First Patients Enrolled in the STARRT Clinical Study

DFINE® Announces First Patients Enrolled in the STARRT Clinical Study on Spinal Tumor Ablation with the STAR Tumor Ablation System

Prospective multi-center trial enrolling patients in USA

San Jose, Calif. January 23, 2015 — DFINE, Inc.,announced today that the first two patients have been enrolled in the STARRT Clinical Trial at Providence Sacred Heart Medical Center, Spokane WA. The multi-center trial is the first prospective study to evaluate the treatment of painful metastatic lesions with STAR Targeted Radiofrequency Ablation (t-RFA) and Radiofrequency Targeted Vertebral Augmentation (RF-TVA) prior to or following radiation therapy.

The principal investigator for the study, Jack Jennings, M.D., Ph.D., Director of Spine and Musculoskeletal Intervention at Washington University School of Medicine (St. Louis, MO), commented, “The protocol for this study is designed to clarify t-RFA as part of the treatment algorithm for metastatic spinal tumors and is the result of the collaboration of a multi-disciplinary working group on metastatic spine disease.”

DFINE will enroll 64 patients presenting with painful metastatic spinal lesions at up to 20 centers in the United States. The trial will evaluate the degree and durability of the palliative effect of t-RFA and vertebral augmentation combined therapy. Patients that have either failed or refuse further radiation therapy, or have yet to receive radiation therapy are eligible to be enrolled. Patients will be evaluated through a six month follow up period. The primary outcome is reduction of their pain. Secondary outcomes being evaluated are changes in quality of life, reduction of pain medications and the time to achieve adequate pain relief. Tumor control will also be evaluated.

“We’ve had very promising results with targeted radiofrequency ablation (t-RFA) to ablate localized metastatic spine tumors and augment the fractured vertebrae that is often associated with the disease. This procedure allows me to give patients rapid pain relief that dramatically improves their quality of life,” said Dr. Jayson Brower, the principal investigator at Providence Sacred Heart Medical Center where the first two patients were treated.

Cancer is a major public health problem throughout the world, and when cancer is not found early, it can metastasize (spread) to other parts of the body. A metastatic spinal tumor is a growth of cells (mass) in or around the vertebra of the spine. Over five million Americans are living with cancer that was diagnosed in the last five years and more than 1.67 million new cancer cases were expected to be diagnosed in the US in 2014 1 It is estimated that 30-40% of late-stage cancer patients will likely develop metastatic spinal tumors.2

“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of metastatic spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE.

“As a company, we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in the United States on this landmark trial.”

To learn more about the STARRT clinical trial, go to Clinical trials.gov/ study ID # NCT02225223.

STAR™ Tumor Ablation System

Indications for Use

The STAR Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Risks & Contraindications

Like all surgical procedures, radiofrequency ablation procedures using the STAR System involve risks, and some patients are not good candidates for the procedure. For detailed description of risks and contraindications, please review the product Instructions for Use.

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.

 

Merit Medical To Exhibit Dialysis Product Line at American Society of Diagnostic and Interventional Nephrology (ASDIN) in Orlando, February 13-15, 2015

Merit Medical is exhibiting at the 11th Annual Scientific Meeting of the American Society of Diagnostic and Interventional Nephrology in Orlando, Florida to introduce attendees to its expanding line of Hemodialysis and Peritoneal Dialysis products. The Merit Medical dialysis product suite includes the following key products:

  • The CentrosFLO® Hemodialysis Catheter, invented by Dr. Stephen Ash, was shown in a recent retrospective study to have statistically greater patency after three months due to its self-centering, curved-tip catheter which is designed to reduce thrombosis and fibrin sheath formation.1
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  • The ProGuide™ Hemodialysis Catheter has a step-tip with an appositional bump design intended to reduce arterial insufficiency by keeping the tip of the catheter from sucking up against the vessel wall. The ProGuide is well known as an exchange catheter due to its easy, over the wire placement capability.
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  • The Flex-Neck® line of Peritoneal Dialysis Catheters allow for up to 35% higher flow rates than other catheters currently on the US market. The Flex-Neck Classic and ARC shapes are designed to accommodate various tunneling techniques and exit site options. Our unique Implantation Systems are designed to streamline your specific implantation technique.
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  • The Merit Percutaneous Implantation Kit for peritoneal dialysis (PD) catheter placement is designed to accommodate stylet or over-the-wire placement using ultrasound-guided access and fluoroscopy. To see how the kit is used, watch the PD Percutaneous Implantation Video.

Visit Merit Medical at Booth 207 to learn more about this broad line of products designed to enhance the practice of dialysis interventions and catheter placements.

Nathan Smith
Senior Product Manager
 Lynette Ruppel
Senior Product Manager

1Data on file

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.