Drug-Coated Balloon Catheter PAD Restenosis Patents 2026
Drug-Coated Balloon Catheter PAD Restenosis Patents
Drug-coated balloon catheters deliver antiproliferative agents directly to vessel walls during angioplasty, targeting the primary failure mode in peripheral arterial disease treatment. This dataset spans 1999–2025 across coating chemistry, catheter architecture, and clinical application domains.
DCB Catheter Innovation in Peripheral Arterial Disease
Drug-coated balloon (DCB) catheters combine a standard angioplasty balloon with an antiproliferative surface coating, typically paclitaxel at 2–6 µg/mm² surface density, transferred to the vessel wall during a 30–180 second inflation window. The drug inhibits vascular smooth muscle cell proliferation and neointimal hyperplasia, the primary cellular driver of post-angioplasty restenosis.
PAD affects an estimated 8 million Americans and drives approximately 700,000 annual interventional procedures in the US and Western Europe. The imperative to prevent restenosis — the primary failure mode of percutaneous transluminal angioplasty — has made DCB technology one of the most actively innovated fields in vascular medicine, with filings spanning 1999–2025 in this dataset.
Three primary technology sub-domains are represented in this dataset: drug selection and dose optimization (paclitaxel 2–6 µg/mm² and sirolimus alternatives), excipient and coating matrix engineering (shellac, iopromide, urea, citrate esters, PVA-PEG copolymers, biodegradable natural polymers), and catheter architecture design including conical balloon geometries, scoring/cutting balloon integration, and tube-based point-of-care coating assemblies.
Among retrieved records in this dataset, 8 distinct assignees are identifiable with active or pending IP across multiple jurisdictions. Spectranetics LLC holds the highest multi-jurisdictional active patent count in this dataset, with 5 active US patents spanning 2015–2019, all deriving from a single 2010 PCT/EP priority. Dominant jurisdictions are US, EP, WO, and IN.
Coating Technology Clusters and Filing Trends
Within this dataset, four principal technology clusters are identifiable across DCB catheter innovation. Filing activity spans from 1999 exploratory work through 2025 academic and startup entrants, with the highest commercial filing density concentrated in 2010–2019.
Patent Counts by Technology Cluster — DCB PAD (Dataset Snapshot)
Paclitaxel-based coatings with organic excipient matrices represent the largest cluster in this dataset, with catheter geometry innovations and polymer top-coat architectures emerging as secondary clusters.
↗ Click bars to exploreDCB PAD Patent Filing Activity by Era — Retrieved Records
Filing activity in this dataset is most concentrated in the 2010–2019 commercial growth era, with 2020–2025 showing continued activity from new entrants including academic institutions and non-vascular applicants.
↗ Click bars to exploreKey Clinical Applications of DCB Catheter Technology
DCB catheter technology has been validated across multiple clinical domains within this dataset, from large randomized trials in femoropopliteal PAD to emerging non-vascular applications. The following domains represent the principal treatment areas covered in retrieved patent and literature records.
Femoropopliteal Peripheral Arterial Disease
The SFA and popliteal artery represent the dominant application domain across the dataset, supported by the IN.PACT Global Study (1,535 patients, 64 international sites) and the EffPac 5-year RCT using the Luminor® 35 DCB. The COMPARE trial directly compared IN.PACT (3.5 µg/mm²) versus Ranger (2.0 µg/mm²) DCBs in 414 femoropopliteal patients, with long-lesion treatment validated in a 96-patient, 117-limb study.
Primary VascularFemoropopliteal In-Stent Restenosis
Meta-analysis data covering 599 participants across 5 studies documents DCB superiority over plain old balloon angioplasty (POBA) at 12 months, with patency RR 2.38 and TLR freedom RR 1.56. The Tosaka Class III complete ISR subgroup and AV shunt restenosis are specifically addressed, the latter by Acotec Scientific’s conical DCB family (EP 2018 active, IN 2018 and IN 2023 active).
In-Stent RestenosisBelow-Knee and Critical Limb Ischemia
Single-center real-world registry data covering 75 patients including Rutherford grades III–V confirm DCB utility across a broad PAD severity spectrum, with significant ankle-brachial index improvement reported. Critical limb-threatening ischemia (CLTI) patients comprised 24.8% of the multiple-DCB long-lesion cohort studied in retrieved literature.
