Registry Update

Enrollment Update: DuraGraft® Registry Enrollment as of Sept 13, 2018 is 37 active enrolling sites and 1,985 patients enrolled!

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

Best Practices

Handling Hospital Inclusions – “Getting Through The Gate”.
By Jonald Asbin – Somahlution Product Specialist

When DuraGraft was introduced to the Philippines market in 2016, Jonald faced a tough battle getting it into the largest CABG center – The Philippine Heart Center (PHC). PHC ranks as one of the leading medical institutions in Asia for the medical and surgical treatment of heart diseases. The Center admits more than 14,000 patients yearly, of whom more than 3,300 undergo heart surgery. Like many hospitals, companies who wish to have their products introduced to the hospital must meet the following requirements:

 

 

  • Have an entity in the Philippines
  • Published clinical trials in respected, international journals
  • In the market internationally for a minimum of three years
  • Philippines market for two years
  • Must complete all local FDA requirements and licensing
  • Must be endorsed by 10 active surgeons in the Philippines

 

Despite not meeting all the PHC requirements for new products. Jonald had a strategy to work from the ground up to get his foot in the door and introduce DuraGraft. “I told myself that if 70% of all CVTS practices are done here and 70% of all CABG in the country happens here (at PHC), it only makes sense to spend 70% of my time here and find ways to get to commercialization and find ways to solve problems.”

Jonald’s game-plan:

  • Befriend the MD’s secretaries to gain access to their office hours and schedule appointments.
  • Schedule individual or group (department staff) product presentations.
  • Have a “champion” (surgeon) to endorse your product through the channels as an exception for product evaluation.
 

“Convincing these doctors must start with excellent product knowledge and belief in our product, the life-changing DuraGraft. It is important to be able to sell its value proposition and make MDs shift paradigm from Heparinized Saline use to using a product that cost 7-10% of the total CABG procedure.”

Once you have the surgeons believing in the DuraGraft story, utilize your “champions” to help push the product for the “exemption” despite the difficult inclusion criteria. Another big challenge is getting DuraGraft passed through the Pharmacy, Insurance and Consignment department and it all this is part of the difficult process in the evaluation phase of the product.

With determination, patience, and educating KOLs and staff on DuraGraft’s simplicity as a product and large clinical significance, Jonald was able to get DuraGraft through the Consignment and they have so far used more than 150 units. By the end of this year, evaluation for actual inclusion can be started and since many people from the hospital already know the product, the technical requirements are now expected to come second to actual endorsements from all departments (MDs, Pharmacy, Insurance, Nursing, and Consignment dept).

The best practice in summary, “NO means the task will not be “EASY” so we have to be MORE persistent, consistent and insistent.”

Thank you Jonald for your excellent feedback and persistence. Please keep up the good work.

DuraGraft Clinical News and Tools

Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data.
Head et al., The Lancet 2018 

A recent study by Head and colleagues, published in The Lancet, pooled an analysis of data collected from 11 randomized trials that investigated patient survival rates after CABG or PCI intervention. The analysis revealed that the risk of death of patients that underwent CABG versus PCI was similar during the first year after surgery. Following the first year, however, the risk of death was significantly lower in patients that underwent CABG compared to PCI.

Key Takeaways:

  • The recently published study in Lancet (Head et al. 2018, attached) involving 11,518 patients who were assigned to PCI (n=5753) or to CABG (n=5765), is the first trial powered to detect a difference in mortality between these two revascularization strategies.
  • The study concluded that CABG had a mortality benefit over PCI in patients with multivessel disease, particularly in diabetic and severe CAD patients confirming results of the FREEDOM (Farkouh et al, 2012) and SYNTAX (Kappetein et al, 2013) trials.
  • All these trials affirm CABG as the treatment of choice when revascularization in patients with complex multivessel disease and diabetes is deemed to be necessary, assuming the patient is an appropriate surgical candidate (Bahtt 2018).

New Sales Tools

The DuraGraft marketing sharefile has been updated to include all current DuraGraft selling tools and collateral. Please visit, somahlution.sharefile.com, to view and download all current materials.

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
  • US Evaluation Whitepaper
  • DuraGraft Brochure English and Spanish

Upcoming Events

EACTS 2018 – Milan, Italy – October 18 – 20, 2018

Somahlution will have live hands-on demonstrations at the booth showcasing the difference between the standard of care solutions and DuraGraft. Please see the schedule below and share the invite with your clinicians.

Click here for the invite.

Past Events

We held successful Acceleration Dinners between June and July with clinicians from some of the registry sites and clinical team. Thanks to Somahlution’s Frank Van Leeuwen, MD (Frank) for traveling to all of the locations and presenting to the group. See recap below:
 
The Frankfurt Team started at The Heart Center with a clinical presentation by Dr. Maximilian Emmert (Max). The Frankfurt team with Dr. Holubec was motivated to participate in the registry and have enrolled 22 patients thus far. The head of the department, Prof. Walther joined the meeting as well. After the presentation, the group continued the discussion over dinner at a nearby restaurant. All participants had constructive conversations with Frank, Max and the Frankfurt team.
 
Munich Heart Center and HeartCor Team had an intimate dinner with the Vice Director, Dr. Krane, and registry study PI, Dr. Böhm. Frank shared the DuraGraft clinical presentation with those at dinner that helped open the door for more productive conversation.
 
Leipzig Heart Team and HeartCor were joined by Frank and Ben Modley for a clinical presentation over dinner, which was followed by a more in-depth discussion of DuraGraft and the clinical benefits it offers. Leipzig Heart team is clearly excited to be part of the EU registry.