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Keystone Heart

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Keystone Heart
Company typeenum
Private
Founded yearint
2004
Descriptiontext

Keystone Heart is a privately held Israeli medical device company founded in 2004 and headquartered in Herzliya, Israel. It develops cerebral embolic protection devices intended to capture and remove debris dislodged during cardiovascular procedures — most notably transcatheter aortic valve replacement (TAVR) and other structural heart interventions — to reduce the risk of periprocedural stroke. The company's flagship product line addresses a specific clinical gap in structural heart procedures, sold into hospital catheterization laboratories and hybrid operating rooms performing these interventions.

The company has pursued a focused, niche-device commercial strategy supported by a single disclosed institutional funding round — a $14 million Series 2 in May 2014 led by OrbiMed with participation from Caesarea Medical Electronics. In June 2020, Keystone Heart acquired 510 Kardiac Devices for an undisclosed sum, signaling an intent to broaden its cardiac device portfolio beyond cerebral protection. The company operates with a small team (11–50 employees) and no disclosed manufacturing, distribution, or pricing model.

Public visibility into Keystone Heart is currently limited: the corporate website resolves to a default cPanel page, indicating either a hosting/server issue or that the domain has been deprioritized. No customer logos, revenue figures, headcount trend, recent product launches, regulatory milestones, or strategic partnerships beyond the 2014 funding and 2020 acquisition are disclosed in the available data. Leadership consists of Shuki Porath (President & CEO), Yuval Shezifi (CTO), and Pauliina Margolis (CMO & VP).

Short descriptiontext

Keystone Heart is an Israeli medical device company developing cerebral embolic protection devices used during TAVR and other cardiovascular procedures to reduce stroke risk, selling primarily to hospital structural heart programs.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersHerzliya, Israel
HQ citystring
Herzliya
HQ countrystring
Israel
HQ regionstring
Middle East
Markets served

Serves global market

Keyword5 values
cerebral embolic protection, cardiovascular medical devices, TAVR procedure devices, stroke prevention devices, embolic protection systems
Industry3 codes
1Thrombectomy, Embolic Protection & Stroke Intervention Devices
CodeHLAHAFAJPrimaryYes
2Structural Heart Valves (TAVR/SAVR) & Valve Repair
CodeHLAHAFABPrimaryNo
3Interventional Cardiology (PCI/Structural Heart)
CodeHLAKABABPrimaryNo
NAICS code2 codes
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
  • Navigational, Measuring, Electromedical, and Control Instruments Manufacturing33451
SIC code2 codes
  • Electromedical & Electrotherapeutic Apparatus3845
  • Surgical & Medical Instruments & Apparatus3841
Product category
Cerebral Embolic Protection Devices
Social media profiles1 record
Cost components5 values
Technology or R&D, Operations, Personnel, Marketing or Sales, Others
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Keystone Heart develops and manufactures cerebral embolic protection medical devices used during cardiovascular procedures, including TAVR (Transcatheter Aortic Valve Replacement), intended to reduce the risk of peri-procedural stroke by capturing embolic debris. The company operates in the cerebral protection segment of the cardiovascular medical device market and expanded its portfolio through the 2020 acquisition of 510 Kardiac Devices.

Differentiator
Functional benefit
Problem solved
Product and service2 records
1Cerebral embolic protection devices
CategoryCerebral embolic protection
Description

Devices used during cardiovascular procedures, including TAVR (Transcatheter Aortic Valve Replacement), designed to capture embolic debris and reduce the risk of peri-procedural stroke. Sold to hospitals and cardiac care providers.

2Cardiac devices (via 510 Kardiac Devices)
CategoryCardiac medical devices
Description

Cardiac device products obtained through the acquisition of 510 Kardiac Devices on 2020-06-16, expanding Keystone Heart's cardiovascular portfolio beyond cerebral embolic protection.

Recent move2 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight3 records

Each record includes

Type, Description

Peers8 records
TypeBroad incumbent
Description

Boston Scientific markets the Sentinel Cerebral Protection System, the leading cerebral embolic protection device for TAVR procedures — the most direct competitive product to Keystone Heart's offering. As a major incumbent cardiovascular device company, Boston Scientific competes head-to-head with Keystone Heart for hospital contracts and physician adoption in the same clinical specialty.

