Affera, Inc.

What Affera, Inc. does

Affera, Inc. is a medical technology company developing an integrated cardiac mapping and ablation platform for the treatment of atrial fibrillation and other cardiac arrhythmias. The company's core technology combines high-density mapping with both pulsed field ablation (PFA) and radiofrequency (RF) energy delivery in a unified workflow, built around a proprietary lattice-tip focal catheter design (the Sphere-9) that allows the physician to toggle between RF and PFA modalities during a single procedure. The platform also includes the Sphere-360 single-shot PFA catheter for paroxysmal atrial fibrillation pulmonary vein isolation. Affera serves hospitals and electrophysiology (EP) labs performing catheter ablation procedures, with primary clinical use cases in persistent AFib, CTI-dependent atrial flutter, and pulmonary vein isolation.

The company's technology foundation is rooted in founder Doron Harlev's earlier work at Rhythmia Medical (acquired by Boston Scientific in 2012), which became Boston Scientific's cardiac mapping and navigation franchise; Harlev holds over 160 issued and pending patents in cardiac mapping and ablation. Affera demonstrated first-in-human focal PFA in late 2019 and completed enrollment of the pivotal SPHERE Per-AF IDE trial in December 2022, supporting a CE Mark in Europe (March 2023) and FDA approval of the Affera Mapping and Ablation System with the Sphere-9 catheter in October 2024.

Affera was acquired by Medtronic in August 2022 for approximately $925 million to $1 billion and now operates as a wholly-owned Medtronic subsidiary, maintaining its brand identity while leveraging Medtronic's global electrophysiology sales force and hospital relationships. The business model is hardware sales of capital equipment and disposable catheters to hospitals and EP labs. The company is headquartered in Newton, Massachusetts, with 11–50 employees as of the latest firmographic data. Medtronic has guided to limited revenue contribution in fiscal 2025 with a fuller ramp in fiscal 2026.

Name

Affera, Inc.

Legal name

Affera, Inc.

Website

https://affera.com

Company type

Private

Founded year

2015

Operating status

Acquired

Headcount range

11–50 employees

Short description

Affera, a Medtronic subsidiary, develops an integrated cardiac mapping and ablation platform combining high-density mapping with pulsed field and radiofrequency ablation via its proprietary lattice-tip catheter, serving hospitals and electrophysiology labs treating atrial fibrillation patients.

Ownership category

akta.pro rank

Product category

Cardiac Electrophysiology Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Electrophysiology Mapping & Ablation Systems (HLAHAFAD)

akta.pro secondary industries

Electrophysiology (Heart Rhythm) (HLAKABAC), Cardiac Rhythm Management (Pacemakers, ICDs, CRT) (HLAHAFAC)

Keywords

• Cardiac ablation systems
• Pulsed field ablation
• Electrophysiology devices
• Cardiac mapping technology
• Atrial fibrillation treatment

Headquarters

HQ city

Watertown

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Cardiac Ablation Medical Devices: Medtronic generates revenue through the sale of the Affera mapping and ablation system, Sphere-9 catheter, and Sphere-360 PFA catheter to hospitals and electrophysiology labs. Medtronic expects limited revenue contribution in fiscal 2025 with fuller ramp expected in fiscal 2026.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Affera develops an integrated cardiac mapping and ablation platform that combines high-density mapping with both pulsed field ablation (PFA) and radiofrequency (RF) capabilities. Its proprietary lattice-tip focal catheter enables physicians to toggle between RF and PFA energy within a single procedure for treating persistent atrial fibrillation, paroxysmal AF, CTI-dependent atrial flutter, and pulmonary vein isolation. The product family includes the Affera Mapping and Ablation System, the Sphere-9 catheter, the Sphere-360 single-shot PFA catheter, and the SpherePVI circumferential PVI device.

Product overview

Affera, a Medtronic company, offers a comprehensive integrated platform for cardiac arrhythmia treatment centered on the Affera Mapping and Ablation System. The system incorporates the Sphere-9 catheter for high-density mapping and ablation, and works with the Sphere-360 PFA catheter for single-shot pulmonary vein isolation. The Lattice-Tip Focal Ablation Catheter provides additional flexibility by toggling between radiofrequency and pulsed field energy modalities. This multi-product approach enables physicians to perform persistent atrial fibrillation ablation, CTI-dependent atrial flutter treatment, and pulmonary vein isolation procedures with a unified workflow.

