Registry Update

Enrollment Update: DuraGraft® Registry Enrollment as of May 4, 2018 is 35 active enrolling sites and 1,454 patients enrolled!

The participating countries include: Austria, Germany, Ireland, Italy, Spain, Switzerland, Turkey and the United Kingdom.

Best Practices

Seville, Spain: Carlos Ortiz and the Com Medcor team led a successful clinical presentation event in Seville, Spain. The meeting included 15 Spanish Investigators, Com Medcor, and the Somahlution leadership team. It was strategically planned around the April Fira festival that takes place in Seville. Dr. Cuerpo gave a clinical presentation, which was subsequently followed by an in-depth discussion regarding guidelines of cardiac intervention at respective hospitals. After the clinical discussion, Carlos arranged for all participants to travel and enjoy the Seville festival in his own caseta.

Somahlution is pleased to announce the first commercial order of DuraGraft in Spain from University Gregorio Maranon, Spain. This is a great achievement as it is the first order that has come from a Registry participant to be used commercially.

Clinical Industry Update

Radial-artery grafts outperform saphenous-vein grafts when used in CABG: The RADIAL trial

In this meta-analysis of six randomized controlled trials, the safety and efficacy of radial-artery grafts was compared with those of saphenous-vein grafts in coronary-artery bypass grafting (CABG). Compared with saphenous-vein grafts (SVG), radial-artery grafts were associated with a significantly lower incidence of adverse cardiac events as well as a significantly lower risk of occlusion. Although rates of MI and repeat vascularization were also somewhat lower with radial-artery grafts, the overall incidence of death was comparable between radial-artery and saphenous-vein grafts.

Over five-year follow-up, radial-artery grafts showed superiority in safety and efficacy compared with saphenous-vein grafts in CABG.

Key Takeaways:

•  While radial-artery grafts have a better long-term outcome they are only used in a small proportion of the patients: “In the United States, less than 10% of patients who undergo elective CABG receive more than one arterial graft, and a radial-artery graft is used in less than 7%.”
•  Both radial-artery grafts and SVG are associated with graft failure (SVG >> RA): ” The incidence rates for graft occlusion were 19 events per 1000 patient-years in the radial-artery group versus 46 events per 1000 patient-years in the saphenous-vein group; radial-artery grafts were associated with a significantly lower risk of occlusion (hazard ratio, 0.44; 95% CI, 0.28 to 0.70; P<0.001)
•  The curves indicating graft failure start to separate after three years and the incidence is approx. 25% and 50% after nine years and this in a patient population with a mean age of 67 years.
•  Graft failure is a frequent problem and relevant medical issue.
•  The use of DuraGraft with SVG’s has the potential to achieve similar long-term clinical outcomes as the use of radial-artery grafts for CABG. See summary of reduction in event rates from the DuraGraft VA Study below:

For more information on the Radial study, please click here: https://www.nejm.org/doi/full/10.1056/NEJMoa1716026

New Sales Tools

The DuraGraft marketing sharefile has been updated to include all current DuraGraft selling tools and collateral. Please visit, https://somahlution.sharefile.com to view and download all current materials.
Please note:
1. Delete all old files on your computer and other devices to ensure you are using the latest version.
2. Familiarize yourselves with the approved documents and know what to use when.

You will find the following new and updated documents
•  Speaker Deck
•  Pathway to validation video
•  Dare to Compare Brochure
•  Patient Brochure
•  Easy Prep
•  Biseko Whitepaper
•  Study Design, published in Open Heart Journal April 2018
•  Two-page summary

We will be sending each of you a packet of new brochures!

Upcoming Events

Save the Date – EACTS 2018 – Milan, Italy – October 18 – 20, 2018
Somahlution plans to participate at the EACTS Annual Meeting as an exhibitor with a DuraGraft booth. We will highlight the most updated clinical data, publications, and patient registry. We will also hold our annual distributor training prior to the meeting. Be sure to let us know if you are planning to attend EACTS so we can arrange schedules accordingly.

More details to follow…

Past Events

AATS The American Association for Thoracic Surgery Convention took place April 28 – May 1, 2018 at the San Diego Convention Center in San Diego, CA. The Somahlution leadership team hosted an intimate dinner event for a small group of surgeons highlighting clinical study updates and continuing to raise awareness of DuraGraft.

EuroPCR Two abstract posters on the DuraGraft Prospective Study were accepted as part of their “Poster Lab” digital space for e-posters.
Please click here to see the abstract posters, https://somahlution.sharefile.com/d-s313dee8b251475bb

XXIV Congress of the Spanish Society of Thoracic-Cardiovascular Surgery
Com Medcor and Somahlution represented DuraGraft at the XXIV National Congress meeting in Spain. Over 200 surgeons attended the event. Dr. Cuerpo was invited to speak at the event and his presentation, including DuraGraft, was a great success.
Please click here to see photos from this event, https://somahlution.sharefile.com/d-sc24557ff21846ec8

Annual Meeting of the Austrian Society of Cardiology (ASC) 2018
MEDOVIS healthcare team represented DuraGraft with a great display at the 2018 ASC. This meeting took place June 6 – 9, 2018 in Zalzubrg, Austria.
Please click here to see the team photo