05 Jun, 2019

NICE Publishes a Medtech Innovation Briefing (MIB) on DuraGraft® for Preserving Vascular Grafts and Associated Endothelium used in Coronary Artery Bypass Graft (CABG) Surgery.

05 Jun, 2019

Somahlution’s DuraGraft; an intraoperative vascular graft preservation solution shown to lower complications and adverse events post-CABG surgery.

 

JUPITER, FL – May 23, 2019 — Somahlution, a global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, announces that the UK’s National Institute for Health and Care Excellence (NICE) has issued a Medtech Innovation Briefing (MIB) on DuraGraft® for preserving vascular grafts.[i]

The MIB reports on the use of DuraGraft for storing and flushing harvested vessels during coronary artery bypass graft (CABG) or peripheral vascular procedures.  It advises DuraGraft may be a more effective alternative to standard handling formulations such as saline or blood-based solutions. Evidence shows that the use of DuraGraft may lower the risk of developing complications and adverse events after CABG. This ultimately limits the need for repeat revascularization and hospital admissions after surgery, making DuraGraft technology a key benefit to the healthcare system.

Clinical evidence from two studies supports the safety and performance of DuraGraft. In the larger study,[ii] the use of DuraGraft is associated with statistically significant lower risks for clinical complications following CABG; 45% in non-fatal myocardial infarction (MI) (p <0.0001), 35% reduction in repeat revascularization (p=0.037), and 19% reduction of MACE (a composite of all major adverse cardiac events) (p=0.005), based on analysis of data from 1000 days up to 15 years  post-surgery.

Medical specialists from the UK were approached by NICE to share their opinions about DuraGraft, and their comments are included in the MIB report. All agreed that DuraGraft technology is a novel concept and has the potential to improve the patency of vein grafts.  They believe DuraGraft is innovative in its formulation, includes components that preserve the endothelium of the grafts, and is better than the current standard of care solutions (saline or blood-based solutions).  The specialists also mention that there is no other solution designed specifically for endothelial protection available in the NHS. Most agreed that the technology would be of the greatest benefit for patients having CABG using saphenous vein conduits. A few experts thought that patients who are prone to early graft failure would particularly benefit.

“We believe the MIB underlies an important recognition of a product that helps reduce the risk of developing complications and adverse events after CABG,” said Satish Chandran, CEO of Somahlution. “There are thousands of patients in the UK that undergo CABG surgery every year. Now, with the published MIB from NICE, we hope more people will understand and appreciate the benefits and evidence supporting this first-in-class intraoperative graft preservation solution.”

 

 

 

 

About Somahlution

Somahlution is a global leader in the development of products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications. The company’s flagship product, DuraGraft, is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications associated with graft failure. DuraGraft enhances CABG surgical outcomes by significantly reducing major cardiac events such as repeat revascularization and myocardial infarction.

For more information about the company, please visit www.somahlution.com

About NICE Medtech Innovation Briefings

NICE Medtech Innovation Briefings (MIBs) are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The information provided includes a description of the technology, how it’s used and its potential role in the treatment pathway, as well as a review of relevant published evidence and the likely costs of using the technologies. MIBs are designed to be fast, flexible and responsive to the need for information on innovative technologies.[iii]

Read more about NICE’s findings, click here

Contacts

Somahlution

Karen Coviello, 561-433-6630

Marketing Communications

Karen.Coviello@Somahlution.com

[i] NICE Medtech Innovation Briefing

[ii] Miguel Haime, Robert R. McLean, Katherine E. Kurgansky, Maximilian Y. Emmert, Nicole Kosik, Constance Nelson, Michael J. Gaziano, Kelly Cho & David R. Gagnon (2018) Relationship between intra-operative vein graft treatment with DuraGraft® or saline and clinical outcomes after coronary artery bypass grafting, Expert Review of Cardiovascular Therapy, 16:12, 963-970, DOI: 10.1080/14779072.2018.1532289

[iii] Medtech innovation briefings: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/medtech-innovation-briefings

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