# Enhanced Suction Thrombectomy in Pulmonary Embolism Using Vortex Catheter Technology

> **NIH NIH R43** · ENDOVASCULAR ENGINEERING, INC. · 2021 · $298,197

## Abstract

PROJECT SUMMARY
Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States.
Approximately 500,000-600,000 Americans are diagnosed with PE, which causes up to 180,000 death per year.
According to the American Heart Association (AHA), PE is classified into three categories: massive, submassive,
or low risk. Treatment with anticoagulants is the cornerstone for treatment of PE; however, suboptimal results such
as a similar 30-days mortality, and an ~five-fold increase in the risk of major bleeding, and a 10-fold increase in the
risk of intracranial hemorrhage, compared with placebo, in patients with submassive and massive PE, and only
one-third of unstable PE patients (30%) received recommended thrombolytic therapy even when they are eligible.
These suboptimal results with anticoagulants have led to the use of other treatments such as catheter-directed
therapies (CDT). CDT includes catheter-directed thrombolysis (CDL) and catheter-based embolectomy. There are
some limitations to the use of CDL, including the risk of hemorrhage, doses are still being investigated, and the
evidence for the benefits of this technology is still lacking. Despite the compelling results of mechanical
thrombectomy (MT) landmark trials, MT in PE is rarely performed. Our extensive discovery interviews among
multiple KOLs have led us to identify the requirements of the new device to improve clinical outcomes and usability
acceptance and establish MT as gold-standard treatment for submassive and massive PE, which include: 1) safe
and smooth navigation into the PAs(<16F catheter); 2) rapid and continuous ingestion of emboli recanalizing large
and medium-size branches of the pulmonary tree (efficacy equivalent to >20F catheter); 3) directional
thrombectomy; 4) minimal blood loss; 5) negligible spillage of arrhythmogenic hemolysis byproducts. To address
these issues, we propose to develop an entirely new class of MT devices, named Vortex Catheter Technology (V-
CaTh), that augments suction catheters efficacy by a breakthrough mechanism we identified that generates a
powerful whirlpool by converting the high rotational energy transmitted by a high-torque shaft into a hydrodynamic
vortex. This mechanism enables the small catheter to remove large and stiff clots by progressive rotational
elongation and pulling of the clot into the catheter (“a device that is small but acts big”) while preventing
intravascular clot maceration and significantly reducing blood loss. We have previously completed extensive
foundational research and iterative prototyping of our device in the context of MT for stroke. In this Phase 1 SBIR,
we will expand the technological platform with pivotal engineering, development, and preclinical testing of a user-
specified V-CaTh system for thrombectomy in PE. In order to ensure the adequate performance of the V-CaTh
prototypes at key points along the development, we will carry out the following objectives: 1) user-specified de...

## Key facts

- **NIH application ID:** 10324705
- **Project number:** 1R43HL160292-01
- **Recipient organization:** ENDOVASCULAR ENGINEERING, INC.
- **Principal Investigator:** Michael Rosenthal
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $298,197
- **Award type:** 1
- **Project period:** 2021-09-20 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10324705

## Citation

> US National Institutes of Health, RePORTER application 10324705, Enhanced Suction Thrombectomy in Pulmonary Embolism Using Vortex Catheter Technology (1R43HL160292-01). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10324705. Licensed CC0.

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