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Supira Medical

Full company profile

uuid00009ik

Namestring
Supira Medical
Legal namestring
Supira Medical, Inc.
Company typeenum
Private
Founded yearint
2020
Descriptiontext

Supira Medical, Inc. is a clinical-stage medical device company headquartered in Los Gatos, California, developing the Supira System, a next-generation percutaneous ventricular assist device (pVAD) for temporary mechanical circulatory support. The device is designed around a 10 French low-profile architecture that delivers high continuous flow and incorporates multiple integrated sensors for real-time aortic and ventricular pressure monitoring, intended to reduce the vascular complications associated with larger existing pVADs while enabling patient mobility through percutaneous axillary access. The Supira System is being developed as a single device platform targeting two primary indications: hemodynamic support during high-risk percutaneous coronary intervention (HRPCI) and treatment of cardiogenic shock.

The company is currently pre-commercial, with the Supira System designated as an investigational device not approved for sale in the U.S. or anywhere in the world. Clinical development has progressed from first-in-human studies initiated in Paraguay in September 2022, through a U.S. Early Feasibility Study (SUPPORT I, 15 patients across 4 sites, enrollment completed by March 2025), to FDA approval in April 2026 of the SUPPORT II Pivotal Trial, which is designed to enroll up to 385 patients across up to 40 U.S. sites in support of a future PMA submission. The company has treated 99 patients cumulatively as of April 2026 across its clinical programs.

Commercially, Supira Medical plans to generate revenue through direct sales of the Supira System to U.S. hospitals and interventional cardiology centers upon regulatory approval, with enterprise sales targeting cath labs performing high-risk PCI and treating cardiogenic shock patients. The company has raised approximately $225 million across five financing rounds (Series B through E), with the most recent $120M Series E in March 2025 led by Novo Holdings and Qatar Investment Authority. Supira operates as a portfolio company of Shifamed, LLC, a medical innovation hub founded by Amr Salahieh, and is led by President and CEO Dr. Nitin Salunke.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
51–100
akta.pro rankint
HeadquartersLos Gatos, United States
HQ citystring
Los Gatos
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices2 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
percutaneous ventricular assist device, mechanical circulatory support, high-risk PCI devices, cardiogenic shock treatment, interventional cardiology devices
Industry2 codes
1Mechanical Circulatory Support (VAD, IABP, ECMO)
CodeHLAHAFAGPrimaryYes
2Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation)
CodeHLAHAFALPrimaryNo
NAICS code1 code
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
SIC code2 codes
  • Electromedical & Electrotherapeutic Apparatus3845
  • Surgical & Medical Instruments & Apparatus3841
Product category
Percutaneous Ventricular Assist Devices (Mechanical Circulatory Support)
Social media profiles1 record
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1Medical Device Sales
TypeHardware Sales
Description

Supira Medical is a clinical-stage company developing a percutaneous ventricular assist device. The Supira System is currently an investigational device not approved for sale in the U.S. or anywhere in the world. Revenue will be generated through device sales to hospitals and medical centers upon regulatory approval.

supiramedical.com
Marketing channels3 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components6 values
Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 record
1Supira System
Description

Next-generation percutaneous ventricular assist device (pVAD) designed for high-risk PCI and cardiogenic shock patients with a novel low profile, high continuous flow design featuring 10F profile and real-time pressure sensors.

supiramedical.com
Core offering1 text field

Supira Medical develops the Supira System, a next-generation percutaneous ventricular assist device (pVAD) featuring a 10 French low-profile, high continuous flow design with integrated real-time pressure sensors. It is engineered to provide temporary mechanical circulatory support for patients undergoing high-risk percutaneous coronary interventions (HRPCI) and for patients experiencing cardiogenic shock. The product is currently investigational and not approved for sale in any market.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 3 values shown
  • 99 patients treated with the Supira System as of April 2026
+2 more records
Product overview1 text field

Supira Medical is a clinical-stage company developing a single unified product platform: the Supira System, a next-generation percutaneous ventricular assist device (pVAD). The Supira System is a low-profile (10F), high-flow mechanical circulatory support device designed for temporary hemodynamic support during high-risk percutaneous coronary interventions (HRPCI) and for patients experiencing cardiogenic shock. The system features integrated sensors for real-time aortic and ventricular pressure monitoring. The company is currently conducting clinical studies (SUPPORT I Early Feasibility Study and SUPPORT II Pivotal Trial) to support FDA PMA approval for U.S. market entry. The Supira System is an investigational device and is not approved for sale in the U.S. or anywhere in the world.

