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Our Technology
Huge Unmet Need
Chronic Venous Disease
News
Careers
Company
Contact
INVERA
*The InVera Infusion device is an investigational product and is not currently available for sale in the US, EU, or any other international market. It is intended solely for investigational research use at this time.
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emailINFUSION
DEVICE
Minimally invasive for reduced discomfort, faster delivery, and proven effectiveness with optimal outcomes.
The InVera Infusion Device is an innovative catheter system designed for the delivery of physician-specified agents, including sclerosants, to targeted veins in the peripheral vasculature.
The InVera Infusion device ensures delivery of the infused agent, optimised effectiveness while maintaining a minimally invasive approach.
Intuitive Method – based on current ultrasound techniques.
Minimally invasive infusion is performed following a single site injection of local anaesthesia in an office setting.
The InVera Infusion Device is an innovative, minimally invasive, infusion catheter designed specifically for controlled delivery to superficial veins of the lower limb peripheral vascular system.
The InVera Infusion device is designed for precise and efficient delivery of physician-specified agents in superficial leg veins via a single-use, disposable catheter-based solution. The innovative design includes a helical coil with a micro-textured lumen engaging outer surface that is capable of inducing venospasm and disrupting the vessel wall to expose the media layer. This creates the optimal environment for the infused agent to act on the target vessel wall.
With a proven safety profile, the InVera Infusion device is designed to enable precise and effective delivery of infused agents and enhance procedural efficiency while prioritising patient comfort.
* The InVera Infusion device is an investigational product and is not currently available for sale in the US, EU, or any other international market. It is intended solely for investigational research use at this time.
Key Features of the InVera Infusion Device
The InVera Infusion Device is a non-implanted, single-use, disposable catheter system designed for minimally invasive vascular treatments. It is introduced into the superficial venous circulatory system of the lower limb using a 5Fr Introducer sheath, ensuring smooth and controlled access to the treatment site.
Nitinol Helical Coil
Unique design with micro-textured lumen engaging outer surface and smooth inner surface. Precision laser cut textured surface disrupts the vein wall at a cellular, without catching or snagging in vein wall valves, for a smooth and intuitive withdrawal process.
Delivery Catheter
Holds the constrained coil during navigation and delivers physician-specified agents, such as sclerosants, to the target area. The catheter’s distal outer section is composed of spirally cut stainless-steel, combining strength and flexibility.
Ergonomic Pin and Pull Handle
Designed for easy deployment and recapture of the helical coil. An integrated infusion port with a standard luer connector allows for seamless agent delivery via an injection extension tube.
Safety and Performance Benefits of the Device
Precise Delivery
Engineered for targeted infusion of physician-specified agents to the vein lumen and sub-endothelial layers.
Intutitive Method
The device's design prioritises ease of use, allowing for quick integration into standard clinical practice. The procedure is straightforward and based on existing minimally invasive ultrasound-guided endovascular techniques.
Procedural Efficiency
The single-use, disposable design contributes to an efficient procedure flow across a range of clinical environments. No requirement for additional consoles or equipment.
Minimally Invasive
Introduced via a standard 5Fr introducer sheath. The Non-thermal, Non-Tumescent technique requires only a single injection of local anaesthetic at the introducer site, promoting a faster return to daily activities for patients.
Chronic Venous Disease
Chronic Venous Disease (CVD) occurs when blood is not circulating effectively around the body. It is typically caused by the failure of one-way valves which is known as superficial venous reflux, responsible for preventing blood flowing backwards in veins and results in blood pooling in the legs leading to a range of symptoms that progressively worsen over time. Over 80% of patients with CVD have abnormal superficial venous reflux, 5% of individuals with CVD experience more advanced symptoms every year.
Symptoms begin with varicose veins which are dilated, tortuous veins. This can progress to pain, heaviness, leg swelling, eczema and subsequent skin changes leading to the breakdown of the skin, and malodorous leaking venous ulcerations, in addition to cosmetic dissatisfaction.
* The InVera Infusion device is an investigational product and is not currently available for sale in the US, EU, or any other international market. It is intended solely for investigational research use at this time.
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A Huge Underestimated Healthcare Need
Venous disease affects one in four people and ranks as the 4th most common chronic disease in the world. This progressive venous disease culminates in debilitating venous leg ulcers that destroy quality of life for sufferers. It places a huge burden on health care systems, representing up to 3% of total healthcare budgets of western countries.
Only 1.3% of the 120 million people in the US & Europe who suffer from venous disease currently receive treatment each year.
Our device offers an unrivalled lower risk treatment which will allow more patients who suffer from venous disease to access effective treatment*.
* – This device is currently for Investigational Research Use Only. US & EU regulatory approval is anticipated in 2025.
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Commitment to Quality
InVera Medical is an ISO 13485 certified company and committed to providing high-quality products including the InVera Infusion device.*
InVera Medical has developed and implemented a quality management system to demonstrate its ability to consistently provide product that meets applicable quality and regulatory requirements. The quality system complies with the international standard ISO 13485:2016 for medical devices.
*The InVera Infusion device is an Investigational product and is not currently available for sale in the US, EU or any other international market. It is intended solely for investigational research use at this time. We are working towards regulatory approval in the US, EU and additional international markets.
Resources
Intended Use
InVera Infusion device is intended for the infusion of physician-specified agents, including sclerosant, into veins of the peripheral vasculature (e.g. superficial veins, saphenous veins).
Indications for Use
The InVera Infusion device is indicated for use in veins of the peripheral vasculature (e.g. superficial veins, saphenous veins) in adults.
InVera Infusion Device White Paper
A brief overview of the InVera Infusion device, presented in a simple document.
Read More trending_flatRelevant Publications
Kabnick LS, Phelan N, Cummins S, O Hynes S. A pre-clinical animal study of a novel mechanical-only ablation device treatment for superficial venous disease. Phlebology. 2022 Mar;37(2):112-119. doi: 10.1177/02683555211045868. Epub 2021 Sep 23. PMID: 34553616.
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Meet The InVera Medical Leadership Team
Stephen Cox
CEO & Co-Founder
Nigel Phelan
CMO & Co-Founder
Sean Cummins
CTO & Co-Founder
Aisling O'Sullivan
Vice President for Quality Assurance and Regulatory Affairs
Our team is growing.
Join us to bring the InVera Infusion device to the market. Let's build.
We seek talented people, who will lead and innovate to make a positive impact in a fast-paced patient-focused environment. Contact the InVera Medical™ team at info@inveramedical.com.
Our Values are important. We're always interested to hear from people who share them:
Patient First
A commitment to delivery of safe and effective solutions that improve the quality of life of our patients.
High-Quality Customers Delivery
To deliver a high-quality sustainable product and service to our customers at a reasonable price.
Purposeful Innovation
To use scientific research to further develop the understanding of unmet clinical needs to benefit patients.
Employee Enrichment
To provide a respectful environment where employees can thrive with calculated bias for action.
Strong Shareholder Position
To achieve strong returns and positive cash position to swiftly capitalise on future opportuntiies.
InVera Medical™ is an equal opportunities employer.
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with us
The InVera Infusion device is an Investigational product and is not currently available for sale in the US, EU or any other international market. It is intended solely for investigational research use at this time. We are working towards regulatory approval in the US, EU and additional international markets.
How to find us
InVera Medical Limited
Unit 113 Innovation Hub
Dublin Road
Galway, Ireland
H91 DCH9
