VesselSens developes a smart therapeutic monitoring device, StentGuard, for rapid, reliable, low cost and early diagnosis of restenosis non-invasively. The device consists of a stent with integrated sensors (1), a read out unit (2) and a web based server (3) which processes data giving a traffic light display output (4) to support diagnosis (using NASCET criteria). StentGuard determines the degree of restenosis based on the pulse wave pressure difference inside the stent and allows frequent stent monitoring at low cost
by non-specialist medical practitioners. The relevant data can even be accessed with a smartphone and displayed to doctors and to patients. This solves the clinical challenge of infrequent monitoring and facilitates early diagnosis of restenosis.
|Areas:||Life Science / MedTech|
|Goal/ Vision:||a.) Globally >237 million people suffer from peripheral artery
disease (PAD) and ~3.5 m stentsare implanted every year as first line therapy. Critically, restenosis – the gradual reclogging of the blood vessel after stent implantation – is a major problem even with modern stents leading to limb amputation (due to critical limb ischemia) and death.
Frequently monitoring stent-implants is the most effective way to prevent restenosis. Currently, patients must visit a doctor every 3-6 months in the first year of implantation. If conspicuity is observed, costly follow up diagnostic procedures are required such as duplex sonography (~€500), computer tomography (>€330) or MRI (>€370). This makes frequent monitoring unsustainable, while the need for a medical specialist to administer and limited equipment creates a bottleneck for patient flowthrough. Critical limb ischemia (CLI, latestage PAD) afflicts >3.5 m people worldwide p.a. and ~25 % of CLIpatients undergo amputation due to unchecked disease progression.
b.) The global stent market is valued at €9.35 bn. VesselSens will target the global peripheral stent market which was valued at €1.92 bn in 2019. Rising prevalence of cardiovascular diseases in an aging population is expected to propel the demand for stents over the forecast period. 11 % of stent-sales are made by European companies and the annual
|Institute:||Fraunhofer IPA > Life Science Inkubator Betriebs GmbH & Co. KG / MPF > VesselSens GmbH|