Product and service1 record
1Supira System
CategoryPercutaneous Ventricular Assist Devices (Mechanical Circulatory Support)
Description

Next-generation percutaneous ventricular assist device (pVAD) featuring a 10 French low-profile, high continuous flow design with integrated real-time aortic and ventricular pressure sensors. Designed to provide full hemodynamic support during high-risk percutaneous coronary interventions (HRPCI) and for cardiogenic shock patients via a single device platform. Intended for use by interventional cardiologists in hospital cath labs and cardiac care settings. The Supira System is currently an investigational device and is not approved for sale in the U.S. or anywhere in the world.

Scale indicator6 records

Each record includes

Type, Value, Description, Source

Partnership3 partners
1D. Keith Grossman
Strategic tierCoreTypeOthersAnnounced on2026-04-08
Description

Appointed to Supira Medical's Board of Directors in April 2026. Brings 40 years of leadership experience in medical technology industry, including foundational role in mechanical circulatory support space.

supiramedical.com
2Dr. Christopher Shen
Strategic tierCoreTypeOthersAnnounced on2025-03-26
Description

Partner at Novo Holdings US, joined Supira's Board of Directors as part of the Series E financing.

supiramedical.com
Strategic tierFlagshipTypeStrategic or Co-development PartnerAnnounced on2025-03-26
Description

Supira Medical is a portfolio company of Shifamed, a medical innovation hub founded by serial entrepreneur Amr Salahieh. Shifamed provides development support and resources for portfolio companies.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Abiomed's Impella is the dominant and most established percutaneous ventricular assist device used for HRPCI and cardiogenic shock — Supira's direct head-to-head competitor in cath-lab mechanical circulatory support.

TypeDirect peer
Description

Israel-based developer of a low-profile, high-flow transcatheter ventricular assist device aimed at the same HRPCI/cardiogenic shock indications; the closest emerging direct competitor to Supira's design philosophy.

TypeDirect peer
Description

German developer of the Reitan Catheter Pump, a percutaneous mechanical circulatory support device for high-risk PCI — directly comparable catheter-based platform targeting the same patient population.

TypeDirect peer
Description

Through the TandemLife acquisition (TandemHeart), LivaNova markets a percutaneous ventricular assist system for short-term mechanical circulatory support, making it a direct competitor to Supira in the HRPCI/CS space.

TypeDirect peer
Description

French developer of the ICOMS (Implantable Cardiac Output Management System), a catheter-based mechanical circulatory support platform with overlapping ambitions in temporary and durable heart failure support.

TypeEmerging player
Description

Developer of Aortix, a percutaneous mechanical circulatory support pump for cardiogenic shock and HF; overlaps with Supira in catheter-based ventricular support but with a different anatomical placement.

TypeDirect peer
Description

Developer of the EVAHEART2 left ventricular assist system, including a percutaneous next-generation platform aimed at short-term mechanical circulatory support in cardiac surgery and HF patients.

TypeEmerging player
Description

Early-stage developer of a catheter-based mechanical circulatory support device; competes with Supira in the catheter-pump category targeting HRPCI and acute HF patients.

TypeEmerging player
Description

Developer of a unique undulating-membrane LVAD technology with both durable and short-term mechanical circulatory support programs; a thematic peer in the next-generation MCS space.

