Merit Medical’s ConcierGE® Guiding Catheter Now Available in Radial-Specific Shapes

Minimizing the number of catheter exchanges is important for transradial interventions in order to reduce the likelihood of spasm.1 Using catheters with radial-specific shapes may help radial operators minimize the number of catheter exchanges that can result in spasm.1

To meet the needs of radial diagnostic and interventional procedures, Merit Medical now offers the Ultimate 1 shape in both diagnostic catheters and ConcierGE® Guiding Excellence catheters with radial-specific shapes.

ConcierGE has approximately 30% more kink resistance2 and better torque response3 than the leading guiding catheter brands.

Cardiologists will now have the ability to match their guiding catheter to the shape of their diagnostic catheters, helping to reduce the need for multiple catheter exchanges.

Merit’s Performa Ultimate™ diagnostic cardiology catheters include four radial–specific shapes including the Ultimate shape, which can be used in both right and left coronary arteries using a single catheter.

ConcierGE and Performa Ultimate–more shapes give radialists more options for successful access.

Guido Sanduilli
Marketing Director
Cardiovascular Division

1 Kwan et al, http://www.ptca.org/radial/optitorque_kwan.html
2 Data on File. Test results are based on 6F guide catheter comparison.
3 Data on file. At ½ hub rotation.

InQwire® Diagnostic Guide Wire Available in Baby J Configuration To Facilitate Transradial Intervention

Manipulating diagnostic guide wires through radial vasculature can sometimes be a little more complex than the pathways used during femoral access. To help facilitate radial navigation, Merit offers its InQwire diagnostic guide wire in both the standard J 3.0 mm curved tip as well as a 1.5 mm smaller ”baby” J tip configuration. The smaller, more closed J tip can help you navigate through the vasculature without selecting unwanted branches along the pathway.

The InQwire guide wire is precoated over the entire wire surface for smooth, consistent coverage that resists flaking. Smooth PTFE coating means less friction which improves trackability, lubricity, and durability. InQwire wires also have precise J-tip memory that ensures tip shape retention during utilization.

Catalog Code
Diameter
J Tip
Length
Configuration
IQ35F210J1O5
0.035″
(0.89 mm)
1.5 mm
210 cm
Standard
IQ35F210J1O5F
0.035″
(0.89 mm)
1.5 mm
210 cm
Firm
IQ35F210J3
0.035″
(0.89 mm)
3.0 mm
210 cm
Standard
IQ35F220J3
0.035″
(0.89 mm)
3.0 mm
220 cm
Standard
IQ35F260J1O5
0.035″
(0.89 mm)
1.5 mm
260 cm
Standard,
Exchange
IQ35F260J1O5F
0.035″
(0.89 mm)
1.5 mm
260 cm
Firm
Exchange
IQ35F260J3
0.035″
(0.89 mm)
3.0 mm
260 cm
Standard
Exchange

Having the right tools for your radial procedure provides the efficiency and effectiveness that can help ensure a successful outcome for your patients. Contact your local Merit Sales Representative to learn more about InQwire for radial and our extensive line of products for radial approach.

Penny Goldman
Senior Product Manager

Merit Offers Radial Internal Mammary Catheter for Navigating LIMA Grafts

Transradial cardiac catheterization in patients with previous coronary artery bypass graft surgery can be technically challenging.

Since the majority of CABG patients have a left internal mammary artery (LIMA) graft to the left anterior descending artery (LAD), many radial operators choose to perform catheterization procedures in CABG patients from a left radial approach using standard femoral diagnostic catheters. However, other operators have reported success with the right radial access to the LIMA. Right radial access for right radial LIMA angiography provides more comfortable access from the right side of the patient, reduces back strain, and the need to reach over the patient, especially patients who are obese.

For patients with LIMA grafts, Merit Medical now offers a Radial Internal Mammary catheter to facilitate navigation to the left internal mammary from the right transradial approach. The Merit Radial Internal Mammary catheter is available in 4F and 5F, 110 cm lengths. The Impress® material offers a highly torqueable shaft with a soft, tapered atraumatic tip.

Combining Merit’s broad offering of products for radial approach with your clinical expertise can help achieve the improved outcomes you expect from the radial approach including reduced complications, quicker ambulation, and increased patient comfort.

