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The Aptyx team is heading to LSI Europe ’26, and we spent some time with the attendee list before packing. These ten interventional device companies are making waves right now, with new clearances, pivotal data, and first-in-human results worth tracking.
LSI Europe brings together the medtech companies defining the next decade of care, from first-in-human startups to the strategics that will eventually acquire them. For our Interventional Systems team, it is one of the best rooms of the year: catheter-based innovation is everywhere on the agenda, and much of it is moving fast.
Ahead of the meeting, we picked ten companies from the innovator roster whose recent momentum stood out. The common thread is real, dated progress: an FDA clearance, a pivotal readout, a CE Mark, a grant won against long odds, a trial that just opened. The list is unranked, and the milestones below are drawn from public sources including FDA databases, ClinicalTrials.gov, and company announcements.
Galway, Ireland / Stroke Thrombectomy
Perfuze
Perfuze develops the Millipede family of super-bore aspiration catheters for mechanical thrombectomy in acute ischemic stroke. Its flagship Millipede88 pairs a corrugated catheter architecture with a highly flexible, kink-resistant shaft, built around a simple goal: navigate to the clot and remove it in a single pass, without a stent retriever.
The company’s momentum this year has been hard to miss. In March 2026 it received FDA 510(k) clearance for Millipede88, which Perfuze describes as the first 088 super-bore aspiration catheter cleared for standalone direct aspiration, and began a limited US release at comprehensive stroke centers. In August 2026 it published final results from its MARRS pivotal study in the Journal of NeuroInterventional Surgery: a 75 percent first-pass mTICI 2c-3 rate in M1 occlusions and 89 percent mTICI 2b-3 without rescue therapy. The device has carried a CE Mark since 2021, and the program was backed early by a Horizon 2020 grant.
Aspiration-first techniques keep gaining share in stroke intervention, and super-bore catheters are the leading edge of that shift. Perfuze is arriving at exactly the right moment with clinical evidence in hand.
Barcelona, Spain / Stroke Thrombectomy
Anaconda Biomed
Anaconda Biomed, based in Sant Quirze del Vallès outside Barcelona, develops the ANA5 funnel catheter, a self-expanding funnel-tipped access catheter that locally restricts blood flow and maximizes clot capture during stent-retriever thrombectomy. A companion stent retriever, CONDA, is also in the clinic.
ANA5 earned its CE Mark in June 2025 and is now commercially available in Europe. In the US, the company holds an FDA IDE and is recruiting ATHENA, a randomized 327-patient pivotal trial that enrolled its first American patient at Mount Sinai in April 2025. A second study, ARTEMIS, opened in October 2025 to evaluate the CONDA stent retriever.
First-pass success is one of the strongest outcome drivers in thrombectomy, and mechanical adjuncts that improve clot capture address it directly. A randomized pivotal of this size will give the approach a definitive test.
Menlo Park, California / Pulmonary Embolism
Endovascular Engineering
Endovascular Engineering, or E2, developed the Hēlo PE Thrombectomy System for acute pulmonary embolism. Hēlo combines a 24F expandable funnel for clot engagement with a 15F profile for crossing the heart, plus aspiration and an internal agitator that remodels clot as it is removed.
E2 closed out 2025 in style. Its ENGULF pivotal cohort finished enrollment in June, delivered a late-breaking presentation at VIVA in November with a 0.95 percent major adverse event rate and a 25.1 percent reduction in RV/LV ratio, and received FDA 510(k) clearance for Hēlo on December 18, 2025 for removal of emboli and thrombi from the pulmonary arteries and venous vasculature. The program traces its roots to an NIH SBIR grant for its vortex catheter technology.
PE thrombectomy is becoming a race on procedural efficiency and safety rather than raw novelty. A newly cleared system with sub-1-percent major adverse events in its pivotal cohort makes E2 a serious entrant.