Critical Limb IschemiaNon-Vascular Body Lumen Applications
Urotronic Inc. holds active EP (2024) and US (2024, 2025) patents for DCB catheters addressing urethral strictures, benign prostatic hyperplasia, and urologic lumen stenoses using paclitaxel with pentaerythritol ethoxylate/propoxylate excipients. Airiver Medical filed a US pending application (November 2025) for airway DCB methods covering paclitaxel and sirolimus coatings at 1–20 µg/mm² for central airway obstruction.
Non-Vascular DCBKey Patent Assignees in DCB Catheter Technology (Retrieved Records)
In retrieved records within this dataset, Spectranetics LLC holds the highest multi-jurisdictional active patent count with 5 active US patents (2015–2019) from a single 2010 PCT/EP priority, while EuroCor GmbH/Tech GmbH holds foundational shellac-paclitaxel coating IP across WO, EP, and multiple US grants. Eight named assignees are identifiable in this dataset spanning US, German, Polish, Chinese, and Italian jurisdictions.
Top Assignees by Patent Count — DCB PAD (Dataset Snapshot)
↗ Click bars to exploreSpectranetics LLC
Spectranetics holds 5 active US patents (2015–2019) and 1 active EP patent, all deriving from a single 2010 PCT/EP priority, covering coating formulations for scoring and cutting balloon catheters and a dual-agent balloon carrying both antiproliferative and vascular healing–promoting drugs simultaneously. The company was acquired by Philips in 2017 in a major industry consolidation event. Patent US 2017 (“Balloon Angioplasty Catheter Coating to Encourage Vessel Repair”) represents the dual-agent technology claim anchor.
United StatesEuroCor GmbH / EuroCor Tech GmbH
EuroCor holds foundational shellac-paclitaxel coating patents across WO (2010), EP (2010 inactive, 2016 active via Biosensors Europe), and multiple active US grants (2012 and 2019), establishing shellac as a biodegradable carrier enabling effective paclitaxel tissue transfer after 30-second balloon inflation. The IP family is one of the most commercially impactful in this dataset, demonstrating superiority over pure-paclitaxel coatings for late lumen loss reduction. An additional 2019 US continuation (EuroCor Tech GmbH) remains active.
GermanyNext-Generation DCB Technologies and Expansion Vectors
Based on filings and literature from 2022–2025 in this dataset, five clear emerging directions are identifiable: sirolimus DCBs as paclitaxel alternatives, high-dose paclitaxel formulation engineering, point-of-care in-situ coating systems, non-vascular DCB expansion, and nanoparticle bioactive peptide coating matrices.
Sirolimus-Coated Balloons as Paclitaxel Alternatives
The 2018 Katsanos meta-analysis mortality signal for paclitaxel-coated devices catalyzed intensive development of sirolimus DCBs (SCBs). A 2022 literature review documents SCBs achieving good 12-month patency in PAD with no major adverse events, with several SCBs CE-marked and commercially available in Europe and Asia. The SCORE trial protocol (2023) for crystalline sirolimus-coated balloons (cSCBs) in an all-comers coronary population represents the next phase of clinical validation with technology transferable to peripheral indications.
High-Dose Paclitaxel Formulation at 6 µg/mm²
A 2021 preclinical study demonstrated that a novel 6 µg/mm² DCB using a modified iopromide matrix delivered approximately twice the paclitaxel tissue concentration versus standard 3 µg/mm² devices (1,957 ± 1,472 µg/g vs. 787 ± 738 µg/g, p=0.017), without requiring proportionate double-balloon overlap. This signals a shift toward concentration-optimized single-balloon deployment for complex lesions, potentially reducing procedure complexity while maintaining therapeutic drug levels.