For more information about the Impress Radial Internal Mammary catheter and Merit’s growing portfolio of products for your radial procedures, visit the product page on merit.com.

Tami Anderson
Senior Product Manager

Malagari Safety and Efficacy Study of HCC TACE with HepaSphere™ Microspheres 30-60µm

Malagari photo of doc

Dr. Katerina Malagari et al conducted a study of 45 patients with hepatocellular carcinoma (HCC) treated with the new 30-60 µm size HepaSphere Microspheres. The study found that “TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality.”1 The overall objective response from the study was “(CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9% of cases.”1 The results were published in Cardiovascular Interventional Radiology in February 2014.

HepaSphere 30–60 µm is a new size of a loadable microsphere that has a dry caliber of 30–60 µm that expands to 166–242 (197 ± 31) µm in saline and 145–213 (148 ± 45) µm after loading with doxorubicin. HepaSphere Microspheres’ unique properties offer the following advantages:

Targeted:       Flow directed due to spherical shape.

Absorbing:     Rapidly absorbs aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI.*

Conforming: Compresses in the vessel lumen, providing more surface contact with vessel intima.

Expanding:    Expands up to four times the stated dry diameter when hydrated.

HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures: Embolisation of hepatocellular carcinoma and embolisation of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

Antonio Rivera
Senior Product Manager
1 Malagari K, Pomoni M, Moschouris H, Kelekis A, et al. Chemoembolization of hepatocellular carcinoma with Hepasphere 30-60 . Safety and efficacy study. Cardiovasc Intervent Radiol. 2014 Feb;37:165-175.

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.

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

Ostial PRO® Debuts in Turkey

Ostial PRO in Turkey

Merit Medical’s Ostial PRO Stent Positioning System was recently used for the first time in Turkey. The case was a renal aorto-ostial lesion performed by a cardiovascular surgeon at a University Hospital.

“The case went very well, and the cardiovascular surgeon liked the product very much,” Bahadir Şenol, Merit Medical Clinical Sales Specialist, said. “The surgeon plans to purchase additional Ostial PROs to have on-hand as they are needed.”

The Ostial PRO stent positioning system is an alignment tool with gold-plated “feet” that engage the aortic wall and allow easier assessment of the coronary or renal ostia, improving accuracy of stent positioning. In clinical studies, the Ostial PRO significantly increased the accuracy of aorto-ostial stent placement.1

“This is a product that can save lives,” Şenol said, adding that Merit Medical offers clinical support to doctors and hospitals that are interested in utilising the Ostial PRO. To learn more, contact your Merit Sales Representative or visit the Ostial Pro page on our website, which features a product video, several case studies, and documents such as brochures and instructions.

1 Data on file.

New Video Showcases Radial Portfolio

A new video showcases our extensive Radial portfolio, which includes products that support your radial procedure every step of the way – from preparation to haemostasis – providing procedural efficiency.  The new video highlights the benefits of radial access and includes our newest radial products, including the PreludeEASE™ Hydrophilic Sheath Introducer and the Rad Board® Radial Arm Board. To watch the new video, visit “Our Radial Products” on the Think Radial page.

HepaSphere Microspheres Absorb Both Mechanically and Ionically for Optimal Doxorubicin Loading

HepaSphere Microspheres are super absorbent polymer (SAP) microspheres made from vinyl acetate and methyl acrylate that combine to form a copolymer–sodium acrylate alcohol copolymer.

How do they work? HepaSphere Microspheres have the ability to load doxorubicin two ways: mechanically and through ionic interaction. Through mechanical interaction, HepaSphere Microspheres rapidly absorb aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI* and expand up to four times the stated dry diameter when hydrated. A recent study found that SAP have the ability to load 50 and 75 mg doxorubicin with ease of handling and optimal efficiency through dry loading.1

* Doxorubicin HCl used with HepaSphere Microspheres should be reconstituted with saline; never use pure water.

High Drug Loadability

MECHANICAL INTERACTION – HepaSphere Microspheres act as a reservoir and mechanically absorb aqueous solutions.

