Innovations in catheters and handheld delivery systems are pushing the boundaries of what is possible in interventional and diagnostic procedures. A new generation of start-ups is building minimally invasive devices for conditions that have long meant open surgery, repeated procedures, or very limited treatment options.
This list profiles 10 of the top catheter and handheld delivery system startups in 2026. They are still developing their technologies, but to make our list, they have all reached a significant recent milestone, from first-in-human studies and FDA Breakthrough Device designation to new funding rounds and industry awards.
We researched over 400 companies to come up with our top 10. Together, they span neurosurgery, heart failure, structural heart disease, coronary diagnostics, vascular disease, obesity, and obstetrics.
1. STENTiT (Netherlands)
Chronic limb-threatening ischaemia affects more than 3.5 million people in the EU and US every year. [1] It also leads to around 250,000 amputations a year.[1] Eindhoven-based STENTiT is tackling this condition with a new class of stent that helps the body heal itself.
Its Resorbable Fibrillated Scaffold (RFS) is built from microfibres. Placed in blocked arteries below the knee, it opens the vessel immediately. Its porous structure then lets the patient’s own cells grow and form new vascular tissue. As the artery rebuilds from the inside out, the scaffold gradually dissolves. The aim is to leave the patient’s own rebuilt artery, with no permanent implant behind.[2]
The technology reached a major milestone in June 2025, when the first patient was treated in the VITAL-IT 1 first-in-human study at the Medical University of Graz, Austria.[2] A spin-off from Eindhoven University of Technology,[3] STENTiT was named a MedTech Innovator 2025 finalist.[4]
Sources:
1. https://www.stentit.com/
2. https://en.santelog.com/actualites-sante-nasdaq/stentit-enrolls-first-patient-clinical-trial-evaluating-novel-stent
3. https://siliconcanals.com/stentit-raises-1-8m/
4. https://www.stentit.com/news/
2. Endovascular Horizons (United States)
Chronic subdural haematoma is one of the most common, and growing, conditions in neurosurgery. Treating it has traditionally meant drilling into the skull.[1] Endovascular Horizons is pioneering transvascular neurosurgery to reach the brain through the body’s own blood vessels.[1]
Its EMBODRAIN System is the first fully endovascular solution for the condition.[1] In a single procedure, physicians first embolise the middle meningeal artery, cutting off the blood supply that feeds the haematoma. They then create a controlled micro-channel from the artery into the haematoma to drain it through the same arterial access.[1][3]
Data from the EMBODRAIN study won the Best Abstract Award at SVIN 2025.[2] A 2026 expert consensus from the ARISE roundtable, published in the Journal of NeuroInterventional Surgery, found that first-in-human studies of this combined approach show high technical success, rapid improvement, and no early recurrences.[4]
Founded by UCSF neurosurgeon Dr Luis Savastano, Endovascular Horizons announced plans in late 2025 for a pivotal trial with a view to seeking FDA approval.[2]
Sources
1. https://www.endovascularhorizons.com/
2. https://neuronewsinternational.com/endovascular-horizons-receives-best-abstract-award-for-transvascular-neurosurgery-data-at-svin-2025/
3. https://neuronewsinternational.com/combined-embolisation-drainage-approach-could-be-transformational-next-step-in-endovascular-csdh-treatment/
4. https://jnis.bmj.com/content/early/2026/05/07/jnis-2026-025150
3. Gradient Denervation Technologies (France)
Up to two-thirds of heart failure patients worldwide have pulmonary hypertension. Currently, there are no approved drug or device therapies for the form of the disease that is linked to left heart disease.[1] Paris-based Gradient Denervation Technologies is developing the first purpose-built, minimally invasive, ultrasound-based system to treat it.[1]
The Gradient Denervation System is delivered by catheter to the pulmonary artery. Once there, therapeutic ultrasound ablates the surrounding nerves. The aim of reducing this nerve activity is to lower both vascular resistance and pressure in the lungs.[2]
In 2025, the system received FDA Breakthrough Device designation[2], and it was accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP).[3] The system is being evaluated in the PreVail-PH2 early feasibility study.[2]
Built on technology from the Stanford Biodesign programme, the company is backed by €14M Series A funding led by Asabys Partners, with Sofinnova Partners and Thuja Capital.[4]
Sources
1. https://gradientdenervation.com/
2. https://www.massdevice.com/gradient-fda-breakthrough-pulmonary-artery-denervation/
3. https://gradientdenervation.com/gradient-denervation-technologies-announces-acceptance-into-fdas-total-product-life-cycle-advisory-program-for-development-of-its-pulmonary-artery-denervation-system/
4. https://www.biospace.com/gradient-denervation-technologies-closes-14m-series-a-led-by-sabadell-asabys
4. T-Heart (France)
Clinically relevant tricuspid regurgitation affects more than 4.6 million people across Europe and the US, with over 500,000 new cases diagnosed each year.[1] For many patients, particularly older people, open-heart surgery carries too much risk, while medication only eases the symptoms.[1]
Paris-based T-Heart is developing a one-step transcatheter tricuspid valve replacement system designed and built specifically to address this challenge.[1] Its valve prosthesis features a proprietary anchoring structure that conforms to the enlarged valve ring and restores the native valve to its natural size.[1] The system can be delivered through either the femoral or jugular vein, giving physicians flexibility in how they access the heart.[1]
With five degrees of control, the one-step Delivery System enables interventional cardiologists to replace the diseased valve through a minimally invasive procedure. A small range of device sizes is designed to cover a broad patient population.