TypeEmerging player
Description

Protembis is developing the ProtEmbo cerebral protection system designed for use during TAVR and other left-sided structural heart procedures. It is a direct emerging competitor to Keystone Heart's cerebral embolic protection device, targeting the same clinical niche with a similar deflector-style filter concept.

TypeEmerging player
Description

Emboline has developed the Emboliner catheter, a total embolic protection device designed for transcatheter aortic valve replacement and other cardiovascular procedures. It overlaps with Keystone Heart on embolic protection technology, target indication (TAVR), and end-user base (interventional cardiologists and heart teams).

TypeBroad incumbent
Description

Edwards Lifesciences is the dominant TAVR valve manufacturer (Sapien platform) and a key customer-channel partner and indirect competitor to embolic protection players. While Edwards does not primarily sell cerebral protection devices, its installed base makes it a critical reference point for adoption and procedural volumes directly impacting Keystone Heart's market opportunity.

TypeBroad incumbent
Description

Medtronic is a leading structural heart and TAVR player (Evolut platform) with broad cardiovascular device portfolio. As a major TAVR valve manufacturer and an integrated device company potentially evaluating or expanding into cerebral embolic protection, Medtronic is a comparable incumbent in the broader structural heart/cath lab ecosystem.

TypeBroad incumbent
Description

Abbott operates structural heart, vascular, and cardiovascular device franchises (including Portico TAVR). Comparable to Keystone Heart as a broad cardiovascular incumbent serving interventional cardiology and structural heart teams with potential strategic interest in cerebral embolic protection.

TypeRegional player
Description

Venus Medtech is a leading Chinese structural heart company focused on TAVR and related devices across Asia-Pacific. Comparable to Keystone Heart through shared structural heart focus, TAVR exposure, and overlapping interest in embolic protection for transcatheter procedures across major geographic markets.

TypeEmerging player
Description

InspireMD develops embolic prevention and stroke prevention systems including the CGuard carotid stent platform. Comparable as a smaller emerging player in the embolic protection / stroke prevention medical device space with similar regulatory and clinical-trial-driven go-to-market profile.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat3 records

Each record includes

Type, Details

Key risks4 records

Each record includes

Headline, Details, Source

Key highlights5 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles3 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds1 record

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors2 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

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

M&A1 record

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

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

Keystone Heart

Cerebral Embolic Protection Deviceskeystoneheart.com

Keystone Heart is an Israeli medical device company developing cerebral embolic protection devices used during TAVR and other cardiovascular procedures to reduce stroke risk, selling primarily to hospital structural heart programs.

What Keystone Heart does

Keystone Heart is a privately held Israeli medical device company founded in 2004 and headquartered in Herzliya, Israel. It develops cerebral embolic protection devices intended to capture and remove debris dislodged during cardiovascular procedures — most notably transcatheter aortic valve replacement (TAVR) and other structural heart interventions — to reduce the risk of periprocedural stroke. The company's flagship product line addresses a specific clinical gap in structural heart procedures, sold into hospital catheterization laboratories and hybrid operating rooms performing these interventions.

The company has pursued a focused, niche-device commercial strategy supported by a single disclosed institutional funding round — a $14 million Series 2 in May 2014 led by OrbiMed with participation from Caesarea Medical Electronics. In June 2020, Keystone Heart acquired 510 Kardiac Devices for an undisclosed sum, signaling an intent to broaden its cardiac device portfolio beyond cerebral protection. The company operates with a small team (11–50 employees) and no disclosed manufacturing, distribution, or pricing model.

Public visibility into Keystone Heart is currently limited: the corporate website resolves to a default cPanel page, indicating either a hosting/server issue or that the domain has been deprioritized. No customer logos, revenue figures, headcount trend, recent product launches, regulatory milestones, or strategic partnerships beyond the 2014 funding and 2020 acquisition are disclosed in the available data. Leadership consists of Shuki Porath (President & CEO), Yuval Shezifi (CTO), and Pauliina Margolis (CMO & VP).

