Klass Doxorubicin Dose Escalation Study Examines Dose & Delivery for the Treatment of HCC

The purpose of Dr. Darren Klass, et al’s study — “The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatocellular carcinoma: a dose escalation study” — was to investigate “the relationships between dose and delivery parameters as they pertain to toxicity and response in surgically resectable hepatocellular carcinoma (HCC).”1  The study included 25 patients, randomly assigned and divided into 4 subgroups each receiving bland, 25 mg, 50 mg, 75 mg of doxorubicin-loaded HepaSphere™ Microspheres.

Klass and his colleagues published the following results:

  • 56% of patients demonstrated complete response according to EASL criteria as opposed to 0% according to RECIST (v1.0) criteria.
  • Residual tumor was identified in all groups (0 mg: 35%±28.5%; 25 mg: 42%±30.4%; 50 mg: 3.6%±3.3%; and 75 mg: 49.29%±32.6%).
  • No difference was noted between bland embolic and drug-loaded groups. Subset analysis did demonstrate a significantly increased degree of necrosis in the 50 mg-loaded group (p=0.018).
  • Strong correlation existed between arterial phase Computer Tomography EASL-based response and histopathology (r=0.81; p<0.0001).

The study concluded that “Histology correlates strongly with one-month post-procedural imaging and response optimized at 50 mg of loading per vial. Adverse events were a reflection of embolization, with no relationship between loading dose or administered dose of doxorubicin.”

Merit Medical’s HepaSphere Microspheres are indicated for use in embolization of blood vessels with or without delivery of doxorubicin HCI for therapeutic or preoperative for the embolization of hepatocellular carcinoma and embolization of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

HepaSphere Microspheres offer targeted embolization that is flow directed due to their spherical shape, they rapidly absorb aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI,* and compress in the vessel lumen, providing more surface contact with vessel intima. HepaSpheres expand up to four times the stated dry diameter when hydrated. For more information on HepaSphere Microspheres, go to the HepaSphere product page or contact us.

Antonio Rivera
Senior Product Manager

 

1 Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Research. 2014 Jul;34(7):3597-3606.

HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.

 

ONE Snare® Microsnare Sizes Approved for Sale in Europe

Merit Medical’s ONE Snare microsnare sizes are CE marked and available for sale in Europe. These new ONE Snare product configurations are available in loop diameters of 2 mm, 4 mm and 7 mm, with a 2.3F — 3F snare delivery catheter.

The ONE Snare suite of endovascular snares are now available in 15 kit configurations with 10 loop diameters ranging from 2 mm to 35 mm. These sizes complete the suite of ONE Snare product configurations and give physicians additional choices and options when foreign body manipulation or retrieval procedures arise. Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare® Endovascular Snare Systems go hand-in-hand to provide physicians with both single-loop and triple-loop options to help meet any clinically-challenging case that may arise, because having options matters.

To learn more, visit the ONE Snare product webpage.

Merit Medical Showcases Products for Lead Implantation

I’ve just returned from the XVI International Symposium on Progress in Clinical Pacing that was held in Rome, Italy. The symposium was a big success. Merit Medical was a sponsor of this meeting dedicated to the treatment of cardiac arrhythmias where innovation and new diagnostic and therapeutic techniques are discussed. Dr. Seth J. Worley of Lancaster, Pennsylvania was one of the Course Directors of a half-day symposium on Interventional Device Implantation that was conducted over three sessions with Dr. Buongiorni from Pisa, Italy and Dr. Torkel Steen from Oslo, Norway as co-chairs. Some of the topics discussed were:

  • How to Cross a Subclavian Occlusion for Venous Access
  • Snares for LV Lead Implantation: the most powerful technique for difficult LV lead insertion that often replaces venoplasty and anchor balloons
  • Interventional vs. Traditional Approach to Device Implantation

Dr. Worley is the inventor of Merit’s Worley™ LV Delivery System. This telescoping system provides the options and tools needed to overcome the challenges of complex LV lead location and to help deliver leads, even in difficult cases. Clinical evidence has shown that a telescoping support catheter system can reduce implantation times, provide easier access to the target vessel, and improve chances for successful CRT implantation.1

To learn more about Merit’s products for CRT implantation, click on the links below:

Worley Coronary Sinus Guide

Worley Lateral Vein Introducer

Worley Vein Selector

Sincerely,

Matt Toone, Merit Medical Marketing Director, EP

Pacing symposium in Rome Worley Workshop