HepaSphere Mechanical Interaction

IONIC INTERACTION – The doxorubicin is loaded and eluted by a reversible ionic exchange mechanism.

HepaSphere Ionic Interaction

In the ionic interaction, the dry HepaSphere’s anionic polymer is negatively charged and absorbs the doxorubicin, which is positively charged or cationic.

Increased Tumour Necrosis

In a study on an animal model, the doxorubicin loading and efficiency of polyvinyl alcohol sodium acrylate copolymer microspheres were tested. The results found that Merit’s microspheres “can be efficiently loaded with doxorubicin” and that “histopathological tumour necrosis at 7 days was more prominent in the group treated with doxorubicin-loaded microspheres than in the bland embolisation group.” Both in vitro and in vivo studies showed a high drug loadability and sustained drug release over time, high intratumoural doxorubicin concentrations at each time point, and on histopathology, increased tumour necrosis.” 2

Efficient Loading

A study of doxorubicin eluting beads shows the difference in loading between HepaSphere Microspheres and another embolic brand. The study found that the competitor’s bead loaded only on the outer 20 microns of the bead. HepaSphere loads doxorubicin throughout the sphere.

HepaSphere Microspheres load doxorubicin throughout the microsphere.

HepaSphere bead

Competitor Bead – Confocal laser scanning microscopy images of dox-loaded beads (25 mgm/mL 500-700 micron bead). Image (below) shows progressive sections from the outside inwards at 10 micron intervals.3

HepaSphere bead competitor

For more information on HepaSphere Microspheres and loading of doxorubicin, explore the product’s website page or see our step-by-step reference guides:

HepaSphere Microspheres Lyophilized Doxorubicin Mixing Chart

HepaSphere Microspheres Presolubilized Doxorubicin Mixing Chart

The Merit Medical Embolics Team is ALWAYS available to answer any questions about our Embolics Portfolio. Contact Us.

Antonio Rivera, BSRT, MSHS

Global Product Manager

——————————————–

HepaSphere Microspheres are not approved or available for sale in the United States. In the European Union, HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the embolisation of hepatocellular carcinoma and the embolisation of metastases to the liver.

References

  1. Liu DM, Kos S, Buczkowski A, Kee S, Munk PL, Klass D, Wasan E. Optimization of doxorubicin loading for superabsorbent polymer microspheres: in vitro analysis. Cardiovasc Intervent Radiol. 2012 Apr;35(2):391-8.
  2. Lee KH, Liapi EA, et al. Doxorubicin-loaded QuadraSphere Microspheres: Plasma pharmacokinetics and intratumoral drug concentration in an animal model of liver cancer. Cariovasc Intervent Radiol. JUN 2010; 33(3):576-582.
  3. Lewis LL, Gonzalez MV, Leppard SW, Brown JE, Stratford PW, Phillips GJ, Lloyd AW. Doxorubicin eluting beads-1: Effects of drug loading on bead characteristics and drug distribution. J Mater Sci. Sep 2007;18(9):1691-1699.

 hepasphere

 

 

Study Finds Use of Hemostasis Patch Significantly Reduces Risk of Femoral Artery Compromise in Children

closurepadCardiac Interventions News presented in its May/June issue a study at the 2014 scientific sessions of The Society for Cardiovascular Angiography and Interventions (SCAI) entitled, “Femoral Artery Compromise from Cardiac Catheterization in Children–a Multicenter Study by the CCISC (Congenital Cardiovascular Interventional Study Consortium)” by Thomas J. Forbes, MD. The study concluded that the use of a 3 Fr sheath and haemostasis patch significantly reduced the risk of femoral artery compromise. The study found that “…when a ahemostatic patch was used to seal the wound, the risk of femoral compromise was reduced by approximately two-thirds compared with manual pressure alone.”
The Scion Clo-Sur
PLUS P.A.D.™, sold by Merit Medical, is a sterile topical haemostasis pad intended for the local management of bleeding wounds, including vascular procedure sites.
To learn more about the Scion Clo-sur
PLUS P.A.D., please visit the product’s web page, or contact your Merit Medical Sales Representative.