Keystone Heart firmographics

Firmographics
Name
Keystone Heart
Website
https://keystoneheart.com
Company type
Private
Founded year
2004
Operating status
Operating
Headcount range
11–50 employees
Short description
Keystone Heart is an Israeli medical device company developing cerebral embolic protection devices used during TAVR and other cardiovascular procedures to reduce stroke risk, selling primarily to hospital structural heart programs.
Ownership category
akta.pro rank

Keystone Heart industry classification

Industry
Product category
Cerebral Embolic Protection Devices
NAICS
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)
SIC
Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)
akta.pro primary industry
Thrombectomy, Embolic Protection & Stroke Intervention Devices (HLAHAFAJ)
akta.pro secondary industries
Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB), Interventional Cardiology (PCI/Structural Heart) (HLAKABAB)

Keywords

  • Cerebral embolic protection
  • Cardiovascular medical devices
  • TAVR procedure devices
  • Stroke prevention devices
  • Embolic protection systems

Where Keystone Heart is headquartered

Location

Headquarters

HQ city
Herzliya
HQ country
Israel
HQ region
Middle East

Markets served

Keystone Heart business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Operations, Personnel, Marketing or Sales, Others

Keystone Heart product offering

Product offering

Core offering

Keystone Heart develops and manufactures cerebral embolic protection medical devices used during cardiovascular procedures, including TAVR (Transcatheter Aortic Valve Replacement), intended to reduce the risk of peri-procedural stroke by capturing embolic debris. The company operates in the cerebral protection segment of the cardiovascular medical device market and expanded its portfolio through the 2020 acquisition of 510 Kardiac Devices.

Differentiator

Problem solved

Functional benefit

Products and services

  • Cerebral embolic protection devices Devices used during cardiovascular procedures, including TAVR (Transcatheter Aortic Valve Replacement), designed to capture embolic debris and reduce the risk of peri-procedural stroke. Sold to hospitals and cardiac care providers.
  • Cardiac devices (via 510 Kardiac Devices) Cardiac device products obtained through the acquisition of 510 Kardiac Devices on 2020-06-16, expanding Keystone Heart's cardiovascular portfolio beyond cerebral embolic protection.

Companies that use Keystone Heart

Customer profile

Ideal customer profiles1 record

Keystone Heart technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Keystone Heart partnerships and signals

Strategic signal

Recent moves2 records

Expansion highlights3 records

Keystone Heart competitors and assessment

Company assessment

Broad incumbents

  • Boston Scientific: Boston Scientific markets the Sentinel Cerebral Protection System, the leading cerebral embolic protection device for TAVR procedures — the most direct competitive product to Keystone Heart's offering. As a major incumbent cardiovascular device company, Boston Scientific competes head-to-head with Keystone Heart for hospital contracts and physician adoption in the same clinical specialty.
  • Edwards Lifesciences: Edwards Lifesciences is the dominant TAVR valve manufacturer (Sapien platform) and a key customer-channel partner and indirect competitor to embolic protection players. While Edwards does not primarily sell cerebral protection devices, its installed base makes it a critical reference point for adoption and procedural volumes directly impacting Keystone Heart's market opportunity.
  • Medtronic: Medtronic is a leading structural heart and TAVR player (Evolut platform) with broad cardiovascular device portfolio. As a major TAVR valve manufacturer and an integrated device company potentially evaluating or expanding into cerebral embolic protection, Medtronic is a comparable incumbent in the broader structural heart/cath lab ecosystem.
  • Abbott Vascular: Abbott operates structural heart, vascular, and cardiovascular device franchises (including Portico TAVR). Comparable to Keystone Heart as a broad cardiovascular incumbent serving interventional cardiology and structural heart teams with potential strategic interest in cerebral embolic protection.

Emerging players

  • Protembis: Protembis is developing the ProtEmbo cerebral protection system designed for use during TAVR and other left-sided structural heart procedures. It is a direct emerging competitor to Keystone Heart's cerebral embolic protection device, targeting the same clinical niche with a similar deflector-style filter concept.
  • Emboline: Emboline has developed the Emboliner catheter, a total embolic protection device designed for transcatheter aortic valve replacement and other cardiovascular procedures. It overlaps with Keystone Heart on embolic protection technology, target indication (TAVR), and end-user base (interventional cardiologists and heart teams).
  • InspireMD: InspireMD develops embolic prevention and stroke prevention systems including the CGuard carotid stent platform. Comparable as a smaller emerging player in the embolic protection / stroke prevention medical device space with similar regulatory and clinical-trial-driven go-to-market profile.

