DCT

1:26-cv-00469

Angiodynamics Inc v. Endovascular Engineering Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00469, D. Del., 06/11/2026
  • Venue Allegations: Venue is asserted on the basis that both Plaintiff and Defendant are Delaware corporations, and therefore Defendant resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant's Hēlo Thrombectomy System infringes five U.S. patents related to catheter-based thrombectomy devices featuring self-expanding funnels for blood clot removal.
  • Technical Context: The technology involves minimally invasive catheter systems designed to remove blood clots from the circulatory system, providing a significant alternative to more invasive procedures like open-heart surgery for conditions such as pulmonary embolism.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with pre-suit notice of infringement via a series of letters beginning in March 2024. It further alleges that Defendant's founder and key personnel were aware of Plaintiff's patents, having cited them as prior art in Defendant's own patent applications, and that Defendant has invoked the 35 U.S.C. § 271(e)(1) "safe harbor" defense for activities related to regulatory submissions.

Case Timeline

Date Event
2007-12-20 Priority Date for '717, '880, and '714 Patents
2013-12-24 U.S. Patent No. 8,613,717 Issues
2015-10-16 Priority Date for '077 and '162 Patents
2023-02-28 U.S. Patent No. 11,589,880 Issues
2024-03-07 Plaintiff allegedly sends first notice letter to Defendant
2024-06-05 Plaintiff allegedly sends follow-up letter with claim chart for '880 Patent
2025-12-18 FDA clears Defendant's Hēlo system for treating pulmonary embolism
2025-12-19 Plaintiff allegedly sends notice letter regarding newly issued '077 Patent
2025-12-16 U.S. Patent No. 12,496,077 Issues
2026-04-01 Defendant is allegedly "commercial-stage" (approx. date)
2026-05-12 U.S. Patent No. 12,622,714 Issues
2026-05-19 U.S. Patent No. 12,629,162 Issues
2026-06-11 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,613,717 - "SYSTEMS AND METHODS FOR REMOVING AND FRAGMENTING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM"

  • Patent Identification: U.S. Patent No. 8,613,717, "SYSTEMS AND METHODS FOR REMOVING AND FRAGMENTING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM," issued December 24, 2013.

The Invention Explained

  • Problem Addressed: The patent's background describes the significant risks and limitations of contemporary treatments for blood clots in large vessels Compl. ¶7 It notes that biologic agents (thrombolytics) carry a high risk of bleeding, while existing mechanical catheter-based options are often ineffective, and open surgery is highly invasive '717 Patent, col. 3:5-10 '717 Patent, col. 4:1-5
  • The Patented Solution: The invention provides a system for removing undesirable material like blood clots "substantially en bloc" using a cannula, while simultaneously reinfusing the patient's filtered blood to minimize blood loss '717 Patent, abstract A key aspect is the inclusion of a "fragmentation device" to break up the captured material, enhancing its removal through the cannula '717 Patent, col. 5:42-50
  • Technical Importance: This technology provided a less invasive method for mechanically removing large clots, aiming to combine the effectiveness of surgery with the reduced trauma of a catheter-based procedure Compl. ¶8

Key Claims at a Glance

  • The complaint asserts at least independent claim 15 Compl. ¶88
  • Essential elements of Claim 15 (a system claim) include:
    • A first cannula for removing undesirable material.
    • A powered fragmentation device to break up the material.
    • A second cannula to reinfuse fluid.
    • A pump to provide suction and drive reinfusion.
    • A filter device to separate the undesirable material from the fluid.
  • The complaint reserves the right to assert other claims Compl. ¶87

U.S. Patent No. 11,589,880 - "SYSTEM AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM UTILIZING DURING A SURGICAL PROCEDURE"

  • Patent Identification: U.S. Patent No. 11,589,880, "SYSTEM AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM UTILIZING DURING A SURGICAL PROCEDURE," issued February 28, 2023.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of effectively capturing and removing large, organized blood clots from medium-to-large blood vessels and heart chambers without resorting to highly invasive surgery '880 Patent, col. 1:33-40 '880 Patent, col. 4:58-67
  • The Patented Solution: The patent describes a device with a cannula that has a deployable, funnel-shaped distal end '880 Patent, abstract This funnel, which can be expanded from a compressed state (e.g., by retracting a sheath), creates a larger capture area, improving the ability to remove material "substantially en bloc" '880 Patent, col. 8:35-43 '880 Patent, col. 9:1-8 The design aims to generate a "vortex flow" to help direct the material into the cannula '880 Patent, col. 8:50-59
  • Technical Importance: The self-expanding funnel represented a key innovation for enabling effective, minimally invasive thrombectomy in large vessels Compl. ¶9

Key Claims at a Glance

  • The complaint asserts at least independent claims 1 and 12 Compl. ¶98
  • Essential elements of Claim 1 (a device claim) include:
    • A cannula with a distal end, a lumen, and a proximal end.
    • The distal end comprises at least two strips, a space between the strips, and a membrane extending across the space.
    • The proximal end is configured to couple to a vacuum source.
  • The complaint reserves the right to assert other claims Compl. ¶97

