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CORDIS

Laser-Assisted Surgical System to Revolutionize Cardiac Bypass Surgeries

Project description

Elana Heart Bypass to Revolutionize Coronary Artery Bypass Grafting

Coronary Artery Bypass Grafting (CABG) is used to treat severe coronary artery disease, and prevents myocardial infarction (heart attack). Performed on an arrested (non-beating) heart and via a large incision, this procedure is highly invasive. The ELANA Heart Bypass system enables minimally invasive CABG via a laser-assisted procedure on the beating heart without opening the chest. This directly impels shorter recovery and less complications for the patients. The EU-funded SAFE-CAB project plans to accelerate the time to market of this product through final clinical validation and regulatory certification. Their goal is to replace invasive CABG with the ELANA Heart Bypass, as the new standard of care. Minimally invasive CABG could significantly reduce recovery times, complications, and hospital costs. Being the new standard of care, the ELANA Heart Bypass could dramatically improve patient outcomes.

Objective

Coronary Artery Bypass (CAB) surgery is performed annually in >700,000 patients to treat coronary artery disease and
prevent myocardial infarction (heart attack). Standard CAB surgery involves a highly invasive open-heart procedure in
arrested/non-beating heart, that is associated with long recovery times and severe complications. The surgeons are seeking
for less invasive, closed chest CAB procedures on beating heart, but current solutions are technically extremely challenging and thereby
only used in <1-3% of all surgeries. The vision of the SAFE-CAB consortium is to make the minimally invasive CAB
surgeries available to all surgeons as a novel standard of care, thereby substantially improve patient outcomes and reduce
health care costs. The goal of the project is to bring to market a first-of-its-kind laser-assisted minimally invasive surgical
system (surgical kit containing surgical implant and laser catheter). SAFE-CAB enables minimally invasive procedure on
beating heart, without the need for arresting blood flow or complex hand suturing. With shorter recovery times, less
complications and improved survival rates in high-risk patients, the SAFE-CAB technology has a potential to replace high-risk
open-heart surgeries. Replacing only 15% of open-heart surgeries in Europe and US translates to annual
market opportunity of >€89M and >€192M. Dutch SME AMT Medical has developed the proprietary SAFE-CAB
technology to clinical readiness. To substantially accelerate the market entry of the product, the company partners with a leading European cardiac surgery hospital Deutsches Herzzentrum Berlin and a pan-European clinical/regulatory medical device company HEMEX to
obtain regulatory approval through final clinical validation . To realize European wide-implementation, the consortium is complemented by a surgery training company LifeTec Group and the oldest professional organisation for cardiac surgeons European Society of CardioVascular and Endovascular Surgery.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

IA - Innovation action

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Call for proposal

(opens in new window) H2020-EIC-FTI-2018-2020

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Coordinator

AMT MEDICAL RESEARCH BV
Net EU contribution
€ 397 250,00
Address
YALELAAN 52
3584 CM Utrecht
Netherlands
SME
Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 567 500,00

Participants (5)