Regional players

  • Venus Medtech: Venus Medtech is a leading Chinese structural heart company focused on TAVR and related devices across Asia-Pacific. Comparable to Keystone Heart through shared structural heart focus, TAVR exposure, and overlapping interest in embolic protection for transcatheter procedures across major geographic markets.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks4 records

Key highlights5 records

Customer concentration

Keystone Heart social profiles

Digital presence

Keystone Heart financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Keystone Heart leadership team

Management profile

Number of profiles

Profiles3 records

Keystone Heart funding detail

Funding detail

Funding overview

Funding rounds1 record

Investors2 records

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

Keystone Heart M&A and investment

M&A and investment

M&A1 record

Investments

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

Frequently asked questions about Keystone Heart

What does Keystone Heart do?

Keystone Heart develops and manufactures cerebral embolic protection medical devices used during cardiovascular procedures, including TAVR (Transcatheter Aortic Valve Replacement), intended to reduce the risk of peri-procedural stroke by capturing embolic debris. The company operates in the cerebral protection segment of the cardiovascular medical device market and expanded its portfolio through the 2020 acquisition of 510 Kardiac Devices.

When was Keystone Heart founded?

Keystone Heart was founded in 2004. It employs 11 to 50 people.

Where is Keystone Heart based?

Keystone Heart is headquartered in Herzliya, Israel, in the Middle East region.

Who are Keystone Heart's main competitors?

Broad incumbents on record are Boston Scientific, Edwards Lifesciences, Medtronic and Abbott Vascular. Emerging players are Protembis, Emboline and InspireMD. Venus Medtech is listed as a regional player.

Does Keystone Heart have an API?

No public API is recorded for Keystone Heart.

What industry is Keystone Heart in?

Keystone Heart's product category is Cerebral Embolic Protection Devices. Its primary akta.pro industry code is HLAHAFAJ, Thrombectomy, Embolic Protection & Stroke Intervention Devices, with a secondary code of HLAHAFAB, Structural Heart Valves (TAVR/SAVR) & Valve Repair. Its NAICS code is 334510 and its SIC code is 3845.

