WELCOME TO INSIGHTRA MEDICAL INC

A medical device used to temporarily support heart function

Your Intra-Aortic Balloon Catheter Specialists
Since our inception in 2001, Insightra has been at the forefront of cardiovascular medical device manufacturing, driven by a steadfast commitment to quality and innovation.
At the heart of our portfolio is the Ultra 7Fr Intra-Aortic Balloon Catheter, a testament to our dedication to advancing cardiovascular interventions. As one of only three FDA-approved global manufacturers for IABP Catheters, Insightra stands out as a beacon of excellence in the industry.
What sets us apart is our singular focus on IABP Catheters. While others may diversify, we remain dedicated to perfecting this crucial technology. This specialization allows us to channel all our resources and expertise into delivering the best possible solutions for patients and clinicians alike.
Insightra is not just a manufacturer; we’re a market leader. Through continuous investment in production capacity and relentless pursuit of excellence, we’ve achieved unparalleled success in numerous global markets. In fact, our market shares exceed 40% in many of our historic markets, solidifying our position as the go-to choice for healthcare professionals worldwide.

OUR COMPANY HISTORY

2001
Founded in Irvine, California, as a trading company specializing in cardiovascular products
2007
Received CE Approval for the Insightra Ultra 7Fr IAB Catheter, marking a significant milestone in product validation and market access and the launch of Insightra Medical Inc. as manufacturer for IABP Catheters
2009
Achieved FDA Approval for the Insightra Ultra 7Fr IAB Catheter, solidifying its safety and efficacy for use in the United States
2010
Successfully launched the Insightra Ultra 7Fr IAB Catheter in India, expanding global reach and accessibility to life-saving medical technology
2015
Private Equity Investors Baird Capital and Tekla Capital Management lead majority acquisition of Insightra Medical shares, fueling growth and strategic development initiatives
2017
GPB Capital acquires Insightra Medical in a corporate restructuring process, accompanied by the relocation of company headquarters from Irvine, California to Clarksville, Tennessee, signaling a new chapter of expansion and operational optimization
2021
Insightra Medical acquired by Mundomedis FZCO Dubai, a family-owned company, leading to the relocation of the global administrative and marketing headquarter to Dubai. While Quality Control and key administrative functions remain in Clarksville, Tennessee, the move signifies a broader global footprint and strategic alignment with international markets
2023
Doubled production capacity for IAB production at the Nagoya, Japan, plant, enhancing manufacturing capabilities to meet growing demand and ensure product availability worldwide
2024
Insightra Medical enters numerous new countries, while the Insightra Ultra 7Fr IAB Catheter emerges as a market leader in many markets, boasting significant market share in units sold and reaffirming its position as the preferred choice among healthcare professionals

OUR FACILITIES

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OUR GLOBAL
SALES NETWORK

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OUR PRODUCTS

Ultra 7FR IAB Catheter Kit

  • Actual 7Fr catheter that can be used through common Cath Lab 7Fr sheaths
  • Unique V-Hub allows comparative inflation/deflation response time as fiber optic and 8Fr devices
  • Available in 3 sizes – 40cc, 35cc, and 30cc
  • All kits come with Arrow and Datascope adaptor sets ensuring compatibility with consoles
  • FDA cleared since 2009
More Details
The Ultra 7FR IAB Catheter Kit is depicted as a compact, sterile package, with its contents neatly organized within. The image showcases the catheter kit's main components: a slender, flexible catheter, a hub assembly, and accompanying accessories.

OUR QUALITY

Experience Unmatched Longetivity

Our IABP catheters boast a remarkable 5-year shelf life, surpassing the industry standard of 3 years.

Rigorous Testing Ensures Reliability

Prior to shipment, each IABP catheter undergoes an exhaustive 50,000 inflation cycles of testing, guaranteeing unparalleled durability and performance

Unrivaled Quality
Assurance

With a steadfast commitment to high quality standards, our product has maintained an impeccable record of 0 recalls over the past 15 years. Our dedication has also ensured a complaint rate of less than 0.01%, setting us apart as a beacon of reliability and excellence.

Trusted by the
FDA

Since 2009, our IABP catheters have been cleared by the FDA, demonstrating our unwavering adherence to regulatory standards and commitment to safety.

Optimized Design for Enhanced Efficiency

Featuring a real 7Fr construction, our catheters are thinner than those of our competitors, minimizing obstruction to blood flow—particularly crucial for smaller patients.

8Fr Response Performance
in a 7Fr Device

Our large central lumen diameter facilitates faster gas shuttling for enhanced performance.

Seamless
Compatibility

Our catheters seamlessly integrate with all Arrow and Datascope pumps, ensuring effortless compatibility and versatility for medical professionals.

Innovative Patented Technology

Experience smoother operations with our patented V-Hub, designed to reduce turbulence and enhance gas flow into the catheter, ensuring optimal efficiency and patient care.

PRODUCT RESOURCES

Product Brochure
Instructions For Use (IFU)
Operator Presentation
IABP Console Compatibility Certificate

CONTACT US