Minimally invasive suturing for vascular bore closure and heart defect repair

Introduction

Cardiovascular diseases (CVDs) remain a major health problem worldwide and a leading cause of mortality, with over 18 million deaths annually. In Europe, CVDs are associated with 4 million deaths and costs of around €210 billion per year.

Minimally Invasive Surgeries

Many surgeries to treat cardiac conditions are shifting to be minimally invasive, and this trend is 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.

Current Devices and Complications

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, with rates of up to 20%, depending on the operator’s skills. Such complications are linked to:

• Longer hospitalizations
• Unnecessary suffering
• Greater healthcare costs (€20k per patient)
• Higher morbidity and mortality

Novelrad's Solution

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.

Advantages of NVCD

The NVCD is easy to use and enables a safer closure of large bores, potentially reducing complication rates to 3%. It also offers:

1. Time savings of up to 15 minutes in the procedure
2. Important cost savings related to same-day discharge and complications’ management
3. The capability to perform large and extra-large bore closure of veins and arteries (up to 30Fr) with a single NVCD device

Future Plans

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.