Paclitaxel vs. Sirolimus Drug-Coated Balloon Platforms
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| Dimension | Paclitaxel DCB | Sirolimus DCB (SCB) |
|---|---|---|
| Drug Mechanism | Inhibits microtubule depolymerization; blocks VSMC proliferation in G2/M phase | mTOR pathway inhibition; blocks VSMC proliferation in G1 phase |
| Typical Dose Density | 2–6 µg/mm² (commercial range); 3.5 µg/mm² IN.PACT Admiral; 2.0 µg/mm² Ranger/Stellarex | Not specified in dataset for peripheral DCB; 1–20 µg/mm² for airway DCB (Airiver Medical) |
| Excipient/Carrier Examples | Shellac (EuroCor), iopromide, urea, citrate ester (Hemoteq), PVA-PEG (Cardionovum) | Crystalline sirolimus micro-reservoir format; pentaerythritol ethoxylate/propoxylate (Urotronic, non-vascular) |
| Clinical Evidence (PAD) | IN.PACT Global (1,535 pts), EffPac 5-yr RCT, ILLUMENATE European RCT, COMPARE trial (414 pts) | 2022 review: good 12-month patency, no major adverse events; CE-marked products available in Europe/Asia |
| Regulatory/Safety Context | 2018 Katsanos meta-analysis raised mortality signal; ongoing regulatory scrutiny in peripheral indications | No mortality signal identified in dataset; increasing CE-mark approvals in Europe and Asia |
| Key Patent Assignees | Spectranetics LLC, EuroCor GmbH, Hemoteq AG, Cardionovum GmbH, Acotec Scientific, Invatec | SCORE trial (cSCB); Airiver Medical (airway, US 2025 pending); no dedicated SCB assignees in this dataset |
| Commercial Status | Multiple commercially approved products (IN.PACT Admiral, Luminor 35, Ranger, Stellarex) with long-term data | Several CE-marked SCBs commercially available in Europe and Asia per 2022 literature review |
Frequently Asked Questions: DCB Catheter PAD Restenosis Patents
Paclitaxel is the most common drug in this dataset, used at surface densities of 2–6 µg/mm². Commercial platforms include IN.PACT Admiral at 3.5 µg/mm² and Ranger/Stellarex at 2.0 µg/mm². Sirolimus-based formulations are an emerging alternative following the 2018 Katsanos meta-analysis mortality signal associated with paclitaxel devices.
Spectranetics LLC holds the highest multi-jurisdictional active patent count in this dataset, with 5 active US patents spanning 2015–2019 and 1 active EP patent, all deriving from a single 2010 PCT/EP priority. Spectranetics was acquired by Philips in 2017.
The dataset identifies multiple excipient systems: shellac (EuroCor GmbH, biodegradable carrier enabling 30-second transfer), citrate esters and urea (Hemoteq AG, molecular dispersant system), iopromide (used in experimental 6 µg/mm² high-dose formulations), PVA-PEG graft copolymers (Cardionovum GmbH, protective top-coat), and pentaerythritol ethoxylate/propoxylate (Urotronic Inc., non-vascular DCB).
The IN.PACT Global Study enrolled 1,535 patients across 64 international sites. The EffPac trial reported 5-year results for the Luminor® 35 DCB. The COMPARE trial enrolled 414 patients comparing high-dose (3.5 µg/mm²) versus low-dose (2.0 µg/mm²) DCBs. The ILLUMENATE European RCT reported 1-year results in 2017. For in-stent restenosis, a meta-analysis of 599 participants across 5 studies showed DCB patency RR 2.38 over POBA at 12 months.
The most recent filings in this dataset are Wake Forest University Health Sciences’ WO application (March 2025) for a tube-based in-situ balloon coating assembly, Urotronic Inc.’s US applications (2024 and 2025) for non-vascular DCB catheters, Airiver Medical Inc.’s US pending application (November 2025) for airway DCB methods, and Acotec Scientific Co. Ltd.’s IN continuation grant (2023) for its conical AV shunt DCB design.
The Acotec Scientific conical DCB (WO 2017, EP 2018 active, US 2018, IN 2018 and 2023 active) uses an axis-symmetrical balloon with an increasing diameter from proximal to distal end, specifically optimized for tapered vessel geometries in arteriovenous hemodialysis access shunt restenosis. This hardware architecture innovation was filed across 4 jurisdictions, signaling sustained Chinese assignee engagement in both device design and international IP strategy.
Data and insights on this page are based on a limited patent and literature dataset and are for reference only. Figures may not represent the complete technology landscape.