U.S. Patent No. 12,496,077 - "SYSTEMS AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM"

  • Patent Identification: U.S. Patent No. 12,496,077, "SYSTEMS AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM," issued December 16, 2025 Compl. ¶31

Technology Synopsis

The '077 Patent discloses an aspiration cannula with an expandable funnel defined by a unitary metallic reinforcement frame made of a shape memory material. This design allows the funnel to automatically expand to a pre-shaped configuration when released from a constraint (such as an outer sheath) while being robust enough to resist collapse under vacuum '077 Patent, claim 1

Asserted Claims

At least claims 1, 9, and 14 are asserted Compl. ¶108

Accused Features

The Hēlo system's self-expanding funnel technology is accused of infringement Compl. ¶66

U.S. Patent No. 12,622,714 - "SYSTEMS AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM DURING A SURGICAL PROCEDURE"

  • Patent Identification: U.S. Patent No. 12,622,714, "SYSTEMS AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM DURING A SURGICAL PROCEDURE," issued May 12, 2026 Compl. ¶37

Technology Synopsis

The '714 Patent focuses on an integrated system for aspirating and filtering material from the vasculature. It claims a system including a cannula with a funnel-shaped distal end, a pump, and a specific filter assembly that includes a venting aperture to displace air from the system '714 Patent, claim 1 This configuration aims to improve the efficiency and safety of the closed-loop aspiration and filtration process.

Asserted Claims

At least claim 1 is asserted Compl. ¶118

Accused Features

The Hēlo system as a whole, including its pump and blood/clot collecting components, is accused of infringement Compl. ¶44

U.S. Patent No. 12,629,162 - "SYSTEMS AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM"

  • Patent Identification: U.S. Patent No. 12,629,162, "SYSTEMS AND METHODS FOR REMOVING UNDESIRABLE MATERIAL WITHIN A CIRCULATORY SYSTEM," issued May 19, 2026 Compl. ¶34

Technology Synopsis

The '162 Patent describes a thrombectomy device comprising an aspiration cannula with an expandable funnel and an outer sheath, where the cannula can move coaxially within the sheath. The funnel structure includes a polymer jacket and a pre-shaped metallic reinforcement member that automatically expands when released from the sheath's constraint '162 Patent, claim 1 The invention centers on the specific construction and interaction of the cannula and its deployment sheath.

Asserted Claims

At least claim 1 is asserted Compl. ¶128

Accused Features

The Hēlo system's aspiration catheter and its associated self-expanding funnel mechanism are accused of infringement Compl. ¶44 Compl. ¶66

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the Hēlo Thrombectomy System, which includes components such as an Aspiration Catheter, Agitator, Rotating Hemostatic Valve, Pump, and Blood/Clot Collecting Device Compl. ¶44

Functionality and Market Context

  • The complaint alleges the Hēlo system is a "vacuum catheter with a self-expanding funnel tip" designed to remove blood clots Compl. ¶14 It has received FDA clearance for treating pulmonary embolisms and for the non-surgical removal of clots from peripheral veins Compl. ¶14 The complaint provides an image from Defendant's materials showing a "24 Fr self-expanding Funnel" with a mesh-like structure Compl. p. 21 Plaintiff positions the Hēlo system as a direct copy of its own AngioVac and AlphaVac products and alleges it is being launched by a well-funded, "commercial-stage" company, presenting a direct competitive threat Compl. ¶16 Compl. ¶66

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that were not provided with the filing. The following analysis is constructed based on the narrative allegations and visual evidence within the complaint.

U.S. Patent No. 8,613,717 Infringement Allegations

Claim Element (from Independent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
a first cannula ... designed for maneuvering within the vessel ... so as to capture ... the undesirable material ... The Hēlo Aspiration Catheter is allegedly designed to be maneuvered within a patient's vasculature to capture and remove blood clots. ¶44 col. 21:50-57
a powered fragmentation device in coaxial alignment with the first cannula to break up the undesirable material The Hēlo system is alleged to include an "Agitator." ¶44 col. 21:58-61
a second cannula ... to reinfuse fluid removed ... back into the patient The Hēlo system is alleged to have "workflow-integrated blood return" functionality. p. 21 col. 22:5-9
a pump ... to provide a suction force for removing the undesirable material The Hēlo system is alleged to include a "Pump" to create the vacuum force for aspiration. ¶44 col. 22:10-13
a filter device ... to entrap or capture the undesirable material and remove it from the fluid flow The Hēlo system is alleged to include a "Blood/Clot Collecting Device" for filtration. ¶44 col. 22:14-17

Identified Points of Contention

  • Scope Question: A central issue may be whether the Hēlo system's "Agitator" Compl. ¶44 meets the definition of a "powered fragmentation device." The patent specification discloses a "grate" for this purpose '717 Patent, col. 5:42-45, raising the question of whether the claim term will be construed narrowly to such structures or broadly enough to read on the accused "Agitator."
  • Technical Question: The complaint does not detail the specific mechanism of the "Agitator." The court will require evidence on its precise function to determine if it actually performs fragmentation as required by the claim.

