Merit Medical Receives 510(k) Clearance for ASAPLP™ Low Profile Aspiration Catheter

I’m pleased to announce that we have received 510(k) clearance for the ASAPLP Low Profile Aspiration Catheter, a new low-profile addition to our ASAP® line of aspiration catheters. The ASAPLP received the CE mark on August 30.

asaplp

The ASAPLP is designed to remove fresh, soft emboli and thrombi from vessels of the arterial system.

QUICK ASPIRATION

  • Fits into 6F guide catheter of ≥0.066” with ease
  • A 4F catheter designed for maximum aspiration
  • Long 30 cm hydrophilic coating promoting deliverability
  • Longer 20 cm rapid exchange lumen designed for better wire trackability

EFFECTIVE

  • 100% stainless steel braided, kink resistant 145 cm low profile aspiration catheter
  • Improved tip radiopacity due to radiopaque platinum iridium marker band
  • Bright colored wire exchange lumen

OPTIONS

  • Packaged with stiffening stylet

ASAPLP is Merit Medical’s latest innovation for quick, effective aspiration! For more information on the ASAP line of aspiration catheters, see the the Aspiration Catheter Family Brochure.

Elizabeth Pratt
Senior Product Manager

Cynthia Bailey, The Real Housewives of Atlanta Cast Member, Will Undergo Uterine Fibroid Embolization on November 17 Episode

Cynthia Bailey revealed that she had fibroids in last week’s episode of the Real Housewives of Atlanta. Cynthia complained of heavy bleeding and long menstrual periods and the toll it was taking on her body and her personal life.

On the episode, set to air on Sunday, November 17 at 8 PM Eastern time, the cameras will be present when Cynthia undergoes a uterine fibroid embolization (UFE) procedure. Cynthia described the results of her UFE procedure in a recent interview as “life changing.” “Everything has changed and it has been amazing. I’m so glad I took care of it.” She said that she decided to share this experience to promote public awareness of uterine fibroids.

Uterine fibroids affect millions of women between the ages of 20 and 50 and are more common in African American women. Bailey hopes that fans will be inspired by her story.

Merit Medical sponsors an informational resource, the ask4UFE.com website, devoted to educating women about fibroids, treatment options, and UFE. The website includes a Physician Locator Tool to help women find physicians in their area who perform the UFE procedure.

ask4ufe logo

Merit Medical also offers embolization products that are used in uterine fibroid embolization (UFE) procedures: Embosphere® Microspheres and Bearing nsPVA™ nonspherical polyvinyl alcohol embolization particles. UFE is a less invasive treatment than hysterectomy. Go to http://www.ask4UFE.com today to determine if UFE is the right treatment option for you.

Comparison of Radiofrequency-targeted Vertebral Augmentation with Balloon Kyphoplasty for the Treatment of Vertebral Compression Fractures: 2-year Results.

Bornemann R, Jansen TR, Kabir K, Pennekamp PH, Stüwe B, Wirtz DC, Pflugmacher R. J Spinal Disord Tech. 2013 Pubmed PMID: 24247030 OBJECTIVES:

Evaluation of safety and effectiveness of radiofrequency-targeted vertebral, augmentation (RF-TVA) in comparison to balloon kyphoplasty (BK) for the treatment of, acute painful vertebral compression fractures (VCF) on the basis of matched pairs.

METHODS:

A total of 192 patients (116 females; 51 – 90 y) with VCF (n=303) at one to three, levels were treated with RF-TVA or BK. Functionality (ODI), pain (VAS), vertebral, height (anterior, middle) and kyphotic angle were evaluated over a two year period, (postoperatively, 3-4 d, 3, 6, 12 and 24 mo). Additionally, operating time and, occurrence of cement leakage were recorded.

RESULTS:

Pain and functionality were significantly improved after both treatments. In both groups, there was an increase in vertebral height and a decrease in kyphotic angle, which, remained relatively consistent during 24 months. The incidence of cement leakage was, 9.4% (n=9) in the RF-TVA group and 24.0% (n=25) in the BK group. The mean, operating time with radiofrequency kyphoplasty was 25.9±9.9 minutes and with balloon, kyphoplasty 48.0±18.4 minutes.

CONCLUSION:

RF-TVA is a safe and effective procedure for the treatment of vertebral compression, fractures when compared to BK. Improvement in pain and functional scores following, RF-TVA are durable through 24 months post-procedure and remained better than, those following BK at long term follow up. Operating time for RF-TVA is shorter and the, risk of cement leakage is lower. Both procedures provided similar results in vertebral, height restoration and reduction in kyphotic angle.

Merit Medical Exhibiting at 2013 AIM & VEITH Symposiums in New York, November 18-23, 2013

Merit Medical is proud to support AIM & VEITH, which will include educational sessions on the latest developments in interventional radiology, oncology, cardiology and vascular access.

We would like you to join us as we display our “Big Apple” welcome at AIM Booth 420 and VEITH Booth 110. Featured products will include:

We look forward to seeing you in New York City!

Patty Jabotte
Marketing Communications Manager

*Not currently available in the US  510(k) review pending

Merit Medical Adds 2 New Products for Assisting Hemostasis

safeguard

I’m excited about the recent announcement of Merit Medical’s acquisition of the Safeguard® products for assisting hemostasis. The Safeguard 12 cm and 24 cm Pressure Assisted Devices are latex-free, self-adhesive dressings designed to assist in obtaining and maintaining hemostasis. The 24-cm device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures with an ACT of 140 seconds or less, using a 6 F and smaller sheath size.

Safeguard Product Features

Ergonomic
•       Hands-free adjustable pressure of the puncture site
•       Inflatable bulb and standard Luer valve for easy inflation and deflation with any standard Luer syringe

Visibility
•       Clear window allows better visibility of the puncture site

Comfortable
•       Safeguard maintains a consistent pressure
•       87% of patients in a study indicated that Safeguard was “much more comfortable” than manual compression alone1

Secure
•       Adhesive provides a secure fit and minimizes movement or dislocation

Merit Medical’s growing portfolio of hemostasis products now includes the Safeguard, the Finale® and the RADstat® Radial Compression Devices and the Clo-Sur PLUS P.A.D.™ Antimicrobial Barrier.

Mark Heninger
Senior Product Manager

1 Roberts, A et al. Safeguard Manual Assist Technique: The SMAT Study. Cath Lab Digest, June 2008:38.