TypeEmerging player
Description

Developer of the AccuCinch ventricular restoration system for heart failure patients — adjacent mechanical therapy approach targeting a similar interventional cardiology and HF specialist customer base.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers4 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

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

Feature4 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles5 records

Each record includes

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

No data
Compliance1 record

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds5 records

Each record includes

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

Investors10 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&A

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 →

Supira Medical

Percutaneous Ventricular Assist Devices (Mechanical Circulatory Support)supiramedical.com

What Supira Medical does

Supira Medical, Inc. is a clinical-stage medical device company headquartered in Los Gatos, California, developing the Supira System, a next-generation percutaneous ventricular assist device (pVAD) for temporary mechanical circulatory support. The device is designed around a 10 French low-profile architecture that delivers high continuous flow and incorporates multiple integrated sensors for real-time aortic and ventricular pressure monitoring, intended to reduce the vascular complications associated with larger existing pVADs while enabling patient mobility through percutaneous axillary access. The Supira System is being developed as a single device platform targeting two primary indications: hemodynamic support during high-risk percutaneous coronary intervention (HRPCI) and treatment of cardiogenic shock.

The company is currently pre-commercial, with the Supira System designated as an investigational device not approved for sale in the U.S. or anywhere in the world. Clinical development has progressed from first-in-human studies initiated in Paraguay in September 2022, through a U.S. Early Feasibility Study (SUPPORT I, 15 patients across 4 sites, enrollment completed by March 2025), to FDA approval in April 2026 of the SUPPORT II Pivotal Trial, which is designed to enroll up to 385 patients across up to 40 U.S. sites in support of a future PMA submission. The company has treated 99 patients cumulatively as of April 2026 across its clinical programs.

Commercially, Supira Medical plans to generate revenue through direct sales of the Supira System to U.S. hospitals and interventional cardiology centers upon regulatory approval, with enterprise sales targeting cath labs performing high-risk PCI and treating cardiogenic shock patients. The company has raised approximately $225 million across five financing rounds (Series B through E), with the most recent $120M Series E in March 2025 led by Novo Holdings and Qatar Investment Authority. Supira operates as a portfolio company of Shifamed, LLC, a medical innovation hub founded by Amr Salahieh, and is led by President and CEO Dr. Nitin Salunke.

Supira Medical firmographics

Firmographics
Name
Supira Medical
Legal name
Supira Medical, Inc.
Website
https://supiramedical.com
Company type
Private
Founded year
2020
Operating status
Operating
Headcount range
51–100 employees
Ownership category
akta.pro rank

Supira Medical industry classification

Industry
Product category
Percutaneous Ventricular Assist Devices (Mechanical Circulatory Support)
NAICS
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
SIC
Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)
akta.pro primary industry
Mechanical Circulatory Support (VAD, IABP, ECMO) (HLAHAFAG)
akta.pro secondary industry
Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

Keywords

  • Percutaneous ventricular assist device
  • Mechanical circulatory support
  • High-risk PCI devices
  • Cardiogenic shock treatment
  • Interventional cardiology devices

Where Supira Medical is headquartered

Location

Headquarters

HQ city
Los Gatos
HQ country
United States
HQ region
North America

Offices2 records

Markets served

Supira Medical business model

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

Revenue model

  1. Medical Device Sales: Supira Medical is a clinical-stage company developing a percutaneous ventricular assist device. The Supira System is currently an investigational device not approved for sale in the U.S. or anywhere in the world. Revenue will be generated through device sales to hospitals and medical centers upon regulatory approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Supira Medical product offering

Product offering

Core offering

Supira Medical develops the Supira System, a next-generation percutaneous ventricular assist device (pVAD) featuring a 10 French low-profile, high continuous flow design with integrated real-time pressure sensors. It is engineered to provide temporary mechanical circulatory support for patients undergoing high-risk percutaneous coronary interventions (HRPCI) and for patients experiencing cardiogenic shock. The product is currently investigational and not approved for sale in any market.

Product overview

Supira Medical is a clinical-stage company developing a single unified product platform: the Supira System, a next-generation percutaneous ventricular assist device (pVAD). The Supira System is a low-profile (10F), high-flow mechanical circulatory support device designed for temporary hemodynamic support during high-risk percutaneous coronary interventions (HRPCI) and for patients experiencing cardiogenic shock. The system features integrated sensors for real-time aortic and ventricular pressure monitoring. The company is currently conducting clinical studies (SUPPORT I Early Feasibility Study and SUPPORT II Pivotal Trial) to support FDA PMA approval for U.S. market entry. The Supira System is an investigational device and is not approved for sale in the U.S. or anywhere in the world.