Charlottesville, Virginia / Pulmonary Embolism
Liquet Medical
Liquet Medical develops the Versus Catheter, a dual-tip telescoping infusion catheter with integrated real-time pulmonary artery pressure monitoring for catheter-directed thrombolysis in pulmonary embolism. The idea is what the company calls hemodynamic-guided thrombolysis: treat both lungs with a single device while watching the patient’s physiologic response live.
The platform is now FDA-cleared twice over. Versus earned its first 510(k) in November 2024 and entered commercial release weeks later; a second clearance followed in February 2026, adding an interventional radiology configuration and expanding the platform’s pulmonary artery pressure measurement capability. The company, founded around technology from vascular surgeon Dr. Patrick Kelly, has announced plans for a US IDE trial in pulmonary embolism.
PE treatment is shifting toward faster, physiology-guided therapy, and a lean team collecting two clearances in fifteen months is moving at a pace worth watching.
Paris, France & Munich, Germany / Structural Heart
TRiCares
TRiCares is developing Topaz, a transfemoral transcatheter tricuspid valve replacement system. Its dual-stent, self-expanding bioprosthesis is designed to eliminate tricuspid regurgitation entirely rather than reduce it, delivered without open-heart surgery in a patient population that is largely too frail to tolerate one.
In April 2026 the company received FDA IDE approval for TRICURE US, a randomized pivotal trial planned for up to 75 sites across the US, Canada, and Europe, with enrollment slated to begin in October 2026. It runs alongside an ongoing US early feasibility study and a European pivotal, both recruiting since 2024, and a first-in-human study that has followed patients since 2022. The program’s early development was supported by Horizon 2020.
Severe tricuspid regurgitation affects hundreds of thousands of patients in Europe alone, and replacement is emerging as the definitive answer where repair falls short. Topaz entering a randomized US pivotal puts TRiCares at the front of that wave.
Paris, France / Structural Heart
HighLife Medical
HighLife develops a transfemoral, transseptal transcatheter mitral valve replacement system built on a two-component valve-in-ring design, for patients with severe mitral regurgitation who are not candidates for surgery or edge-to-edge repair.
2026 is the year it has come together. The HighLife TMVR System received its CE Mark in January 2026, covering native mitral annulus sizes from 30 to 53 mm, and a phased European commercial rollout is underway. A second CE Mark followed in August 2026 for Clarity, the system’s next-generation valve. The FDA granted the platform Breakthrough Device Designation in April 2025, and the clinical program spans a US early feasibility study, a multi-country expanded study, and a 240-patient Clarity pivotal.
Mitral regurgitation is among the most common valvular heart diseases, and most patients with severe MR still have no replacement option short of surgery. A CE-marked TMVR entering commercial use is a genuine milestone for structural heart.
Tel Aviv Area, Israel / Structural Heart
Append Medical
Append Medical is developing the Append System, an implant-free approach to left atrial appendage closure for stroke prevention in atrial fibrillation. Instead of leaving a permanent occluder in the heart, the system draws the appendage into the left atrium with a vacuum-based transseptal catheter and closes it with a standard surgical suture, leaving nothing behind.
The company crossed into the clinic this spring. Its Applause Study I early feasibility study began enrolling in April 2026 at US sites including Cedars-Sinai, with Dr. Vivek Reddy of Mount Sinai as principal investigator, building on peer-reviewed preclinical work published in May 2026. Industry veteran Shlomi Nachman, formerly of Johnson and Johnson, joined as chairman in 2025.
LAA occlusion is one of the fastest-growing structural heart segments, and device-related thrombus around permanent implants is its best-known weak point. An approach that leaves no implant at all speaks directly to that.
Winchester, United Kingdom / Structural Heart
Heart Biotech
Heart Biotech is developing the Yacoub Heart Valve, a cell-free bioabsorbable nano-fibre scaffold designed to regenerate a living heart valve in place. The scaffold triggers the body’s own healing response and gradually dissolves as the patient’s tissue forms a new valve. It is the brainchild of pioneering cardiothoracic surgeon Prof Sir Magdi Yacoub, the company’s founder and chief scientist, with medtech veteran Francis White as CEO.
