would have needed to switch to a whole new standard of surgical instruments.

For us, SCOUT was the technology of choice. It was more user friendly, and we would not have to rebuy all new instrumentation. It has worked out extremely well for the hospital, for our practice, and we have never looked back. In fact, my associates and I now almost localize exclusively with SCOUT, and most of us have not used a wire localization in more than a year.

Since using SCOUT, how has it affected your surgical outcomes?

It has been a game changer in three key areas. First and foremost, my re-excision rate is down to less than 5% (the national average is about 10%). I spend less time in the OR, and infection rates have dropped.

I think a very important point is that I use SCOUT, not only for localization, but for real-time guidance during surgery. I am constantly using SCOUT as I am doing my circumferential dissection around the tumor. I am constantly relocating to make sure I am not too close to the tumor, and once I have removed the tumor, I do a margin assessment circumferentially. If it looks like I am too close into a particular margin, I will go back and take additional tissue.

Also, not to be minimized is the fact that I can perform a lumpectomy in about 30 – 45 minutes, as opposed to the hour and a half it normally takes with a wire localization. That is less OR time, less anesthesia for the patient, which all adds up to safety and cost savings.

What can you tell us from a patient’s perspective about a wire-free experience?

Patients love it! I do a lot of patient education upfront, and I am very detailed in explaining the whole surgical experience. I get rave reviews on how “cool” SCOUT, is and they love that they cannot see or feel it, especially patients who have had a past wire localization experience.

At first, I did get a bit of push back about making a trip to the hospital to get the reflector placed, but once I explain that it can be done in conjunction with pre-admission testing, that concern was alleviated.

Patients really appreciate the value of new technology. It is good for them and good for the practice. Being on the forefront of new technology has improved my patient volume. We do little advertising. Therefore, its popularity has been purely by word of mouth.

What are the main outcomes a physician should expect from their wire-free technology?

The number one thing is cleaner margins and the potential to decrease your re-excision rate. Like I mentioned before, my rate is now half of what it was with a wire.

Number two is patient comfort and satisfaction. Patients are nervous enough going to surgery. Add the discomfort and the trauma of a wire sticking out of their breast and that is not patient centric. SCOUT has changed all of that.

The third one, and I think also a major consideration, is precision. You can take less tissue because you know exactly where you are going as you dissect the tumor, which results in a more cosmetically appealing result. Some surgeons say, “Just take a larger tissue sample.” But my question is why when SCOUT is so precise? With this localization and guidance technology, you can take less tissue and have good margins as well as a better cosmetic outcome.


This information is for the practitioner’s convenience and for general information purposes only. This information does not constitute medical or legal advice, nor is it meant to endorse or guarantee the suitability of any of the referenced products or methods for any specific patient or procedure. Before using any product, refer to the Instructions for Use (IFU) for indications, contraindications, warnings, precautions, and directions for use.
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