Corvia Medical

What Corvia Medical does

Corvia Medical is a privately held medical device company founded in 2009 and headquartered in Tewksbury, Massachusetts. The company develops the Corvia Atrial Shunt System (IASD), a transcatheter, self-expanding interatrial implant that creates an 8mm passage between the left and right atria to dynamically decompress elevated left atrial pressure (LAP), the primary hemodynamic contributor to symptoms in heart failure with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF). The device features a reinforced barrel for long-term patency, a flat left atrial profile to promote endothelialization, adjustable right atrial legs to accommodate variable septal anatomy, and MR Conditional labeling at 1.5T and 3T. More than 675 implants have been performed across 18 countries and 100+ hospitals, with 250+ patients past five years and some beyond 10 years, supported by 30+ peer-reviewed publications and 2,300+ patient-years of follow-up.

The company's revenue model is hardware sales of a Class III implantable cardiac device on a per-procedure basis to hospitals and cardiac centers. In the European Union, the device is commercially available under CE Mark certification achieved under EU MDR 2017/745 in December 2024, with NUB-1 reimbursement status granted in Germany for calendar year 2026. In the United States the device remains investigational and is provided only through clinical trial sites, with the ongoing RESPONDER-HF confirmatory trial (266 patients enrolled across 65+ institutions on three continents) designed to support FDA approval. Customer concentration is across major academic medical centers and integrated delivery networks, with KOL engagement and direct enterprise sales as the primary go-to-market motion. The company has raised over $109M across multiple equity rounds, with a $35M investment from Edwards Lifesciences in 2019 that included an exclusive acquisition option.

Name

Corvia Medical

Legal name

Corvia Medical, Inc.

Website

https://corviamedical.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Corvia Medical develops the Corvia Atrial Shunt System (IASD), a transcatheter implant that dynamically reduces elevated left atrial pressure in heart failure patients with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF) who remain symptomatic despite guideline-directed medical therapy.

Ownership category

akta.pro rank

Product category

Structural Heart Implants

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

akta.pro secondary industry

Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)

Keywords

• Transcatheter heart devices
• Atrial shunt implant
• Heart failure treatment
• Interventional cardiology devices
• Structural heart implants

Headquarters

HQ city

Andover

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, Marketing or Sales, Supply Chain

Revenue model

1. Medical Device Sales (Atrial Shunt Implant): Corvia Medical generates revenue through the sale of its Corvia Atrial Shunt System, a transcatheter cardiac implant. The device is commercially available in the European Union (CE marked) and is sold to hospitals and cardiac centers. In the US, the device remains investigational pending FDA approval. Revenue is generated on a per-procedure basis as implants are performed.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Corvia Medical develops and manufactures the Corvia Atrial Shunt System (IASD), a transcatheter cardiac implant that creates a passage between the left and right atria to reduce elevated left atrial pressure in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF). The device is commercially available in the European Union under CE Mark and is provided through clinical trials in the United States pending FDA approval.

Product overview

Corvia Medical's portfolio centers on a single core product: the Corvia Atrial Shunt System (IASD®), a novel transcatheter cardiac implant designed to treat heart failure with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF) by reducing elevated left atrial pressure. The device is supported by an extensive clinical program anchored by the REDUCE LAP-HF II pivotal trial (the world's first phase III atrial shunt trial) and the ongoing RESPONDER-HF confirmatory trial intended to support FDA approval. Additional offerings include multi-language patient information guides for implant recipients. The company is pursuing both FDA approval in the US (where the device holds Breakthrough Device designation and is investigational) and commercial expansion in Europe under EU MDR CE certification.

Differentiator

Problem solved

Functional benefit

Brands

• Corvia Atrial Shunt System (IASD): The Corvia Atrial Shunt System (IASD) is a novel, minimally invasive cardiac implant for patients suffering from Heart Failure with Preserved Ejection Fraction (HFpEF) or Mildly Reduced Ejection Fraction (HFmrEF).

Products and services

• Corvia Atrial Shunt System (IASD) A novel, minimally invasive transcatheter cardiac implant that creates a passage between the left and right atria to reduce elevated left atrial pressure (LAP), the primary contributor to heart failure symptoms in patients with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF). The 8mm shunt enables dynamic decompression of the left atrium, reducing HF hospitalizations and improving quality of life. Sold to hospitals and cardiac centers in EU; provided through clinical trials in US.

Quantifiable outcome

• 41% relative reduction in heart failure-related hospitalizations in responder patients at 5 years (18% vs 30% in control, p=0.021)
• +10 more outcomes

Named customers7 records

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators8 records

Expansion highlights5 records

Direct peers

• V-Wave: V-Wave developed the Ventura interatrial shunt, the closest direct competitor to Corvia's IASD for HFpEF/HFmrEF. V-Wave was acquired by Edwards Lifesciences in 2024, making Corvia's exclusive partner also the owner of its primary rival, intensifying competitive dynamics.

Broad incumbents

• Edwards Lifesciences: Global structural heart leader and Corvia's strategic investor since 2019 with an exclusive acquisition option. Edwards' PASCAL and TAVR franchises make it a broad incumbent in the structural heart space overlapping Corvia's HFpEF interventional cardiology channel.
• Abbott: Abbott's structural heart and heart failure portfolio (CardioMEMS HF System, mechanical circulatory support, Amplatzer occluders) competes for the same interventional cardiology and HF cardiologist mindshare that Corvia targets through RESPONDER-HF.
• Medtronic: Medtronic's cardiovascular portfolio spans structural heart, cardiac surgery, and HF. While it does not currently market an atrial shunt, it competes broadly for hospital system interventional cardiology budgets and could enter the atrial shunt category organically or via M&A.
• Boston Scientific: Boston Scientific's Watchman, ACURATE, and emerging heart failure programs place it as a broad incumbent in structural heart and interventional cardiology. It is a credible strategic acquirer in the interatrial shunt category should Corvia's Edwards option lapse or be waived.

Emerging players

• Occlutech: Occlutech has developed atrial flow regulator (AFR) devices targeting HFpEF and other structural heart indications. It represents an emerging direct competitor in the interatrial shunt category with EU presence and investigational programs in the US.
• Ancora Heart: Ancora Heart is developing the AccuCinch ventricular reshaping system for HFpEF/HFrEF. While targeting a different mechanism (ventricular rather than atrial), it competes for the same HFpEF physician and patient population targeted by Corvia.
• BioVentrix: BioVentrix develops the Revivent TC system for ventricular reshaping in heart failure. Corvia CEO George Fazio serves on BioVentrix's board, and the two companies share interventional heart failure physician relationships, making BioVentrix a thematic emerging peer.
• Shifamed: Shifamed is a medical device incubator with multiple portfolio companies in interventional cardiology and heart failure. Several Shifamed portfolio companies intersect with Corvia's structural heart and HFpEF therapeutic space.
• Vectorious Medical Technologies: Vectorious is developing an implantable left atrial pressure sensor for heart failure monitoring. While a monitoring rather than therapeutic device, it targets the same HFpEF/HFmrEF patient population and shares clinical development risk in the broader HFpEF ecosystem.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/corviamedical
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• LinkedInlinkedin.com/company/corvia-medical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds7 records

Investors4 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 Corvia Medical