# PERCUTANEOUS TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WITH IMPLANTATION OF MULTIPLE, BALLOON-EXPANDABLE, DRUG-ELUTING BIORESORBABLE SCAFFOLDS (the Efemoral Vascular Scaffold System)

> **NIH NIH R44** · EFEMORAL MEDICAL, INC. · 2023 · $1,192,988

## Abstract

Cardiovascular disease is a tremendous burden on human health and longevity; by the year 2030, over 400 
million people will have the disease including an annual mortality of more than 23 million. Vascular disease 
affecting the lower extremity arteries, known as “peripheral arterial occlusive disease” (PAOD), is an epidemic 
affecting approximately 10% of the population over the age of 50 and 20% of the population over the age of 70. 
Its prevalence is increasing at an alarming rate, by more than 20% over the last decade. Symptomatic PAOD 
causes loss of mobility, poor physical health, decreased quality of life, premature decline and early mortality. 
The physical burden of PAOD is greater than having congestive heart failure and the long-term prognosis is 
worse than having coronary artery disease. An estimated 11% of patients afflicted with PAOD have the most 
severe form of the disease: critical limb ischemia (CLI). CLI occurs when the occlusive lesions of PAOD have 
become so numerous and severe that the baseline perfusion of the extremity is inadequate to sustain its 
viability. It carries a dismal prognosis; only about half of affected patients will be alive with viable limbs only six 
months after the diagnosis is made.
The standard-of-care for patients with symptomatic PAOD is percutaneous peripheral intervention (PPI) 
including the techniques of balloon angioplasty, drug-coated balloon angioplasty, percutaneous atherectomy, 
and bare and drug-eluting self-expanding stenting. Unfortunately, the effectiveness and durability of available 
devices is limited as up to 50% of conventional endovascular procedures will be complicated by arterial 
restenosis and recurrence within the first year. This research proposal describes the development of novel, 
serial, balloon-expandable, resorbable, drug-eluting scaffold designed to provide more immediately effective 
and durable endovascular treatment of symptomatic femoropopliteal occlusive disease.
Unlike most peripheral intravascular devices that are simply adaptations and “scale-ups” of coronary 
devices, the Efemoral Vascular Scaffold System (EVSS) is specifically designed for the unique environment of 
the peripheral vasculature. Its design exploits known principles of vascular biology including that, (1) a rigid 
device that is deployed via balloon expansion represents the optimal design of an intravascular stent given its 
transient effect on the arterial wall and relative ease of precise implantation, (2) a long, rigid device cannot be 
safely implanted in an artery that bends and twists with skeletal motion, (3) long arteries that bend and twist 
could be effectively treated with multiple, short stents that allow the intervening, non-stented arterial segments 
to move unencumbered, (4) the length, number and spacing of the stent segments could be determined by the 
known bending characteristics of the target arteries, and (5) arteries need only be scaffolded transiently; late 
dissolution ...

## Key facts

- **NIH application ID:** 10706525
- **Project number:** 5R44HL165972-02
- **Recipient organization:** EFEMORAL MEDICAL, INC.
- **Principal Investigator:** Lewis Schwartz
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,192,988
- **Award type:** 5
- **Project period:** 2022-09-19 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10706525

## Citation

> US National Institutes of Health, RePORTER application 10706525, PERCUTANEOUS TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WITH IMPLANTATION OF MULTIPLE, BALLOON-EXPANDABLE, DRUG-ELUTING BIORESORBABLE SCAFFOLDS (the Efemoral Vascular Scaffold System) (5R44HL165972-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10706525. Licensed CC0.

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