Co-founded in late 2018 with iBionext, a Paris-based health-tech company builder, and inventor Dr. Alain Dibie, T-Heart is led by CEO Ella Faktorovich.[1][2]
Sources
1. https://theartvalve.com/
2. https://www.businesswire.com/news/home/20221129005579/en/T-Heart-Appoints-Sarah-Sorrel-as-Independent-Board-Member
5. SonoVascular (United States)
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism, is the third leading cardiovascular disease. It is linked to around 300,000 deaths in the US each year.[1] Chapel Hill-based SonoVascular is developing the SonoThrombectomy System, a new approach to clot removal.[1]
Its catheter delivers ultrasound and microbubbles directly to the clot. As the microbubbles cavitate, they mechanically break the clot apart, helped by a very low dose of clot-dissolving medication. The device is designed for use in a cath lab during a single-session procedure, with no need for ICU care.[1][2]
In the first eight first-in-human DVT cases, presented at the 2025 American Venous Forum, every patient achieved complete clot reduction.[2] In February 2026, SonoVascular closed a $6M Series A funding round led by Harbright Ventures. The funding supports a planned US pivotal study and a first-in-human study in pulmonary embolism.[3]
Sources
1. https://www.sonovascular.com/
2. https://www.prnewswire.com/news-releases/first-in-human-clinical-results-for-sonovasculars-sonothrombectomy-system-presented-at-the-2025-annual-meeting-of-the-american-venous-forum-302402258.html
3. https://www.massdevice.com/sonovascular-6m-series-a-thrombectomy-system/
6. Echopoint Medical (United Kingdom)
Many patients who undergo coronary angiography for stable angina show no blocked arteries. Some, however, have ANOCA, INOCA, or coronary microvascular dysfunction. These conditions are invisible on a standard angiogram but cause ongoing symptoms and repeat hospital visits.[1] London-based Echopoint Medical is closing that diagnostic gap.
Its iKOr optical microcatheter measures fractional flow reserve, coronary flow reserve, and microcirculatory resistance, all from a single device. It runs over a standard coronary guidewire and avoids the saline-bolus steps that have limited the reproducibility of microvascular testing.[1]
A University College London spin-out, Echopoint completed its first-in-human trial at Barts Heart Centre in 2023.[2] In 2026, it closed a $2.5M funding round led by Parkwalk to advance towards FDA submission and a US clinical programme.[3] It is a member of the HeartX cardiovascular accelerator and is preparing the iKoDE study to build real-world evidence in US cath labs.[1]
Sources
1. https://www.echopointmedical.com/tackling-the-anoca-inoca-diagnostic-gap-echopoint-medical-advances-toward-ikode-clinical-study/
2. https://www.ucl.ac.uk/news/2023/feb/first-heart-patients-diagnosed-using-new-fibre-optic-technology
3. https://www.echopointmedical.com/echopoint-medical-close-2-5-million-funding-round/
7. Laguna Tech USA (United States)
Aortic regurgitation is the third most common valvular heart disease, affecting an estimated 4.9 million patients in 2023. However, there are no approved transcatheter devices for the condition in the US. This leaves patients with medication, open-heart surgery, or off-label valves.[1] Irvine-based Laguna Tech USA is developing a valve built for the job.
