What Angiosafe does

AngioSafe, Inc. is a privately held medical device company founded in 2015 and headquartered in San Jose, California. The company develops and commercializes endovascular devices for the treatment of peripheral artery disease (PAD), with a specific focus on chronic total occlusions (CTOs) and complex femoropopliteal lesions. AngioSafe claims to be the world's first philanthropic-funded medical device company, with investors reportedly committed to donating a percentage of returns to not-for-profit organizations; no institutional venture capital rounds have been disclosed.

The company's core product is the Santreva-ATK Endovascular Revascularization Catheter, powered by its proprietary Atheroplasty technology platform. Atheroplasty is a wire-free, external power-free system that combines three mechanisms — lateral intraplaque cutting, plaque compression, and channel formation — in a single device and single pass, eliminating the need for guidewires and capital equipment. The Santreva-ATK received CE Mark approval in July 2025 and FDA 510(k) clearance in September 2025, with U.S. commercial launch planned for October 2025 and first commercial real-world procedures performed in Italy in September 2025 through distribution partner Gada Italia. The RESTOR-1 pivotal trial supporting the U.S. clearance enrolled 74 patients across 14 U.S. sites, reporting a 90% overall success rate, 0% device-related major adverse events, and a mean lumen gain exceeding 55% in femoropopliteal arteries.

AngioSafe operates a hybrid go-to-market model combining a direct U.S. field sales force with international distribution partnerships. Revenue is generated through hardware sales of the Santreva-ATK catheter to hospitals and interventional radiology/cardiology departments; pricing is not publicly disclosed and is quoted through sales representatives or direct contact. The company's primary customer segments are hospitals, cardiac catheterization labs, and interventional specialists (interventional cardiologists, vascular surgeons, interventional radiologists) treating PAD patients, particularly those with CTOs — a lesion type encountered in up to 50% of symptomatic PAD patients globally.

Name

Angiosafe

Legal name

AngioSafe, Inc.

Website

https://angiosafe.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

AngioSafe is a San Jose-based medical device company that has developed the Santreva-ATK catheter, a wire-free endovascular system for treating chronic total occlusions in peripheral arteries. It sells primarily to hospitals and interventional cardiology/radiology departments across the U.S. and Europe.

Ownership category

akta.pro rank

Product category

Endovascular Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy) (HLAHAFAE)

akta.pro secondary industry

Vascular Medicine (Peripheral Arterial/Venous Disease) (HLAKABAG)

Keywords

• Endovascular catheters
• Peripheral artery disease
• Chronic total occlusion
• Atheroplasty devices
• Vascular revascularization

Headquarters

HQ city

San Jose

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Medical Device Sales: Sale of Santreva-ATK Endovascular Revascularization Catheter to hospitals and medical institutions for peripheral artery disease treatment. Device is ordered through sales representatives or by calling AngioSafe directly.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

AngioSafe develops and sells the Santreva-ATK Endovascular Revascularization Catheter, a single-use, wire-free, manually controlled catheter for treating chronic total occlusions (CTOs) in femoropopliteal peripheral arteries. Powered by its proprietary Atheroplasty platform, the device performs intraplaque traversal, lateral plaque compression, and channel formation in one pass without guidewires or external power. It is sold to hospitals and interventional cardiology, radiology, and vascular surgery departments for peripheral artery disease revascularization.

Product overview

AngioSafe is a medical device company that has developed a single unified product platform anchored by the Santreva-ATK Endovascular Revascularization Catheter, powered by its proprietary Atheroplasty technology. The Santreva-ATK is an all-in-one, wire-free, external power-free catheter system that combines three mechanisms—intraplaque crossing, plaque compression, and channel formation—in a single device for treating chronic total occlusions (CTOs) in femoropopliteal arteries. Unlike traditional CTO procedures requiring multiple devices, Santreva-ATK performs both crossing and vessel preparation in one pass.

Differentiator

Problem solved

Functional benefit

Brands

• Atheroplasty: Proprietary technology platform for endovascular revascularization combining lateral intraplaque cutting, compression, and channel formation
• Santreva-ATK

Products and services

• Santreva-ATK Endovascular Revascularization Catheter An all-in-one, large-profile, manually controlled, guidewire-free endovascular CTO crossing solution that simultaneously combines intraplaque traversal, axial plaque cutting, lateral plaque compression, and channel formation to revascularize severely or totally occluded femoropopliteal arteries. Designed for hospitals and interventional cardiologists, vascular surgeons, and interventional radiologists performing peripheral artery disease procedures.

Quantifiable outcome

• 90% overall success rate in RESTOR-1 pivotal trial
• +5 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Gada ItaliacoreChannel Partner/ Reseller/ Distributor · 1 September 2025Gada Italia is AngioSafe's distribution partner for Italy. This partnership enabled the first real-world patient procedures with Santreva-ATK at Policlinico Abano in Italy, performed by Dr. Marco Manzi. The distribution partner was chosen to facilitate market entry and commercialization in the European region following CE mark approval.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Penumbra: Penumbra's Indigo system for aspiration thrombectomy and peripheral mechanical thrombectomy devices compete head-to-head in the endovascular PAD/arterial occlusion space where AngioSafe's CTO-crossing catheter operates.
• AngioDynamics: AngioDynamics offers peripheral vascular products including the VenaCure EVLT system and Auryon atherectomy platform, directly competing in the PAD/atherectomy space AngioSafe addresses, particularly in femoropopliteal disease.
• Avinger: Avinger develops image-guided (OCT) atherectomy catheters (Pantheris, Tigereye) for treating PAD and CTOs. Directly comparable to AngioSafe as another small-cap peripheral CTO-crossing atherectomy developer with overlapping customer base of interventional cardiologists and vascular surgeons.
• Cardiovascular Systems Inc. Now part of Abbott, CSI pioneered orbital atherectomy (Diamondback) for PAD, including calcified femoropopliteal lesions and CTOs — the same clinical setting Santreva-ATK targets with its novel atheroplasty platform.

Broad incumbents

• Philips: Philips provides peripheral vascular imaging (IVUS with Volcano), atherectomy (Phoenix), and interventional devices — competing across the broader PAD/CTO treatment paradigm that AngioSafe's catheter addresses.
• Abbott: Abbott, now including Cardiovascular Systems Inc., offers Diamondback orbital atherectomy and a broad peripheral vascular portfolio, making it one of the largest direct competitors in the atherectomy/PAD segment where AngioSafe operates.
• Boston Scientific: Boston Scientific's peripheral intervention portfolio (Eluvia DES, Ranger DCB, Rotarex atherectomy thrombectomy, Vici venous stent) competes across the broader PAD/CTO treatment workflows that AngioSafe targets.
• Becton Dickinson: BD's peripheral intervention portfolio (Perclose vascular closure, Rotarex atherectomy-thrombectomy via acquired Bayer units, and other vascular access devices) provides adjacent competition for vascular occlusion/closure procedures AngioSafe targets.
• Medtronic: Medtronic's peripheral vascular portfolio includes IN.PACT Admiral drug-coated balloons, HawkOne directional atherectomy, and the ClosureRite closure device — competing broadly with AngioSafe across the femoropopliteal PAD/arterial occlusion workflow.

Emerging players

• Reflow Medical: Reflow Medical develops specialty peripheral devices (e.g., the Spur cathether system) focused on treating complex PAD and CTOs, positioning it as a direct small-competitor in AngioSafe's specific clinical niche.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/angiosafe

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Angiosafe