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Live signals
PR NewswireResultados alentadores conseguidos en Europa para el dispositivo de protección embólica cerebral TriGUARD 3™Keystone Heart, a subsidiary of Venus Medtech, announced that its TriGUARD 3 cerebral embolic protection device has been used in fourteen European countries with zero reported strokes since receiving CE marking in March 2020. The device is designed to minimize brain damage risks during transcatheter heart procedures like TAVI by protecting the three main vessels of the aortic arch. Physicians have confirmed the device's ease of use and effectiveness in providing optimal protection without interfering with existing TAVI systems.PR NewswireErmutigende Ergebnisse in Europa für das TriGUARD 3™ zum Schutz vor Zerebralembolie bei Transkatheter-Eingriffen am HerzenKeystone Heart Ltd., a Venus MedTech company, announced that its TriGUARD 3 cerebral embolic protection device has achieved a significant milestone in Europe, having been deployed in 14 countries since receiving CE marking in March 2020 with no physician-reported strokes. The device is designed to minimize the risk of cerebral damage during trans catheter heart procedures, including TAVI, by covering all three major cerebral aortic arch vessels. The company plans to expand commercialization efforts in 2021, focusing on major cardiac centers in Europe.PR NewswireRésultats encourageants observés en Europe pour le dispositif de protection embolique cérébrale TriGUARD 3™ lors d'interventions cardiaques transcathéterKeystone Heart Ltd, a Venus Medtech company, announced encouraging European results for its TriGUARD 3 cerebral embolic protection device, which received CE marking in March 2020 and has been used across 14 countries with no reported strokes. The device is designed to reduce brain injury risk during transcatheter cardiac procedures like TAVI by covering and protecting the three main cerebral vessels of the aortic arch. The company indicated it will continue expanding commercialization efforts throughout major structural cardiac centers in Europe in 2021.PR NewswireKeystone Heart Ltd. and InterValve Medical Inc. enter distribution agreement for balloon aortic valvuloplasty portfolioKeystone Heart Ltd. announced an exclusive distribution agreement with InterValve Medical Inc. to sell and market their V8 and TAV8 balloon aortic valvuloplasty catheters in the United States, effective March 25, 2021. The V8 and TAV8 are the only FDA-cleared aortic valvuloplasty balloon catheters with a unique 8-shaped design that more closely matches the anatomical structure of the aortic valve versus traditional cylindrical balloons. The agreement expands Keystone Heart's structural heart portfolio and strengthens its offerings for physicians performing both pre- and post-transcatheter heart valve procedures.PR NewswireKeystone Heart, una compañía Venus Medtech, anuncia el primer caso realizado con el dispositivo TriGUARD 3™Keystone Heart Ltd., a Venus Medtech company, announced the completion of the first commercial case worldwide using the TriGUARD 3™ cerebral embolic protection device during a transcatheter aortic valve implantation procedure at UMC Utrecht in the Netherlands. The device is the only CE-marked product designed to cover and protect all three cerebral vessels of the aortic arch during cardiac procedures. The company began commercializing the TriGUARD 3™ CEP device at select European TAVI centers in July 2020.PR NewswireKeystone Heart, une société de Venus Medtech, annonce la toute première utilisation commerciale du dispositif de protection embolique cérébrale TriGUARD 3™Keystone Heart Ltd., a subsidiary of Venus Medtech, announced the first commercial use of its TriGUARD 3™ cerebral embolic protection device during a TAVI procedure at UMC Utrecht in the Netherlands. The device, the only CE-marked product designed to cover all three major cerebral blood vessels, was successfully implanted by Dr. Pieter Stella. Keystone Heart began commercializing the TriGUARD 3™ in select European TAVI centers in July 2020.PR NewswireKeystone Heart, ein Unternehmen von Venus Medtech, gibt weltweit ersten kommerziellen Eingriff mit Schutzgerät TriGUARD 3™ gegen zerebrale Embolie bekanntKeystone Heart, a subsidiary of Venus Medtech, announced the completion of the world's first commercial procedure using its TriGUARD 3™ Cerebral Embolic Protection (CEP) device, performed by Dr. Pieter Stella at University Hospital Utrecht in the Netherlands during a transcatheter aortic valve implantation (TAVI). The TriGUARD 3™ is the only CE-marked device designed to cover and protect all three major cerebral aortic arch vessels, using a self-positioning nitinol frame with a dome-shaped fabric deflector introduced transfemorally. Keystone Heart began marketing the device in July 2020 through selected TAVI excellence centers in Europe, targeting the growing use of TAVI in lower-risk patient populations.PR NewswireKeystone Heart, A Venus Medtech Company, Acquires 510 Kardiac Devices, Inc.Keystone Heart, LTD., a Venus Medtech company headquartered in Israel with US operations in Tampa, Florida, has acquired 510 Kardiac Devices, Inc., a privately-held development-stage medical device company and maker of the Lim Transseptal System. The acquisition is designed to broaden Keystone Heart's portfolio and strengthen its long-term strategy of offering total package solutions for left-sided structural heart procedures including mitral valve treatment and left atrial appendage occlusion. The Lim Transseptal System is not yet cleared for US use or CE marked, but the deal provides 510 Kardiac Devices access to Keystone Heart's product development and go-to-market capabilities for US and European markets.PR NewswireKeystone Heart, una compañía Venus Medtech, adquiere 510 Kardiac Devices, Inc.Keystone Heart Ltd., a Venus Medtech company focused on structural coronary medical devices, announced on June 16, 2020 that it has acquired 510 Kardiac Devices, Inc., a private medical device company and manufacturer of the Lim Transseptal System. The Lim Transseptal System is designed for left-sided structural coronary procedures requiring a transseptal approach, including percutaneous mitral valve treatment, left atrial appendage occlusion, and electrophysiological procedures. The acquisition is intended to expand Keystone Heart's product portfolio and reinforce its long-term strategy of offering comprehensive solutions for structural coronary procedures, while enabling 510 Kardiac Devices to bring its technology to the U.S. and European markets.PR NewswireKeystone Heart, une société Venus Medtech, acquiert 510 Kardiac Devices, Inc.Keystone Heart, a subsidiary of Venus Medtech, announced the acquisition of 510 Kardiac Devices, Inc. This transaction includes the Lim Transseptal System, a medical device designed to improve efficiency and safety in left-sided structural heart procedures. The deal aims to expand Keystone Heart's product portfolio and strengthen its strategic position in the market for transseptal therapies.