Innovate UK has now backed the technology twice, first in January 2025 and again with a 500,000 pound Smart grant announced in July 2025, an award the company notes only around two percent of applicants win. The team is pursuing a US FDA Investigational Device Exemption, with an initial human trial of roughly 50 patients planned to follow.
Every valve on the market today forces a trade-off between lifelong anticoagulation and limited durability. A valve that regenerates and lives with the patient would change that calculus, and few names carry more weight in valve science than Yacoub.
Tel Aviv, Israel / Aortic Intervention
Endoron Medical
Endoron Medical develops Aortoseal, a catheter-based endostapling system that deploys six circumferential nitinol staples in a single action to seal and fix EVAR stent grafts to the aortic wall, recreating the security of a hand-sewn surgical anastomosis for aneurysm patients with hostile neck anatomy. A second program, Aortodock, targets valve anchoring for TAVR in low-calcium anatomies.
The SEAL early feasibility study has been recruiting under an FDA IDE since February 2024, and January 2026 brought the program’s first peer-reviewed clinical case report: a technically successful Aortoseal procedure with complete aneurysm exclusion and no endoleaks at one-month follow-up. The company is backed by a 2.5 million euro EIC Accelerator grant from the European Commission.
Up to half of EVAR candidates present neck anatomy outside device instructions for use, and type Ia endoleaks remain the leading driver of reintervention. Endograft fixation sits squarely in that gap.
Miramar, Florida / Neurovascular
Prometheus Therapeutics
Prometheus Therapeutics is an early-stage neurovascular company developing endovascular photobiomodulation, a catheter-delivered light therapy designed to stimulate the vessel’s own regenerative response and accelerate complete healing of brain aneurysms treated with flow diverters. It pairs two long-standing figures in neurointervention: CEO Dr. Ajay Wakhloo and president and chief scientific officer Dr. Baruch Lieber.
The company published preclinical results in Stroke: Vascular and Interventional Neurology in 2025 showing accelerated complete aneurysm healing alongside flow diverters, following earlier presentations at neurointerventional meetings, and was selected to pitch at the MedTech Innovator 2025 accelerator from a field of more than 1,400 applicants.
Flow diverters transformed aneurysm care, but a meaningful share of treated aneurysms never fully occlude. An adjunct that finishes the job addresses one of neurovascular’s quietest unmet needs.
Also on our radar
The attendee list runs deep this year. A few more companies whose recent milestones caught our eye:
- Jupiter Endovascular (Menlo Park): met both primary endpoints in its SPIRARE II pulmonary embolectomy pivotal at EuroPCR 2026 and took full-system FDA clearance for its Vertex platform in August 2026.
- Innova Vascular (Irvine): FDA-cleared Laguna and Malibu thrombectomy systems, a Varian distribution partnership, and a PE trial recruiting.
- Argá Medtech (Lausanne area): single-catheter pulsed field ablation with first-in-human BURST-AF results at AF Symposium 2026 and a US IDE study recruiting.
- Gradient Denervation Technologies (Paris): FDA Breakthrough-designated ultrasound pulmonary artery denervation for Group 2 pulmonary hypertension, recruiting in its PreVail-PH2 study.
- InterShunt Technologies (Minneapolis): implant-free interatrial shunt for heart failure, enrolling its EASE HF2 US early feasibility study.
- Echopoint Medical (London): fibre-optic iKOr microcatheter measuring FFR, CFR, and IMR from a single device, with first-in-human complete and US clearance targeted for 2027.
See you at LSI Europe
Ten companies, ten different procedures, one pattern: catheter-based and interventional therapies moving into indications that surgery and drugs have not solved. That is the part of medtech we spend every day in, and it is why LSI Europe is circled on our calendar.
The Aptyx Interventional Systems team will be at LSI Europe ’26. If you are building a complex catheter, a delivery system, or a structural heart implant and want to talk development and manufacturing, come find us.
