Prevelance, Management and Outcomes
The prevalence of PAD in the general population is approx 5.6%, however this increases exponentially with age, with > 20% of people suffering from PAD.
Critical limb ischemia (CLI) represents the most advanced clinical manifestation of peripheral arterial disease (PAD). CLI results from severe blockages in the arteries of the lower extremities, which significantly reduces blood flow, and eventually completely blocks the artery and creates a Chronic Total Occlusion (CTO). Critical limb ischemia is a severe condition and that requires immediate treatment to re-establish blood flow to the affected area. The prognosis for patients presenting with CLI is very poor, with 25% dead at 1 year, 30% amputated (which carries an additional mortality rate of 70% at 5 years).
“…PAD and CLI remains a largely underdiagnosed and untreated disease … a vast unmet need exists with respect to diagnosis and treatment.”
Magnitude of Risk Factors for Developing CLI
PAD and CLI already affect a substantial proportion of the population, particularly the over 65 years age group. The public is poorly informed about PAD, with only 25% reported an awareness. These knowledge gaps include the risk factors that lead to PAD and CLI and the associated limb symptoms and amputation risk.
Management of CLI
The primary goal in the treatment of CLI is to revascularise the limb and preserve function. Unfortunately, there remain almost 400K major and minor amputations in the US and EU every year as a result of CLI.
Endovascular Therapy offers patients a minimally invasive staged approach to preserve the limbs and reduce disability.
1 Year Outcomes of Patients with CLI
Patients treated with CLI have a high rate of hospital readmission within 1 year after initial treatment. Major and Minor amputations may be indicated for failed revascularisation, patients with extensive tissue loss, infection or non-ambulating patients. However as amputation carries a 70% mortality rate at 5 years, clinicians are eager to find better, longer-lasting treatment options for their patients.
The Problem
Chronic Total Occlusions (CTOs) are present in 50% of patients treated for Critical Limb Ischemia (CLI). Calcified segments prevent guidewires passing through these blockages. Instead, physicians try to go around the lesion which is technically difficult, time consuming and often leads to a failed procedure resulting in further open vascular surgery or even amputation.
Ideal Solution
To facilitate endovascular treatment of CTO lesions guidewires must complete three tasks to enable the therapy to be delivered;
- Cross Complex lesions within the vessel.
- Prepare working lumen to facilitate treatment.
- Support the follow on device.
Versono’s Approach
Versono is designing a simple and reliable system to cross complex, chronic and acute vascular occulsions, preparing a working lumen and supporting follow on devices. The novel intravascular ultrasonic system is designed to cross, prepare and support endovascular CLI therapy.
Our Story
Versono’s team bring a wealth of experience and expertise having worked for decades in the vascular device design and development. The company recognises the challenges associated with treating complex chronic and acute vascular occlusions limit access to endovascular treatment for millions of patients annually.
The company’s focus is on developing and commercialising a new technology platform for endovascular surgery that will focus initially on patients with Critical Limb Threatening Ischemia (CLTI), the most severe and advanced clinical manifestation of Peripheral Arterial Disease (PAD). Versono’s mission is to enable endovascular treatment of Complex Chronic Total Occlusions in order to address poor patient outcomes, high amputation and high mortality rates associated with CLTI.
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