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Solution Minimally invasive for reduced discomfort, faster delivery, and proven effectiveness with optimal outcomes. Solution 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. Solution Intuitive Method – based on current ultrasound techniques.

Minimally invasive infusion is performed following a single site injection of local anaesthesia in an office setting. INVERA CE Mark The InVera Infusion device has received FDA 510(k) clearance in the United States and CE Mark
approval from BSI (NB 2797) under MDR 2017/745 for use in the European Union.
It is authorised for commercial sale in the US and EU in accordance with its approved indications
and remains investigational in all other territories. Get in touch email INFUSION DEVICE InVera Infusion Device

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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 has received FDA 510(k) clearance in the United States and CE Mark approval from BSI (NB 2797) under MDR 2017/745 for use in the European Union. It is authorised for commercial sale in the US and EU in accordance with its approved indications and remains investigational in all other territories.

Slide 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.

Slide 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.

Slide 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 has received FDA 510(k) clearance in the United States and CE Mark approval from BSI (NB 2797) under MDR 2017/745 for use in the European Union. It is authorised for commercial sale in the US and EU in accordance with its approved indications and remains investigational in all other territories. Click here to watch video

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Slide 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*.

The InVera Infusion device has received FDA 510(k) clearance in the United States and CE Mark approval from BSI (NB 2797) under MDR 2017/745 for use in the European Union. It is authorised for commercial sale in the US and EU in accordance with its approved indications and remains investigational in all other territories. Click here to watch video

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Slide 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.

ISO 13585 BSI


* The InVera Infusion device has received FDA 510(k) clearance in the United States and CE Mark approval from BSI (NB 2797) under MDR 2017/745 for use in the European Union. It is authorised for commercial sale in the US and EU in accordance with its approved indications and remains investigational in all other territories.

Slide 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.
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* IFU Translations coming soon InVera Infusion Device White Paper A brief overview of the InVera Infusion device, presented in a simple document. Read More trending_flat Relevant 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. Read More trending_flat Declaration of Conformity Declaration of Conformity and translations coming soon.

Slide Meet The InVera Medical Leadership Team Board of Directors Co-Founders Stephen Cox Stephen
Cox CEO, Executive Director Nigel Phelan Dr. Nigel
Phelan CMO, Executive Director Sean Cummins CTO, Executive Director Bernard Lyons Bernard
Lyons Board
Chairperson Masahiro Tanikawa, Board Member, Nipro Corporation Masahiro
Tanikawa Board Member Nipro Corporation Geraldine McLoughlin Geraldine McLoughlin Board Observer WDC Dr. Lowell Kabnick Clinical Operations Consultant
(Head of MAB) Paul Gilson Paul
Gilson External
Advisor

Slide 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.

Current open positions are:

  • Senior Quality Assurance Engineer

  • Director of Quality Assurance & Regulatory Affairs


    • 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.

    Slide Supported By EIC Logo EIT Health Accelerated By BioInnovate Ireland

    Slide FDA InVera Medical Receives FDA Clearance for InVera Infusion Device - a Novel Non-Thermal Catheter for Enhanced Infusion of Sclerosant for Chronic Venous Disease. Read More Slide CE Mark InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device Read More Slide AOS promotion InVera Medical Announces Promotion of Dr. Aisling O’Sullivan to Vice President for Quality Assurance and Regulatory Affairs Read More Slide JP Morgan InVera Medical Seizes Momentum at JPM Healthcare Conference 2024, Anticipating a Year of Healthcare Transformation Read More Slide DTIF Announcement InVera Medical Launches Groundbreaking €4.6 million BioVAS DTIF Project: Pioneering Advances in Microvascular Vessel Intervention for Venous Leg Ulceration. Read More Slide VEITH Exciting News from InVera Medical at VEITH Symposium! Read More Slide Venous publication InVera Medical feature in the latest American Venous Forum | AVF Vein Specialist Newsletter on Emerging Technology Read More Slide UIP 2023 Key Opinion Leader Lowell Kabnick MD presents InVera Medical’s latest updates during the Emerging Technology and Global Abstracts sessions at UIP 2023. Read More Slide LSI Europe 2023 InVera Medical present at LSI Europe 23 Read More Slide Think Business Article InVera Medical named among Ireland’s breakthrough medical and life sciences innovators. Read More Slide ISO 13485 annoucement InVera Medical awarded ISO 13485:2016 certification by BSI for the design, development, and manufacture of sterile ablation catheters for chronic venous disease. Read More Slide Medtech Strategist SC InVera Medical CEO Stephen Cox joins “The Future of Medtech” panel at MedTech Strategist Innovation Summit Dublin 2023 Read More Slide LSI USA 2023 InVera Medical CEO, Stephen Cox presents at LSI USA (March 2023) Watch Stephen's Pitch Back here Slide Medtech Rising 2022 Awards InVera Medical announced as a Finalist for Emerging Medtech Company of the Year Award as part of the Irish Medtech Awards 2022 Read More Slide Silicon Republic Article InVera Medical named among 15 start-ups in Europe shaking up the future of healthcare Read More Slide Business Post 17m InVera Medical targets €17m ‘game-changer’ funding for device to treat varicose veins (Business Post, Aug 2022) Read More Slide EIC Funding Announcement InVera Medical among four Irish companies funded from highly competitive Horizon Europe EIC accelerator Read More Slide Pre-Clinical Data Venari Medical announces publication of pre-clinical data in leading scientific journal Phlebology and changes name to InVera Medical™ Read More Slide Galway Medtech Silicon Republic InVera Medical™: Galway medtech with a potentially life-changing device (Silicon Republic, May 2021) Read More Slide 5.3m funding InVera Medical™ secures $5.3 million investment to advance the Minimally Invasive Treatment of Chronic Venous Disease Read More Slide Start up article irish times Start-up makes breakthrough in treatment for chronic venous disease
    (Irish Times, Jan 2020)     Read More     Slide Medtech Strategist 2019 Venous Devices Come into Their Own (Medtech Strategist, October 2019) Read More Slide Seedcorn 2019 Connacht & Leinster Seedcorn Regional Winner Announced (2019) Read More Slide Medtech Innovator 2019 MedTech Innovator announces five finalists in competition (Medical Design & Outsourcing, Sept 2019) Read More Slide TMC X 2019 Introducing the TMCx09 Medical Device Cohort Companies (TMC Innovation, July 2019) Read More Slide Big Ideas Nigel Enterprise Ireland Big Ideas Showcase - InVera Medical™ (June 2019) Watch Nigel's Pitch Here Slide Medical Device Outsourcing Article 50 medtech startups you need to know (Medical Design & Outsourcing, June 2019) Read More Slide Irish Examiner Article Firm battles venous disease and ulcers (Irish Examiner, November 2018) Read More     InVera Medical News

    Slide Get in Touch
    with us     The InVera Infusion device has received FDA 510(k) clearance in the United States and CE Mark approval from BSI (NB 2797) under MDR 2017/745 for use in the European Union. It is authorised for commercial sale in the US and EU in accordance with its approved indications and remains investigational in all other territories.     How to find us InVera Medical Limited
    Unit 113 Innovation Hub
    Dublin Road
    Galway, Ireland
    H91 DCH9

    Slide email