Differentiator

Problem solved

Functional benefit

Brands

  • Supira System: Next-generation percutaneous ventricular assist device (pVAD) designed for high-risk PCI and cardiogenic shock patients with a novel low profile, high continuous flow design featuring 10F profile and real-time pressure sensors.

Products and services

  • Supira System Next-generation percutaneous ventricular assist device (pVAD) featuring a 10 French low-profile, high continuous flow design with integrated real-time aortic and ventricular pressure sensors. Designed to provide full hemodynamic support during high-risk percutaneous coronary interventions (HRPCI) and for cardiogenic shock patients via a single device platform. Intended for use by interventional cardiologists in hospital cath labs and cardiac care settings. The Supira System is currently an investigational device and is not approved for sale in the U.S. or anywhere in the world.

Quantifiable outcome

  • 99 patients treated with the Supira System as of April 2026
  • +2 more outcomes

Companies that use Supira Medical

Customer profile

Named customers4 records

Segments2 records

Ideal customer profiles1 record

Supira Medical technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature4 records

Supira Medical partnerships and signals

Strategic signal

Partnerships

Three partnerships are on record, tiered core and flagship.

  • D. Keith GrossmancoreOthers · 8 April 2026Appointed to Supira Medical's Board of Directors in April 2026. Brings 40 years of leadership experience in medical technology industry, including foundational role in mechanical circulatory support space.
  • Dr. Christopher ShencoreOthers · 26 March 2025Partner at Novo Holdings US, joined Supira's Board of Directors as part of the Series E financing.
  • ShifamedflagshipStrategic or Co-development Partner · 26 March 2025Supira Medical is a portfolio company of Shifamed, a medical innovation hub founded by serial entrepreneur Amr Salahieh. Shifamed provides development support and resources for portfolio companies.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Supira Medical competitors and assessment

Company assessment

Direct peers

  • Abiomed (Johnson & Johnson MedTech): Abiomed's Impella is the dominant and most established percutaneous ventricular assist device used for HRPCI and cardiogenic shock — Supira's direct head-to-head competitor in cath-lab mechanical circulatory support.
  • Magenta Medical: Israel-based developer of a low-profile, high-flow transcatheter ventricular assist device aimed at the same HRPCI/cardiogenic shock indications; the closest emerging direct competitor to Supira's design philosophy.
  • CardioBridge GmbH: German developer of the Reitan Catheter Pump, a percutaneous mechanical circulatory support device for high-risk PCI — directly comparable catheter-based platform targeting the same patient population.
  • LivaNova: Through the TandemLife acquisition (TandemHeart), LivaNova markets a percutaneous ventricular assist system for short-term mechanical circulatory support, making it a direct competitor to Supira in the HRPCI/CS space.
  • FineHeart: French developer of the ICOMS (Implantable Cardiac Output Management System), a catheter-based mechanical circulatory support platform with overlapping ambitions in temporary and durable heart failure support.
  • Evaheart Inc. Developer of the EVAHEART2 left ventricular assist system, including a percutaneous next-generation platform aimed at short-term mechanical circulatory support in cardiac surgery and HF patients.

Emerging players

  • Procyrion: Developer of Aortix, a percutaneous mechanical circulatory support pump for cardiogenic shock and HF; overlaps with Supira in catheter-based ventricular support but with a different anatomical placement.
  • Windmill Cardiovascular Systems: Early-stage developer of a catheter-based mechanical circulatory support device; competes with Supira in the catheter-pump category targeting HRPCI and acute HF patients.
  • CorWave: Developer of a unique undulating-membrane LVAD technology with both durable and short-term mechanical circulatory support programs; a thematic peer in the next-generation MCS space.
  • Ancora Heart: Developer of the AccuCinch ventricular restoration system for heart failure patients — adjacent mechanical therapy approach targeting a similar interventional cardiology and HF specialist customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Supira Medical social profiles

Digital presence

Supira Medical compliance and trust

Trust signal

Compliance1 record

Supira Medical financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Supira Medical leadership team

Management profile

Number of profiles

Profiles5 records

Supira Medical funding detail

Funding detail

Funding overview

Funding rounds5 records

Investors10 records

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

Supira Medical M&A and investment

M&A and investment

M&A

Investments

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

Frequently asked questions about Supira Medical

What does Supira Medical do?

