Summary
Cardiovascular diseases (CVDs) remain a major health problem worldwide and a leading cause of mortality, with over annual 18 million deaths. In Europe, CVDs are associated with 4 million deaths and costs of around €210 billion per year.
Many surgeries to treat cardiac conditions are shifting to be minimally invasive and this is a trend expected to continue growing due to its multiple advantages over open interventions. However, as newly developed devices for transcatheter procedures become bigger they also require larger vascular access sites. A couple of devices are used in vascular large-bore closure (e.g. ProGlide from Abbott). However, they are associated with still high vascular and bleeding complications (up to 20%, depending on the operator’s skills). Such complications are linked to longer hospitalizations, unnecessary suffering, and greater healthcare costs (€20k per patient), as well as higher morbidity and mortality.
To solve this persistent unmet need in the field of cardiovascular surgery, Novelrad has specifically developed the NVCD closure device. It integrates a proprietary and revolutionary micro-suturing technology that mimics the standard surgical technique, effectively delivering a multipoint continuous suture in a minimally invasive manner. The NVCD is easy to use and enables a safer closure of large bores, potentially reducing complication rates to 3%, saving up to 15 min in the procedure, and bringing important cost savings related to same-day discharge and complications’ management. Importantly, with a single NVCD device large and extra-large bore closure of veins and arteries is possible (up to 30Fr).
After obtaining a fully functional prototype of the NVCD and advancing in pre-clinical tests, we now aim to perform a first-in-human (FIH) study and complete the clinical trial required to obtain its CE certification as a Class III medical device. This will be crucial to prepare for industrialization and commercial deployment in Europe and globally.
Many surgeries to treat cardiac conditions are shifting to be minimally invasive and this is a trend expected to continue growing due to its multiple advantages over open interventions. However, as newly developed devices for transcatheter procedures become bigger they also require larger vascular access sites. A couple of devices are used in vascular large-bore closure (e.g. ProGlide from Abbott). However, they are associated with still high vascular and bleeding complications (up to 20%, depending on the operator’s skills). Such complications are linked to longer hospitalizations, unnecessary suffering, and greater healthcare costs (€20k per patient), as well as higher morbidity and mortality.
To solve this persistent unmet need in the field of cardiovascular surgery, Novelrad has specifically developed the NVCD closure device. It integrates a proprietary and revolutionary micro-suturing technology that mimics the standard surgical technique, effectively delivering a multipoint continuous suture in a minimally invasive manner. The NVCD is easy to use and enables a safer closure of large bores, potentially reducing complication rates to 3%, saving up to 15 min in the procedure, and bringing important cost savings related to same-day discharge and complications’ management. Importantly, with a single NVCD device large and extra-large bore closure of veins and arteries is possible (up to 30Fr).
After obtaining a fully functional prototype of the NVCD and advancing in pre-clinical tests, we now aim to perform a first-in-human (FIH) study and complete the clinical trial required to obtain its CE certification as a Class III medical device. This will be crucial to prepare for industrialization and commercial deployment in Europe and globally.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101166562 |
| Start date: | 01-08-2024 |
| End date: | 31-01-2027 |
| Total budget - Public funding: | 4 121 068,75 Euro - 2 499 999,00 Euro |
Cordis data
Original description
Cardiovascular diseases (CVDs) remain a major health problem worldwide and a leading cause of mortality, with over annual 18 million deaths. In Europe, CVDs are associated with 4 million deaths and costs of around €210 billion per year.Many surgeries to treat cardiac conditions are shifting to be minimally invasive and this is a trend expected to continue growing due to its multiple advantages over open interventions. However, as newly developed devices for transcatheter procedures become bigger they also require larger vascular access sites. A couple of devices are used in vascular large-bore closure (e.g. ProGlide from Abbott). However, they are associated with still high vascular and bleeding complications (up to 20%, depending on the operator’s skills). Such complications are linked to longer hospitalizations, unnecessary suffering, and greater healthcare costs (€20k per patient), as well as higher morbidity and mortality.
To solve this persistent unmet need in the field of cardiovascular surgery, Novelrad has specifically developed the NVCD closure device. It integrates a proprietary and revolutionary micro-suturing technology that mimics the standard surgical technique, effectively delivering a multipoint continuous suture in a minimally invasive manner. The NVCD is easy to use and enables a safer closure of large bores, potentially reducing complication rates to 3%, saving up to 15 min in the procedure, and bringing important cost savings related to same-day discharge and complications’ management. Importantly, with a single NVCD device large and extra-large bore closure of veins and arteries is possible (up to 30Fr).
After obtaining a fully functional prototype of the NVCD and advancing in pre-clinical tests, we now aim to perform a first-in-human (FIH) study and complete the clinical trial required to obtain its CE certification as a Class III medical device. This will be crucial to prepare for industrialization and commercial deployment in Europe and globally.
Status
SIGNEDCall topic
HORIZON-EIC-2023-ACCELERATOROPEN-01Update Date
25-11-2024
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