Affera, Inc.
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.
- Company typePrivate
- Founded2015
- HeadquartersWatertown, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Affera, Inc. firmographics
Firmographics- 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
Affera, Inc. industry classification
Industry- 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
Where Affera, Inc. is headquartered
LocationHeadquarters
- HQ city
- Watertown
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Affera, Inc. business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations, Others
Revenue model
- 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
Affera, Inc. product offering
Product offeringCore 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
Companies that use Affera, Inc.
Customer profileSegments2 records
Ideal customer profiles1 record
Affera, Inc. technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Affera, Inc. partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- MedtroniccoreMedtronic 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
Affera, Inc. competitors and assessment
Company assessmentDirect 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
Affera, Inc. social profiles
Digital presenceAffera, Inc. financial estimates
Financial estimateRevenue estimate
Valuation estimate
Affera, Inc. leadership team
Management profileNumber of profiles
Profiles4 records
Affera, Inc. funding detail
Funding detailFunding overview
Funding rounds2 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Affera, Inc. M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Affera, Inc.
What does Affera, Inc. do?
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.
Is Affera, Inc. a public or private company?
Affera, Inc. is a private company. It is classified as corporate owned and is currently acquired.
When was Affera, Inc. founded?
Affera, Inc. was founded in 2015. It employs 11 to 50 people.
Where is Affera, Inc. based?
Affera, Inc. is headquartered in Watertown, United States, in the North America region.
How does Affera, Inc. make money?
One revenue line is on record: cardiac Ablation Medical Devices.
Who are Affera, Inc.'s main competitors?
Direct peers on record are Stereotaxis, Acutus Medical, Kardium and AtriCure. Emerging players are Pulse Biosciences and Adagio Medical. Broad incumbents are Johnson & Johnson (Biosense Webster), Boston Scientific and Abbott. Medtronic (parent) is listed as an others.
Does Affera, Inc. have an API?
No public API is recorded for Affera, Inc..
What industry is Affera, Inc. in?
Affera, Inc.'s product category is Cardiac Electrophysiology Devices. Its primary akta.pro industry code is HLAHAFAD, Electrophysiology Mapping & Ablation Systems, with a secondary code of HLAKABAC, Electrophysiology (Heart Rhythm). Its NAICS code is 334510 and its SIC code is 3845.