Supira Medical develops the Supira System, a next-generation percutaneous ventricular assist device (pVAD) featuring a 10 French low-profile, high continuous flow design with integrated real-time pressure sensors. It is engineered to provide temporary mechanical circulatory support for patients undergoing high-risk percutaneous coronary interventions (HRPCI) and for patients experiencing cardiogenic shock. The product is currently investigational and not approved for sale in any market.

Is Supira Medical a public or private company?

Supira Medical is a private company. It is classified as venture growth investor backed and is currently operating.

When was Supira Medical founded?

Supira Medical was founded in 2020. It employs 51 to 100 people.

Where is Supira Medical based?

Supira Medical is headquartered in Los Gatos, United States, in the North America region.

How does Supira Medical make money?

One revenue line is on record: medical Device Sales.

Who are Supira Medical's main competitors?

Direct peers on record are Abiomed (Johnson & Johnson MedTech), Magenta Medical, CardioBridge GmbH, LivaNova, FineHeart and Evaheart Inc.. Emerging players are Procyrion, Windmill Cardiovascular Systems, CorWave and Ancora Heart.

Does Supira Medical have an API?

No public API is recorded for Supira Medical.

What industry is Supira Medical in?

Supira Medical's product category is Percutaneous Ventricular Assist Devices (Mechanical Circulatory Support). Its primary akta.pro industry code is HLAHAFAG, Mechanical Circulatory Support (VAD, IABP, ECMO), with a secondary code of HLAHAFAL, Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation). Its NAICS code is 334510 and its SIC code is 3845.