Differentiator

Problem solved

Functional benefit

Brands

• Affera Mapping and Ablation System: An integrated mapping and ablation system combining high-density mapping with both pulsed field ablation and radiofrequency ablation capabilities.
• Sphere-9 Catheter
• Sphere-360 PFA Catheter

Products and services

• Affera Mapping and Ablation System An integrated cardiac mapping and ablation system that combines high-density mapping technology with a catheter capable of both radiofrequency (RF) and pulsed field ablation (PFA) for treating persistent atrial fibrillation and CTI-dependent atrial flutter. Sold to hospitals and electrophysiology labs.
• Sphere-9 Catheter High-density mapping and focal ablation catheter used with the Affera Mapping and Ablation System; capable of both pulsed field ablation and radiofrequency ablation, offering physicians workflow efficiency and treatment flexibility. Used in hospitals and EP labs.
• Sphere-360 PFA Catheter Pulsed field ablation catheter designed for single-shot pulmonary vein isolation to treat paroxysmal atrial fibrillation, used by electrophysiologists in hospital EP labs.
• Lattice-Tip Focal Ablation Catheter A focal ablation catheter that toggles between radiofrequency and pulsed field energy using proprietary lattice-tip technology for precise energy delivery and durable lesion formation; used by electrophysiologists for atrial fibrillation ablation.

Quantifiable outcome

• Positive results from pivotal SPHERE Per-AF study supporting FDA approval

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• MedtroniccoreStrategic or Co-development Partner · 30 August 2022Medtronic acquired Affera in August 2022 for approximately $1 billion, bringing Affera's mapping and ablation system under Medtronic's cardiac rhythm management portfolio. The acquisition combines Affera's innovative technology with Medtronic's global distribution network and resources for commercialization. Affera operates as a Medtronic company while maintaining its brand identity.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Stereotaxis: Stereotaxis develops robotic magnetic navigation systems for cardiac ablation procedures. While not a direct catheter competitor, it competes for EP lab capital budgets and procedural workflow integration alongside Affera's mapping and ablation system.
• Acutus Medical: Acutus Medical developed the AcQMap high-resolution imaging and mapping system for cardiac arrhythmias. Competes with Affera in the high-density mapping segment of EP labs and pursues similar catheter ablation workflows.
• Kardium: Kardium is developing the Globe PF System, a single-shot PFA catheter for atrial fibrillation. Directly competes with Affera's Sphere-360 catheter in the emerging single-shot pulmonary vein isolation segment of the PFA market.
• AtriCure: AtriCure develops ablation devices primarily for atrial fibrillation and left atrial appendage management, including the cryoICE and Isolator Synergy clamps. Targets the same EP and cardiac surgery customer base as Affera with complementary ablation technologies.

Emerging players

• Pulse Biosciences: Pulse Biosciences is developing nanosecond pulsed field ablation (nsPFA) technology for cardiac and tissue applications. Represents an emerging PFA modality that could compete with Affera's standard PFA approach as the ablation energy landscape evolves.
• Adagio Medical: Adagio Medical is developing the vCLAS catheter for ultra-low-temperature cryoablation to treat atrial fibrillation and ventricular tachycardia. Competes with Affera's PFA technology in the next-generation persistent AFib ablation segment.

Broad incumbents

• Johnson & Johnson (Biosense Webster): Biosense Webster is the market leader in cardiac electrophysiology with the CARTO 3 mapping system and Thermocool/SmartTouch SF ablation catheters, plus its own PFA program (Varipulse). It directly competes with Affera's lattice-tip PFA/RF system for EP lab share.
• Boston Scientific: Boston Scientific acquired Rhythmia Medical (co-founded by Affera's CEO Doron Harlev) and now offers the Rhythmia mapping system plus the Farapulse PFA catheter. It is the most direct large-cap competitor to Affera's integrated mapping+ablation approach in the EP market.
• Abbott: Abbott's electrophysiology business includes the EnSite X mapping system and TactiFlex ablation catheter, plus its Volt PFA system in development. Competes with Affera for hospital EP lab capital equipment and disposable ablation catheter contracts.

Others

• Medtronic (parent): Medtronic acquired Affera in 2022 and now sells both the Pulseselect PFA catheter and the Affera system under its cardiac rhythm portfolio. As Affera's parent and largest distribution channel, Medtronic sets the competitive landscape for the Affera platform.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/MDT_Cardiac
• LinkedInlinkedin.com/showcase/medtronic-cardiac-and-vascular-

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds2 records

Investors3 records

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 Affera, Inc.