What V-Wave does

V-Wave Ltd. is an Israel-based medical device company founded in 2009 (originally headquartered in Caesarea with a U.S. office in Agoura Hills, California) that developed the Ventura Interatrial Shunt, a novel hourglass-shaped, percutaneously implanted device designed to reduce elevated left atrial pressure by offloading blood volume from the left atrium to the right atrium in patients with heart failure with reduced ejection fraction (HFrEF). The shunt is encapsulated in expanded polytetrafluoroethylene (ePTFE) to limit tissue ingrowth, contains no battery or moving parts, and is delivered via a minimally invasive right-sided femoral catheterization procedure averaging approximately 80 minutes total (with roughly 14 minutes of fluoroscopy and no radiocontrast required). The device is MR Conditional at 1.5T and 3T, and is supported by at least three U.S. patents (10,251,740; 10,076,403; 11,850,138).

The company's clinical evidence base is anchored by the RELIEVE-HF pivotal randomized controlled trial, which enrolled 508 patients (plus 97 roll-in) across 94 hospitals in 11 countries and demonstrated a 48% reduction in heart failure hospitalizations and 45% reduction in combined cardiovascular events over 24 months in the HFrEF subgroup, with 100% implant success and 0% device-related major adverse events. V-Wave received FDA Breakthrough Device Designation (2019, both for heart failure and PAH) and CE Mark approval (March 2020), and is also pursuing a Pulmonary Arterial Hypertension (PAH) indication under an FDA IDE Early Feasibility Study.

V-Wave operated as a privately held, venture-backed pre-revenue company funded through a $28M Series B (2016), $70M Series C (2018), and up to $98M Series C extension (2020-2021), with a strategic syndicate that included Johnson & Johnson Innovation – JJDC and Edwards Lifesciences. On October 9, 2024, Johnson & Johnson completed the acquisition of V-Wave for $600 million upfront plus up to $1.1 billion in regulatory and commercial milestones (total deal value up to $1.7 billion), and V-Wave now operates as part of Johnson & Johnson MedTech, with future commercialization intended to leverage J&J's cardiovascular sales infrastructure targeting approximately 800,000 annual U.S. HFrEF patients. Notably, in December 2025 an FDA advisory panel rejected the Ventura Shunt over effectiveness concerns and the need for additional clinical data, creating material uncertainty for the U.S. regulatory and commercial pathway.

Name

V-Wave

Legal name

V-Wave Ltd.

Website

https://vwavemedical.com

Company type

Private

Founded year

2009

Operating status

Acquired

Headcount range

51–100 employees

Short description

V-Wave develops the Ventura Interatrial Shunt, a percutaneous implant that lowers left atrial pressure in NYHA Class III HFrEF patients. Acquired by Johnson & Johnson MedTech in October 2024 (up to $1.7B); remains an investigational device.

Ownership category

akta.pro rank

Product category

Cardiovascular Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industry

Interventional Cardiology (PCI/Structural Heart) (HLAKABAB)

Keywords

• Interatrial shunt device
• Heart failure therapy
• Cardiovascular medical devices
• Percutaneous implants
• Structural heart interventions

Headquarters

HQ city

Caesarea

HQ country

Israel

HQ region

Middle East

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales (Planned): V-Wave's Ventura Interatrial Shunt is an investigational device not yet commercially available. Upon regulatory approval, the product will be sold through Johnson & Johnson MedTech's cardiovascular sales infrastructure. Revenue will be generated through hospital/healthcare system purchases of the implantable device and associated procedural costs.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

V-Wave develops and intends to commercialize the Ventura Interatrial Shunt, a novel, hourglass-shaped, percutaneously implanted device with ePTFE biocompatible encapsulation designed to reduce elevated left atrial pressure by offloading volume from the left atrium to the right atrium in patients with NYHA Class III heart failure with reduced ejection fraction (HFrEF). The device is delivered via a minimally invasive right-sided femoral catheterization procedure and has FDA Breakthrough Device Designation and CE Mark approval.

Product overview

V-Wave is a medical device company with a single core product—the V-Wave Ventura Interatrial Shunt. This investigational device is a novel, hourglass-shaped shunt that creates a pathway between the left and right atrium to reduce elevated left atrial pressure in heart failure patients. The company was established in Israel in 2009 and was acquired by Johnson & Johnson in October 2024, becoming part of Johnson & Johnson MedTech. The Ventura Interatrial Shunt has received FDA Breakthrough Device Designation (2019) and CE Mark approval in the EU (2020), but remains an investigational device in the United States. The pivotal RELIEVE-HF trial demonstrated significant benefits for HFrEF patients, including 45% fewer cardiovascular events and 48% fewer heart failure hospitalizations over 24 months.