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Live signals
Medical Device and Diagnostic industryNew Heart Pump Challenges J&J's ImpellaSupira Medical is preparing to conduct an investigational device exemption study in the United States for its new Supira pVAD, a percutaneous ventricular assist device designed to challenge Johnson & Johnson's market-leading Impella heart pumps. The Supira device utilizes a smaller 10 French introducer sheath and higher blood flow capacity of 5.5 liters per minute compared to the Impella's 3.5 liters, aiming to reduce complications and broaden the eligible patient population. This development follows Supira Medical's recent $120 million Series E financing led by Novo Holdings and Qatar Investment Authority.PR NewswireSupira Medical объявляет об одобрении FDA базового исследования SUPPORT II, достижениях в области кардиогенного шока и назначении Д. Кита Гроссмана (D. Keith Grossman) в Совет директоровSupira Medical received FDA approval to initiate the SUPPORT II pivotal trial, a prospective randomized controlled study of up to 385 patients at 40 U.S. centers evaluating the company's next-generation percutaneous ventricular assist device (pVAD) in high-risk percutaneous coronary interventions, with the trial designed to support a future PMA submission. The company also reported advances in cardiogenic shock treatment using a 10Fr pVAD with percutaneous axillary access enabling patient mobility, and appointed 40-year medical device industry veteran D. Keith Grossman as an independent board member to support commercial scaling efforts.PR NewswireSupira Medical oznamuje schválenie kľúčovej štúdie SUPPORT II od FDA, pokroky v liečbe kardiogénneho šoku a menovanie D. Keitha Grossmana do predstavenstvaSupira Medical received FDA approval to initiate the SUPPORT II pivotal study for its next-generation percutaneous ventricular assist device (pVAD) in high-risk percutaneous coronary intervention (HRPCI) patients. The randomized controlled trial will enroll up to 385 patients across 40 U.S. centers and is designed to support a future PMA submission for U.S. market entry. The company also announced advances in treating cardiogenic shock patients and appointed medical technology veteran D. Keith Grossman to its board of directors.MassDeviceSupira gets FDA green light to conduct ventricular assist device studySupira Medical received FDA approval to initiate the SUPPORT II pivotal trial for its next-generation percutaneous ventricular assist device (pVAD) in patients undergoing high-risk coronary interventions. The company, which raised $120 million last year, plans to enroll up to 385 patients at 40 U.S. sites to support a future premarket approval submission. This milestone is viewed as a critical step toward U.S. market entry and potential competition with Johnson & Johnson's Abiomed.AD HOC NEWSSupira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, aSupira Medical, Inc. announced that the U.S. FDA has approved the initiation of the SUPPORT II pivotal trial to evaluate its next-generation percutaneous ventricular assist device in high-risk coronary intervention patients. The company also highlighted clinical advances in treating cardiogenic shock using axillary access and appointed D. Keith Grossman to its board of directors to support commercial scaling.PR NewswireSupira Medical annonce l'approbation par la FDA de l'essai pivot SUPPORT II, Advances in Cardiogenic Shock, et la nomination de D. Keith Grossman au conseil d'administration.Supira Medical, a clinical-stage company developing a next-generation percutaneous ventricular assist device (pVAD), received FDA approval to launch the SUPPORT II pivotal trial, a prospective randomized controlled study designed to support a future premarket approval (PMA) application. The trial will enroll up to 385 patients at up to 40 sites across the United States, evaluating the safety and efficacy of the device in patients undergoing high-risk percutaneous coronary intervention (HRPCI). The company also announced the appointment of D. Keith Grossman, a 40-year medical device industry veteran, as an independent member of its board of directors.PR NewswireSupira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, and Appointment of D. Keith Grossman to Board of DirectorsSupira Medical announced FDA approval to initiate the SUPPORT II Pivotal Trial for its next-generation percutaneous ventricular assist device, designed to support a future PMA submission and U.S. market entry. The randomized controlled trial will enroll up to 385 patients at up to 40 U.S. sites to assess safety and efficacy in high-risk percutaneous coronary intervention procedures. The company also appointed D. Keith Grossman, a 40-year medical device industry veteran, to its Board of Directors to support scaling toward market readiness.PR NewswireSupira Medical ogłasza zatwierdzenie przez Agencję ds. Żywności i Leków kluczowego badania SUPPORT II, postępy w leczeniu wstrząsu kardiogennego oraz powołanie D. Keitha Grossmana do rady dyrektorówSupira Medical announced FDA approval to begin the SUPPORT II pivotal trial to support its planned Premarket Approval (PMA) application for a next-generation percutaneous ventricular assist device (pVAD), marking a significant step toward US market entry. The randomized controlled trial will enroll up to 385 patients at up to 40 US centers, evaluating the device's safety and efficacy in high-risk percutaneous coronary intervention procedures. The company also reported clinical advances in treating cardiogenic shock and appointed industry veteran D. Keith Grossman to its board of directors.PR NewswireSupira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, and Appointment of D. Keith Grossman to Board of DirectorsSupira Medical announced FDA approval to initiate the SUPPORT II Pivotal Trial, a clinical study assessing the safety and efficacy of its next-generation pVAD device for high-risk PCI patients in the U.S. The milestone aims to support future market approval and improve treatment options for cardiogenic shock and high-risk PCI procedures. Additionally, D. Keith Grossman was appointed to the company's board to support growth and market readiness.PR NewswireSupira Medical gibt FDA-Zulassung für SUPPORT II Pivotalstudie, Fortschritte bei kardiogenem Schock und Ernennung von D. Keith Grossman zum Vorstandsmitglied bekanntSupira Medical received FDA approval to begin the SUPPORT II pivotal study, a prospective randomized controlled trial evaluating the safety and efficacy of its next-generation percutaneous ventricular assist device (pVAD) in patients undergoing high-risk percutaneous coronary intervention, with up to 385 patients enrolled across up to 40 sites in the USA. The company also reported its first series of cardiogenic shock patients treated using a percutaneous axillary approach with an active 10Fr pVAD, and the appointment of MedTech veteran D. Keith Grossman to its board of directors. The Supira System remains an investigational device not approved for sale in the USA or globally, having been used in 99 patients to date.