U.S. Patent No. 11,589,880 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a cannula comprising a cannula distal end, a cannula lumen, and a cannula proximal end; The Hēlo Aspiration Catheter is alleged to be a cannula for removing blood clots. ¶44 col. 7:1-3
the cannula distal end comprising at least two strips, a space between the at least two strips, and a membrane extending across the space between each of the at least two strips; The Hēlo system is alleged to have a "self-expanding funnel tip." A marketing image shows a funnel with a mesh-like, stent-like structure. ¶14; p. 21 col. 9:40-49
and the cannula proximal end to operably couple to a vacuum source to create a negative pressure to pull the undesirable material into the cannula lumen. The Hēlo system is described as a "vacuum catheter" and is alleged to include a "Pump" that provides the suction force. ¶14; ¶44 col. 9:60-64

Identified Points of Contention

  • Scope Question: A primary dispute may center on the claim term "membrane extending across the space between each of the at least two strips." The visual evidence of the accused funnel suggests a braided, stent-like structure Compl. p. 21 The analysis will question whether this integrated mesh construction can be read to include distinct "strips" and a "membrane," or if the claim requires separate structural components as depicted in the patent's figures '880 Patent, Fig. 3A
  • Technical Question: Evidence will be needed to determine the actual construction of the accused funnel. The analysis will depend on whether it is a unitary braided structure, a frame with a polymer coating that acts as a membrane, or another configuration.

V. Key Claim Terms for Construction

'717 Patent: "fragmentation device" (from Claim 15)

  • Context and Importance: Infringement of claim 15 of the '717 Patent may turn on whether the Hēlo system's "Agitator" Compl. ¶44 is considered a "fragmentation device." Practitioners may focus on this term because its construction will determine if a component that merely moves or repositions a clot, without necessarily breaking it apart, can satisfy the limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself is not explicitly limited to a particular structure. Plaintiff may argue that any powered component that facilitates the material's passage into the cannula by altering its shape or form, including an "Agitator," meets the functional requirement.
    • Evidence for a Narrower Interpretation: The specification describes the device as breaking the material into "smaller pieces" and provides a specific embodiment of a "grate" '717 Patent, col. 5:42-50 '717 Patent, Fig. 2J Defendant may argue this context limits the term to devices that perform mechanical cutting or breaking, not just agitation.

'880 Patent: "membrane extending across the space between each of the at least two strips" (from Claim 1)

  • Context and Importance: This term is critical because the complaint alleges infringement by the Hēlo system's "self-expanding funnel," and the provided visual suggests a braided mesh structure rather than distinct strips and a separate membrane Compl. p. 21 The case may depend on whether this integrated construction meets the claim's structural requirements.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not narrowly define "membrane" or "strips." Plaintiff could argue that the individual struts of a braided stent constitute the "strips" and that an embedded or coated polymer within the braid constitutes the "membrane extending across the space."
    • Evidence for a Narrower Interpretation: The patent specification includes figures that explicitly depict "strips" (31) and a separate "membrane" (35) as distinct components '880 Patent, Fig. 3A Defendant may argue that this explicit disclosure limits the claim scope to a multi-component structure, and that a unitary braided mesh does not meet the limitation of a membrane "extending across" the space between strips.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges inducement of infringement by Defendant encouraging and instructing hospitals and medical professionals to use the Hēlo system in an infringing manner Compl. ¶92 Compl. ¶102 It also alleges contributory infringement by supplying the Hēlo system components, which are described as a material part of the invention, not suitable for substantial non-infringing use, and especially made for use in an infringing manner Compl. ¶93 Compl. ¶103

Willful Infringement

  • Willfulness is alleged based on both pre- and post-suit knowledge. The complaint asserts Defendant had pre-suit knowledge through a series of notice letters sent by Plaintiff beginning in March 2024 Compl. ¶69 Compl. ¶89 Crucially, it also alleges that Defendant's founder, Dr. Luis Savastano, knew of Plaintiff's technology and cited one of its foundational patents in his own patent application long before the accused product was developed Compl. ¶68 Further allegations of knowledge are based on Defendant's own patents citing Plaintiff's patents as prior art Compl. ¶90 Compl. ¶100

VII. Analyst's Conclusion: Key Questions for the Case

  • A core issue will be one of structural scope: can the claim language of "at least two strips" and a "membrane extending across the space" be construed to read on the integrated, braided-stent-like structure of the accused Hēlo funnel, or does the patent's disclosure require distinct structural components?
  • A second key issue will be one of functional definition: does the accused "Agitator" component perform the function of a "fragmentation device" as required by the '717 patent, or is its function merely to reposition material, creating a potential mismatch in technical operation?
  • The dispute will also likely center on the question of willfulness, with a focus on evidence of pre-suit knowledge. The allegations that Defendant's founder and its own patent filings cited Plaintiff's patents as prior art will be central to determining whether any infringement was objectively reckless.
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