Interventional approaches to venous clot management have been historically deficient leading to the increased use of thrombolytics and medical management to address clot burden.
Retriever Medical, a private medical device company, seeks to transform the interventional approach to venous clot extraction with their proprietary SentryDuo Mechanical Thrombectomy Aspiration System, allowing physicians to treat both Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) without the need for thrombolytics and extensive ICU stay. SentryDuo is the only mechanical thrombectomy system that provides a single design for PE and DVT procedures. Further, it is the only mechanical thrombectomy system to provide active expansion of two independently moveable spheres to disrupt, capture, and extract venous clot, offering controlled wall-to-wall vessel contact in a single session. The proximal sphere design allows physicians to mobilize clot by axially moving 6 cm along the device shaft in a backwards and forwards direction, safely performing luminal wall curettage.
“Retriever leverages a highly innovative technology to capture blood clots from the pulmonary arterial and peripheral venous system. The combination of the team, technology and significant opportunity underline an exciting and compelling path forward for Retriever” – Rich Ferrari, MBA, Chairman of the Board, Retriever Medical.
Retriever’s SentryDuo System is designed to accelerate the shift in care from medical management (thrombolytics) to an interventional based approach offering a non-thrombolytic solution. The Retriever System is designed with a series of custom Aspiration Catheters to work in conjunction with the mechanical catheter to facilitate clot extractions. SentryDuo’s Integrated actuator handle allows for ambidextrous, single-handed control of the device’s proximal and distal spheres. Simultaneous, individually tailored sphere diameter adjustment SentryDuo™ PE and axial movement is achieved using simple, low fatigue, thumb manipulation of three ergonomically positioned sliders positioned on the handle’s dorsal surface. The design of two independent mechanical sphere capability, wall-to-wall vessel contact, and a proximal sphere designed to move backwards and forwards 6 cm, allows the surgeon to conduct precise mechanical curettage of more organized subacute clot, while eliminating thrombolytics, reducing blood loss and minimizing ICU stay times. This allows patients to recover more quickly without extended stay times in the hospital.
According to Retriever’s CEO, Ben Bobo, “Retriever’s system is designed for mechanical thrombectomy to address more organized subacute clot, thus minimizing the need for aspiration. Traditional thrombectomy technologies have focused efforts on aspiration and thrombolytics, targeting centrally located acute/soft thrombus and as a result, more organized subacute clot is unable to be extracted potentially compromising outcomes.”
Retriever’s thrombectomy device has been reviewed by the FDA in a pre-sub meeting and received guidance on the 510(k) pathway. The technology is covered by three issued patents, and the Company has filed 3 additional provisional patents applications in 2021, including ones covering the SentryDuo system and a femoral closure device. The Company completed an FTO analysis in 2021. There is strong, established reimbursement in place for both PE and DVT procedures.