Cardiva Medical, Inc. was a medical technology company specializing in the design, development, and commercialization of vascular access management products. Founded in 2002 and headquartered in Santa Clara, California, USA, the company???s core mission was to transform vascular closure for the benefit of patients, hospitals, and physicians. Its innovations addressed the critical need for safe and rapid hemostasis following percutaneous catheterization procedures, particularly in the high-growth fields of interventional cardiology, peripheral vascular intervention, and electrophysiology.
The company???s market focus was on improving clinical outcomes and enhancing hospital workflow by offering alternatives to the traditional, time-consuming, and complication-prone manual compression method for closing arterial and venous access sites. Cardiva???s technologies utilized a catheter-based delivery system to place a collagen-based sealant patch outside the vessel, a method designed to promote rapid, natural clot formation and vessel healing.
Cardiva Medical was acquired by Haemonetics Corporation in a transaction valued at $510 million, which was announced in January 2021 and completed shortly thereafter. The acquisition integrated Cardiva???s vascular closure portfolio into Haemonetics??? hospital offerings, significantly expanding the acquirer???s presence in the interventional cardiology and electrophysiology markets.
Products and Services
The product portfolio of Cardiva Medical, Inc. centered on its proprietary VASCADE® family of vascular closure devices. These devices leverage a unique delivery system involving a small, collapsible disc and a resorbable collagen patch. The collagen patch expands when hydrated and is absorbed by the body as the wound heals, providing both mechanical and physiologic hemostasis.
VASCADE® Vascular Closure System
Primary Function: The VASCADE® system is a catheter-based device indicated for the safe and rapid closure of femoral arterial and venous access sites following diagnostic and interventional procedures that utilize 5-7 French (F) access sheaths.
Technology: It utilizes an extravascular, bioabsorbable collagen patch that works in conjunction with a proprietary collapsible disc to secure the access site.
Clinical Evidence: The device gained notable recognition for its clinical performance. In the prospective, multi-center, randomized, controlled clinical trial known as RESPECT, VASCADE® was the only marketed closure system at the time clinically proven to demonstrate a statistically significant reduction in access site complications compared to the existing standard of care (manual compression). This evidence supported claims of improved patient safety and reduced complications.
Market Position: It was positioned as a simple, safe, and effective solution for small-bore femoral arterial and venous closure, aimed at improving patient comfort and mobility while increasing workflow efficiency in the catheterization lab.
VASCADE MVP® Venous Vascular Closure System
Primary Function: The VASCADE MVP® system is a specialized venous vascular closure system designed specifically for the unique needs of Electrophysiology (EP) procedures, which often require multiple venous access sites in the femoral region. It is indicated for "mid-bore" multi-access femoral venous closure.
Specific Indication: It holds the distinction of being the only FDA-approved closure device for use following cardiac ablation procedures that necessitate two or more access sites within the same vessel.
Clinical Evidence: The efficacy and performance of VASCADE MVP® were established in the multi-center, randomized, controlled clinical trial called AMBULATE. This trial, which focused on EP patients, clinically proved and labeled the device to improve workflow by enabling earlier patient ambulation compared to traditional compression techniques.
Market Position: The product immediately expanded Cardiva???s influence into the fast-growing EP market, providing physicians with a purpose-built tool for more complex, multi-site closure scenarios associated with procedures like cardiac ablation.
Other Early Products
Prior to the VASCADE line, Cardiva also introduced products like the Boomerang® Wire System in 2005 and the Catalyst III system in 2009. The Boomerang® system was an early entry into the vessel closure market demonstrating ease-of-use and safety. The Catalyst III system was coated with protamine sulfate to neutralize heparin in the tissue tract, facilitating hemostasis in anticoagulated patients. These products preceded the VASCADE line, which became the company's flagship offering.
Services and Value Proposition
Cardiva Medical's core value proposition was built on delivering technology that directly addressed clinical and economic challenges in hospitals.
Improved Patient Outcomes: The clinical data, particularly from the RESPECT and AMBULATE trials, demonstrated the VASCADE portfolio's ability to reduce access site complications and improve the patient experience by allowing for earlier ambulation and discharge.
Enhanced Hospital Workflow: By facilitating rapid hemostasis, the devices helped to shorten the time patients spent on bed rest after a procedure. This improvement in patient management translates to increased throughput and efficiency in the cath lab and recovery units, contributing to hospital cost savings.
Performance Guarantee: Demonstrating its confidence in the VASCADE® system, the company offered a unique value-based purchasing program called the VASCADE® Performance Guarantee. This program offered financial reimbursement to hospitals in the event of a complication deemed to be the result of the VASCADE device, underscoring their commitment to exceptional outcomes.
Regulatory Achievements: The VASCADE® system received its PMA approval from the FDA in 2013, a significant milestone affirming the technology???s safety and effectiveness.
The company's success in developing and commercializing its vascular closure systems led to its acquisition, confirming its role as a key innovator in the specialized field of vascular access management within the broader MedTech sector.
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