HLT
The Next-generation of TAVR Technology

Transcatheter aortic valve replacement (TAVR) is among the fastest-growing segments in the cardiovascular industry. The global TAVR market is expected to rapidly grow by a compound annual growth rate of 18.30 percent during 2017-2020. This will be primarily driven by an increase in product approvals, an expansion of patient populations, and rapid adoption of minimally invasive techniques.

Early TAVR procedures were limited to patients that were either inoperable or high risk for undergoing surgery. Nonetheless, the scope of TAVR procedures has significantly expanded with the increase in the intermediate and low-risk patient population. This significant increase in patients calls for ensuring product and procedural reliability for the medical staff using the TAVR device. Furthermore, as costs related to overall healthcare grows, hospital administrations compare the long-term costs of TAVR and feel it is the preferred treatment strategy for intermediate-risk patients. As such, there is a need for systems to allow valves to be placed with consistent results, which can be easily adopted by large and small healthcare institutions.


The HLT Meridian TAVR Valve System is for Investigational use only

With its innovative technologies and procedural techniques in advancing TAVR, HLT, Inc. has positioned itself to help clients achieve better and more predictable patient outcomes that meet not only today’s needs, but the patient needs into the future. HLT is a technology and clinical-stage medical device firm and a subsidiary of the Bracco Group. It is dedicated to advancing heart valve disease therapy by developing the next-generation Meridian® Valve Platform. “We have designed a platform that is intended to improve hemodynamics, durability, and ease of use to ensure optimal performance and improve the quality of life for TAVR patients,” states David R Elizondo, SVP and General Manager at HLT.

According to Elizondo, the valve and the delivery system plays a crucial role in offering predictable results to treat patients better. The HLT® Meridian® TAVR Valve System is designed for excellent hemodynamics, durability, repositionability, and complete retrievability after assessing the final position and hemodynamics. The valve has a unique, isolated, flexible valve frame, which is designed to ensure its optimal functionality. This tissue wire form is designed to easily flex with every heartbeat to provide excellent blood flow, even in small patient annuli.

We have designed a platform that is intended to improve hemodynamics, durability, and ease of use to ensure optimal performance and improve the quality of life for TAVR patients

The flexibility is also designed to take the stress off the valve leaflets. In addition, a new tissue treatment can reduce phospholipid content and mineralization.

Unlike other valves that come with positioning limitations, Meridian is designed to assess location and performance before the final release. This can further reduce the complications and high pacemaker rates. Physicians can conduct a complete assessment of the position and hemodynamics before valve release and even recapture the valve for repositioning elsewhere. This allows the implanter precision and accuracy while optimizing each patient’s end result before releasing the valve. The valve’s unique design also allows physicians to deploy it with ease, irrespective of the patients’ anatomical differences in the aortic annulus. Additionally, Meridian’s preclinical models represent its adaptability as it anchors very well in the absence of calcified leaflets. During the TAVR procedure, there is no rapid pacing required to deploy and deliver Meridian with the automated single-operator system. This allows for precise placement, easy assessment, and reliable, reproducible results. It may also reduce procedural time and resources, reducing healthcare costs, both short-term and long-term.

HLT’s platform is composed of materials and components that are clinically-proven and widely accepted. Its leaflets are made of treated porcine pericardium, which is an extremely durable material with reduced phospholipids and mineralization, thus, promising better performing valves with higher longevity. The valve frame is nitinol-based, which is highly resistant to corrosion and fatigue. What makes HLT and its products even more competent is its fully integrated manufacturing process, where it procures all components and conducts the treatment, testing, and inspection internally.

Apart from its revolutionary device in the development and clinical trial stage, HLT has a unique advantage with its staff and leadership with extensive TAVR experience. The company has a highly skilled team and a robust intellectual property portfolio. HLT’s technology can apply to TAVR and other structural heart applications. With this repository of expertise and innovation, HLT is looking forward to broadening its studies beyond preclinical and clinical trials and commercializing its product globally in the coming years.