Differentiator

Problem solved

Functional benefit

Brands

• Ventura Interatrial Shunt: The V-Wave Ventura Interatrial Shunt is a novel, hourglass-shaped implantable device designed to reduce increases in left atrial pressure by offloading volume from the left atrium to the right atrium for treating heart failure.
• Magical Shunt

Products and services

• V-Wave Ventura Interatrial Shunt A novel, hourglass-shaped, percutaneously implanted interatrial shunt with ePTFE biocompatible encapsulation designed to reduce elevated left atrial pressure by offloading volume from the left atrium to the right atrium. It is intended for NYHA Class III heart failure patients with reduced ejection fraction (HFrEF, LVEF ≤40%) who remain symptomatic despite maximally tolerated guideline-directed medical therapy. The device is delivered via a minimally invasive right-sided femoral catheterization procedure.

Quantifiable outcome

• 48% reduction in heart failure hospitalizations over 24 months in HFrEF patients (LVEF ≤40%)
• +4 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core.

• RELIEVE-HF Clinical Trial Network (94 hospitals, 11 countries)coreStrategic or Co-development Partner · 6 April 2024V-Wave conducted the RELIEVE-HF pivotal trial at 94 hospitals across 11 countries including the U.S., EU, Israel, Australia, and New Zealand. Key principal investigators include Dr. Gregg Stone (Columbia University/Mount Sinai), Dr. Joann Lindenfeld (Vanderbilt), Dr. Stefan Anker (Charité Berlin), and Dr. Josep Rodés-Cabau (Laval University). First patients were implanted at Ohio State University Wexner Medical Center.
• EU Notified Body (CE Mark)coreStrategic or Co-development Partner · 5 March 2020The Ventura Interatrial Shunt System received CE Mark approval in March 2020, certifying conformance to European Medical Device Directive standards and enabling marketing in the European Union.
• FDA (Breakthrough Devices Program)coreStrategic or Co-development Partner · 12 September 2019The FDA granted V-Wave's interatrial shunt Breakthrough Device Designation in August 2019 for heart failure, and a second designation in September 2019 for pulmonary arterial hypertension. The Breakthrough Devices Program facilitates interactive communication with the FDA and prioritized review of submissions and marketing applications.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Corvia Medical: Corvia Medical develops the InterAtrial Shunt Device (IASD), the most direct competitor to V-Wave's Ventura. Both target NYHA Class III HFrEF patients via percutaneous interatrial shunting to reduce left atrial pressure, making Corvia the closest head-to-head competitor in clinical and commercial positioning.

Broad incumbents

• Edwards Lifesciences: Edwards Lifesciences is a global leader in structural heart therapies (TAVR/surgical valves) and was an early V-Wave investor via its Series B. Its structural heart sales channel and heart failure focus make it a broad incumbent competitor and a potential strategic acquirer in the heart failure device space.
• Abbott: Abbott's cardiovascular portfolio (CardioMEMS HF System, MitraClip, structural heart) competes in the same heart failure and structural heart cath lab channels where Ventura will be commercialized. CardioMEMS in particular addresses a similar NYHA Class III HF population via pulmonary pressure monitoring.
• Medtronic: Medtronic is a major cardiovascular medical device incumbent with heart failure, structural heart, and interventional cardiology franchises. Its scale and cath lab relationships make it a broad incumbent competitor for hospital purchasing decisions in the HFrEF device category.
• Boston Scientific: Boston Scientific's interventional cardiology and structural heart portfolio (Watchman, ACURATE neo) competes for the same hospital cath lab resources and physician mindshare as V-Wave's Ventura Shunt, particularly in heart failure patients with comorbidities.

Emerging players

• Ancora Heart: Ancora Heart is developing the AccuCinch System, a percutaneous ventricular repair device for HFrEF. It targets a similar NYHA Class III HFrEF patient population via a different mechanism (ventricular reshaping rather than atrial shunting), making it a partial-overlap emerging competitor.
• BioVentrix: BioVentrix develops the Revivent TC system for less invasive ventricular restoration in ischemic heart failure patients. Like V-Wave, it targets advanced HFrEF patients and is an emerging structural heart player with overlapping cath lab/heart failure treatment positioning.
• Cardiac Dimensions: Cardiac Dimensions markets the Carillon Mitral Contour System for functional mitral regurgitation in heart failure patients. It addresses an overlapping HF patient population and uses a similar percutaneous catheter-based delivery approach in the structural heart cath lab setting.
• Axon Therapies: Axon Therapies is developing splanchnic nerve ablation (SNA) for heart failure, targeting a similar HFrEF/NYHA Class III population via a catheter-based procedure. It represents an emerging alternative interventional approach that could compete with Ventura for the same patient and physician base.

Others

• Shockwave Medical: Shockwave Medical (acquired by J&J in 2024 for $13B alongside V-Wave) is a sibling J&J MedTech cardiovascular asset. While focused on intravascular lithotripsy rather than heart failure, it shares the same J&J cardiovascular sales channel and serves as a useful comp for J&J's cardiovascular go-to-market playbook that V-Wave will leverage.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/v-wave
• Xx.com/vwavemedical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds5 records

Investors13 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 V-Wave