Mark Heninger
Senior Product Manager

 

Safeguard® Pressure Assisted Device: Trusted Femoral Performance Now Available for Radial Procedures

radial-haemostasis

Many of our customers use the Safeguard Pressure Assisted Device for haemostasis following femoral access procedures because they trust its compression, convenience and comfort. Merit Medical now has the Safeguard Radial™ compression device that offers the same trusted compression after radial procedures.

COMPRESSION                        

  • Inflatable bulb focuses compression only where you want it
  • It’s easy to adjust air in the bulb using a standard Luer lock syringe
  • Trusted compression, comfort and convenience
  • The base plate and the way the band wraps around the bulb provide stable positioning, not occlusion
  • You already know how important patent haemostasis is for a radial compression device and the Safeguard Radial allows you to achieve patent haemostasis with patient comfort as well

CONVENIENCE

  • While your patients come in many sizes, Safeguard Radial comes in one size that will fit them all
  • Having one compression device can reduce your inventory, maximise your precious storage space, and streamline ordering
  • You can use any syringe because Safeguard Radial has a standard Luer lock
  • The inflatable bulb lets you take distal and proximal pulses easily
  • The visibility of the clear bulb window allows you to check the access site

COMFORT

  • Just like the Safeguard femoral, the Safeguard Radial has a soft textile band with no plastic edges and a low profile design

So if you have been using the Safeguard for haemostasis following your femoral procedures, you can trust the Safeguard Radial to provide the same comfortable, convenient performance for radial compression.

Stephanie Poulsen

Senior Product Manager

ReSolve® Biliary Drainage Catheter Receives CE Mark

resolvebiliaryThe ReSolve Biliary Locking Drainage Catheter has received the CE mark and is available for sale in Europe.

These catheters are indicated for drainage of bile within the biliary system. Often biliary systems need to be decompressed due to bile duct stones, extrahepatic, or intrahepatic tumours, and primary sclerosing cholangitis, among other reasons. In addition, bile may also need to be diverted from a bile duct leak.

Biliary system lesions do not always occur in the same location in every patient. Because of this, Merit offers catheters with two different drainage hole configurations to accommodate patient anatomy and multiple disease locations.

Correct catheter positioning is important in these procedures. The catheter features a radiopaque marker band near the proximal shaft drainage hole, and non-radiopaque depth markers the entire length of the catheter to help with fast and accurate positioning.

Additional features:

• Atraumatic pigtail

• Smooth transitions

• Large drainage holes

• Hydrophilic coating

• Kink resistance

To learn more, please visit our ReSolve® Biliary Locking Drainage Catheter page.

 

Merit Medical EMEA Launches Website

MAASTRICHT, The Netherlands— Merit Medical EMEA today launched its new website, www.MeritEMEA.com.

The new website is a key component of the company’s vision to be the most customer-focused company in healthcare. The eye-catching, user-friendly site was built with Merit Medical’s customers in mind, prominently featuring the company’s diverse range of products. In addition, www.MeritEMEA.com provides healthcare professionals the opportunity to share their first-hand experiences with Merit Medical’s products.

“To be the most customer-focused company in healthcare, we must listen to our customers and value their feedback,” said Justin Lampropoulos, Merit Medical EMEA’s Executive Vice President. “Our new website provides an easy way for our healthcare partners to tell us what they like and dislike about our products. Their input is invaluable to us to innovate and deliver high-quality products that triumph the toughest clinical challenges and improve lives.”

The new EMEA website also highlights the “Think Radial. Discover Merit.” and “Think Embolics. Discover Merit.” campaigns and their integrated product portfolios. Additional www.MeritEMEA.com features include the ability to request a visit from a Merit Sales Rep, customer service phone numbers for the more than 16 countries within Merit Medical EMEA’s boundaries, and the company’s latest news and history.

ABOUT MERIT MEDICAL SYSTEMS, Inc. 

Merit Medical Systems, Inc. (NASDAQ: MMSI), has been designing, manufacturing and marketing single-use medical devices for more than 25 years and serves client hospitals worldwide with a domestic and international sales force totaling approximately 200 individuals. Merit Medical Systems employs approximately 3,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Maastricht and Venlo, the Netherlands; Paris, France; Galway, Ireland; Beijing, China; and Rockland, Massachusetts.