Merit Medical Launches Bearing™ nsPVA (nonspherical polyvinyl alcohol)

We are pleased to introduce Bearing nsPVA Embolization Particles, the latest addition to Merit Medical’s broad array of interventional radiology embolization options.

bearingembopart

Merit Medical has been the market leader in spherical embolics (Embosphere® Microspheres) for over a decade and Bearing nsPVA will round out Merit’s embolization portfolio with an economical and nonspherical option. Merit’s established tradition for using state-of-the-art equipment and manufacturing processes has enabled us to develop this new product that offers enhancements over existing products in the current market.

Bearing nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters.

Bearing nsPVA is indicated for arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

We look forward to Bearing nsPVA leading the way to targeted embolization.

Noah Wong
Product Manager

Cath Lab Digest Article Shows How a Merit Medical Custom Fluid Management Set Up Can Help Reduce the Risk of Air Embolism

recent Cath Lab Digest article, “Proposal of Manifold Variation for Use During Cardiac Catheterization,” reported that a new manifold set up used in 1,500 diagnostic catheterizations was “safe, very easy and convenient to use.”

In the article, a custom Merit Medical Fluid Management Kit was pictured showing a modified construction that allows physicians to inject medication while keeping the system closed during angiography, thus reducing the risk of air embolism associated with syringe exchanges.

HowardFigure1
Photo of Merit Medical fluid management products in the configuration suggested in the article.

By inserting a 3-way stopcock with pigtail attached to a 5 mL syringe on the heparin flush line, the operator can inject medication through the heparin flush line into the arterial circulation without exchanging the syringe from the manifold.

Click on the following link to watch our Fluid Management System & Custom Designed Kits video. To find out how to get this custom fluid management kit, contact a Merit Medical Representative today!

Mark Heninger
Senior Product Manager

Merit Medical Receives CE Mark for HepaSphere™ Microspheres 30-60 Micron Size

I am pleased to share that we have received the CE Mark for HepaSphere Microspheres’ newly developed 30-60 micron size. The new smaller size provides physicians with the ability to achieve more distal occlusions when embolizing hypervascular tumors and arteriovenous malformations. When packaged in their dry state, the new size microspheres measure 30-60 microns, but when reconstituted for use, they expand to 120-240 microns.

Hepashpere

HepaSphere Microspheres are biocompatible, hydrophilic, non-resorbable, and conformable microspheres designed for controlled, targeted embolization. HepaSphere Microspheres also rapidly absorb aqueous solutions such as contrast media, saline, or doxorubicin HCI. HepaSphere Microspheres 30-60 micron size, along with the currently available sizes, further enable physicians to optimize outcomes by more precisely matching the sphere size to the size of the targeted vasculature.
I am delighted to bring this new smaller size to the market together with a broad line of Interventional Radiology implant options designed to help physicians offer the best possible patient care.

Jim Kelly
Senior Director of Marketing, Merit Medical

HepaSphere Microspheres are not approved or available for sale in the United States.

Radiofrequency-targeted vertebral augmentation for the treatment of vertebral compression fractures as a result of multiple myeloma.

Erdem E, Akdol S, Amole A, Fryar K, Eberle RW. Spine 2013. Pubmed ID: 23591655

STUDY DESIGN: A retrospective review of a consecutive population of patients treated with radiofrequency-targeted vertebral augmentation (RF-TVA) for malignant vertebral compression fractures (VCFs). To investigate the safety and efficacy of RF-TVA in patients with malignant VCFs.

SUMMARY OF BACKGROUND DATA: The use of polymethylmethacrylate (PMMA) in vertebroplasty and balloon kyphoplasty for patients with recalcitrant pain after acute VCFs is shown to be safe, successful in stabilizing the VCF, and effective for the relief of pain after osteoporotic and malignant VCFs. RF-TVA using targeted cavity creation and ultrahigh viscosity PMMA delivery with a long handling time was developed to address the potential adverse issues that arise with vertebroplasty and balloon kyphoplasty.

METHODS: Between December 2008 and May 2009, a consecutive series of 66 RF-TVA procedures were performed for VCF secondary to multiple myeloma. Pre- and postoperatively, a standard 10-point visual analogue scale was used to assess back pain. Pain medication use and activity categories were defined and monitored for changes before and after RF-TVA. All patients were followed for 6 months postoperatively.

RESULTS: At 6 months postoperatively, significant improvement in pain, activity, and narcotic use was observed. Overall change in pain VAS score was statistically significant at 6 months (p< 0.001) and 75% of patients had a 6-month VAS of less than 4.There were no pulmonary or neurological complications, and one patient had radiographic evidence of asymptomatic leakage of PMMA into the vertebral disc space.

CONCLUSION: Optimum safety and efficacy results in the treatment of malignant VCFs with a novel RF-TVA technique in which controlled delivery of an ultrahigh viscosity PMMA is used for fracture stabilization. The deposition of PMMA with RF-TVA is predictable and uniform, and can be performed without PMMA handling constraints that may be encountered with vertebroplasty and balloon kyphoplasty.