Its ZETA Transcatheter Aortic Valve System is a balloon-expandable valve designed to treat both aortic regurgitation and aortic stenosis. Six atraumatic arms pin the native leaflets for simple positioning. A low valve height improves coronary clearance, and the delivery system can deflect, rotate, and telescope to handle complex anatomy.[1]
In its first-in-human trial, five patients were treated with ZETA at a single centre in Santiago, Chile, on the same day.[2] The company has also taken its self-expanding Alpha valve into a first-in-human study[3] and presented a ZETA programme update at NY Valves 2026.[4]
Sources
1. https://lagunatechmed.com/
2. https://lagunatechmed.com/laguna-tech-usa-announces-site-record-number-of-transcatheter-heart-valves-implanted-at-single-center-on-same-day-in-first-in-human-clinical-trial/
3. https://lagunatechmed.com/laguna-tech-usa-begins-fih-trial-of-alpha-tavr-system/
4. https://www.tctmd.com/slide/zeta-balloon-expandable-tavr-system-aortic-regurgitation-laguna-tech-program-update
8. Sedivention (Germany)
Obesity is expected to affect more than one billion people worldwide by 2030, with connected global healthcare costs reaching up to $4 trillion a year.[1] Sedivention, based in Munich and Magdeburg, is developing a one-time, minimally invasive treatment that targets what the company sees as the root cause: disrupted hunger and satiety regulation.[1]
A specially designed cryo-balloon catheter is inserted in a similar way to a gastroscopy. It then uses cryoablation to interrupt the gastric branches of the vagus nerve. This is the nerve that carries hunger signals to the brain.[1][2] The procedure is designed to take about 20 minutes in an outpatient setting and leaves nothing behind in the body.[2]
In May 2026, Sedivention closed a €2.9M seed round led by bmp Ventures and the IBG funds. It also has backing from HTGF and the strategic investment arm of a global medtech company. The funding will take its tested prototype into a first-in-human study.[1]
Sources
1. https://www.htgf.de/en/sedivention-seed-financing-round/
2. https://www.sedivention.com/
9. Rhovica Neuroimaging (Switzerland)
External ventricular drain (EVD) placement is one of the most common neurosurgical procedures, and it can be life-saving. However, it is usually performed freehand at the bedside guided only by anatomical landmarks. Misplacement rates are up to 28%.[1] Bern-based Rhovica Neuroimaging, founded by neurosurgeons Dr Martin Hlavica and Dr Thomas Rhomberg, is bringing real-time guidance to the procedure.[1]
Its SoNav system is an EVD catheter with integrated miniaturised ultrasound sensors. The sensors show the brain’s ventricles live, guiding placement without external imaging.[1][2] SoNav is designed to cut placement time by up to 45 minutes. It is also designed to reduce repeated attempts and lower costs by around CHF 2,100 per patient.[2]
In 2025, Rhovica raised CHF 2.3M in a round led by M2care.[3] In 2026, it was named one of three winners of the Ypsomed Innovation Award[2] and won the FutureHealth Basel Innovation Challenge.[4]
Sources
1. https://www.rhovica.com/
2. https://rhovica.com/rhovica-wins-the-ypsomed-innovation-award/
3. https://rhovica.com/rhovica-neuroimaging-secures-chf-2-3m-financing-led-by-m2care/
4. https://rhovica.com/rhovica-neuroimaging-wins-the-futurehealth-basel-innovation-challenge-2026/
10. Induvita (Norway)
Around 30% of pregnancies in Western Europe require labour induction. In Norway, 97% of inductions use a urinary catheter designed for men that is not CE-marked for this purpose.[1] Induvita was founded in 2022 by midwife Hege Hansen and gynaecologist Dr Stine Andreasen to provide obstetrics with purpose-built equipment.[1][2]
Induvita’s Iola Induction Catheter is a single-balloon catheter with a flexible tube, a stylet, and a unique filling unit. Only one person is needed to insert it, opening the way for midwives to place it at the bedside. The flexible tube folds inside the vagina, so women can move freely or even return home, freeing up hospital resources.[3]
In September 2026, Induvita raised NOK 7.5M, bringing its total to NOK 17.9M. The funding supports continued development of Iola and the commercial launch of its redesigned Vega speculum. Its Runa and Ayla training simulators are already available globally.[2]
Sources
1. https://femtechinsider.com/how-medtech-startup-induvita-is-setting-new-standards-in-labor-and-delivery-care-with-a-three-device-strategy/
2. https://femtechinsider.com/induvita-raises-nok-7-5m-to-modernize-gynecological-care/
3. https://www.induvita.no/products/iola-induction-catheter
Support from Arrotek
At Arrotek, we partner with innovators like the startups on this list to take catheter and handheld delivery device concepts from design through to manufacture. Contact us to arrange a discovery call with one of our design engineers.
