PRODUCTS

Medical Devices for Cardiovascular Diagnostics and Interventional Procedures

HEART DISEASE, PCI & THE MARKET

The U.S. Center for Disease Control and Prevention estimates that the treatment of heart disease in the U.S. alone costs the nation $200 billion per year and 121 million people have cardiac issues. Cardiovascular Disease (CVD), a form of heart disease, is the number one cause of death globally. Interventional cardiology most often treats CVD by performing a percutaneous coronary intervention (PCI) procedure, in which balloon angioplasty will clear the blockage in an artery, and implanting a stent will keep the artery open for proper blood flow.

Based on a review of medical journal articles, public databases, industry knowledge, and independent market research, Accumed Radial believes the following to be a reasonable approximation of the total annual U.S. market size: 2.1 million cardiac catheterization procedures total, of which 965,000 are PCI procedures. Transradial access (TRA) is one way of conducting a catheterization procedure. It is used approximately 45% of the time and is expected to grow to 70% or higher in the next few years.

“According to the latest interventional cardiology procedural analysis by iData Research, over 965,000 angioplasties are done each year in the United States. An angioplasty, also known as percutaneous coronary intervention (PCI) . . .”

iData Research – September 2018

OUR PRODUCTS

Accumed Radial has three products in development for this area; vessel caliper, hemostasis band and Next Generation Guide Extension.

Accumed Radial Vessel Caliper

The Accumed Vessel Caliper is a medical device used to make intra-vascular length measurements. It is a convenient and efficient tool used during catheterization procedures of the coronary, carotid, renal or peripheral vasculature.

Vessel Caliper Features and benefits

Accuracy testing shows a high correlation to intravascular ultrasound (IVUS) measurements.
Does not require additional devices to be inserted for making the measurement, other than a catheter and guidewire already in use.
Faster than quantitative coronary analysis (QCA).
Valuable for tight measurements between arterial branches.
Measures long lesion lengths that are difficult to estimate.
Valuable information for stent applications.
Interfaces with the majority of y-connectors, catheters (hubs), and guidewires currently on the market and in use today .
Class I medical device per FDA classification and 510(k) exempt.
Provided sterile and disposable for one-time use.

Hemostasis Band

The Accumed Radial Hemostasis Band is a pressure wound dressing. It is used to close the access site puncture wound on the wrist when the TRA procedure is complete. There are several competitors for hemostasis band products, the largest being the TR Band by Terumo Medical. Because of the competition status, Accumed Radial is looking to develop a unique and innovative hemostasis band to give us a competitive advantage.

Next Generation Guide Extension

The Next Generation Guide Extension is the next generation product for a guide extension. In Interventional Cardiology (IC), guide extensions are a valuable tool. The Next Generation Guide Extension is a specialized tool to allow stent delivery and deployment past tortuous and calcified sections of coronary arteries. The Next Generation Guide Extension will bring significant advantages to the IC market by helping deliver stents to blood vessels near the heart much more easily.