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Medtronic Enters the FFR and IVUS Technology Field With ACIST Co-Promotion Agreement
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ACIST Navvus FFR Catheter
ACIST Navvus FFR Catheter
August 4, 2014 -- Today Medtronic, Inc. (NYSE: MDT) and ACIST Medical Systems, Inc., a Bracco Group company, announced a strategic agreement to bring ACIST's FFR and IVUS products into U.S. cath labs. This collaboration marks the first time a major stent manufacturer will offer both FFR and IVUS technologies.

FFR (Fractional Flow Reserve) is a functional measurement system, used to help determine whether or not stenting a blockage will provide benefit to the patient. The efficacy of FFR has been proven over many clinical trials such as FAME and FAME II. IVUS (IntraVascular UltraSound) is an imaging modality, which can be used to improve accuracy of stent placement and to assure that the stent has been expanded optimally (underexpansion of stents has been associated with increased restenosis). These technologies are explained in detail in Angioplasty.Org's Intravascular Guidance Center.

Currently St. Jude Medical markets their FFR system, along with an OCT high resolution imaging modality. Some physicians feel that OCT is a more accurate imaging tool than IVUS. It is definitely a higher resolution image of the interior arterial surface. However, IVUS has the ability to image beyond the surface of the arterial wall, which can be beneficial in targeting diseased or calcified segments of the artery. IVUS can also measure the true diameter of the native vessel very accurately, since the ultrasound image penetrates plaque, critical in choosing the size stent to deploy. Stent manufacturer Boston Scientific also offers an IVUS system, but currently has no FFR capability.

Volcano Corporation, a long-time leader in these technologies, currently offers FFR, IVUS and has an OCT system on standby. However, Volcano is not a major stent manufacturer. It will be interesting to see how the advantage of the major hospital pipeline enjoyed by Medtronic will affect the FFR/IVUS field. Volcano has also been developing an alternative to FFR, called iFR, which requires no adenosine or other hyperemic agent and allows very rapid serial readings of pressures. iFR utilizes a specialized guide wire which can then be used as the guide wire for the entire stent procedure itself. ACIST's technology takes a different route: its FFR micro-catheter can be used over any standard .014" guide wire and utilizes the rapid-exchange system..

ACIST's RXi™ Rapid Exchange FFR System was approved by the FDA in January of this year.

This morning's press release from ACIST Medical Systems, Inc. follows:

ACIST Enters Co-Promotion Agreement With Medtronic To Commercialize Next Generation FFR And IVUS Technologies In U.S.
Collaboration provides increased commercial reach, brand synergies and customer access to new technologies

August 4, 2014 -- Eden Prairie, Minnesota -- ACIST Medical Systems, Inc., a Bracco Group company and global market leader of advanced contrast delivery systems for cardiology, today announced that it has entered into a strategic agreement with Medtronic, Inc. (NYSE: MDT) to co-promote the world's first Rapid Exchange FFR (RXi) and High Definition IVUS (HDi) technologies in the United States. Under this agreement, ACIST and Medtronic will work collaboratively to introduce these groundbreaking products into cardiac catheterization laboratories across the US.

FFR (Fractional Flow Reserve) has quickly become the standard that interventional cardiologists use to determine which patients can most benefit from stenting. IVUS (Intravascular Ultrasound) is an advanced diagnostic modality that provides greater insight into arterial disease than standard angiography alone. The ACIST Rapid FFR (RXi) and High Definition IVUS (HDi) systems are quicker, easier to use and offer detailed insight that physicians can use to optimize treatment choice for their patients.

"This partnership is a significant milestone in the transformation of ACIST, and will help us to achieve rapid and significant penetration of the U.S. market," said Tom Morizio, President and COO, ACIST Medical Systems. "Medtronic is a worldwide leader in delivering new and innovative medical technologies. Our products are an excellent complement to their interventional cardiology product portfolio. We see great benefits and potential in working with Medtronic to increase our share of voice and field presence through this agreement, and look forward to maximizing the awareness of these products in the U.S."

Medtronic is the global leader in Coronary Stents with an impressive interventional cardiology product portfolio into which Rapid FFR and HD IVUS fit well. Through this collaboration, ACIST and Medtronic will bring this technology to existing and new customers who value improved modalities that simplify procedures and benefit their patients.

ACIST's new Rapid FFR system, which utilizes the ultra-thin ACIST Navvus™ Rapid Exchange MicroCatheter and RXi console, was introduced earlier this year in the United States and Europe. The Navvus MicroCatheter can be used over a standard 0.014 inch guidewire, and the RXi system facilitates rapid FFR assessments before, during and post-intervention. This unique technology is the first of its kind, providing the reassurance of accurate and reliable FFR measurements and the advantages of Rapid Exchange technology.

ACIST, a Bracco Group company, is a pioneer and global market leader of advanced contrast delivery systems for cardiology. By developing advanced diagnostic technologies that help simplify the complexities of the cardiac cath lab, it empowers clinicians and their teams in providing superior patient care. ACIST products are being used by cardiologists in more than 70 countries worldwide, and more than 15 million patients have benefited from a cardiovascular angiography procedure using an ACIST Contrast Delivery System.

ACIST is headquartered in Eden Prairie, Minn., with regional offices in Europe and Asia. A team of more than 300 people worldwide helps manage and support a portfolio of products and services that simplify and enhance contrast injection procedures. ACIST and its sister company, HLT — a medical device company dedicated to the development of transcatheter aortic valve technology — are part of the Bracco Group, an international leader in diagnostic imaging. Both companies share the same founder, president and COO and commitment to innovation in interventional cardiology. Together, they are setting new standards in the industry with the pursuit of emerging cardiology solutions, addressing clinical and physician needs to provide superior patient care.

To learn more about ACIST, visit

About the Bracco Group
Bracco has headquarters in Milan, Italy, and was founded in 1927. It is active in the healthcare sector through Bracco Imaging (diagnostic imaging), Pharma (prescription and over the counter drugs), ACIST Medical Systems and HLT (cardiology) and the Centro Diagnostico Italiano diagnostic clinic. It has around 3,300 employees and annual total consolidated revenues of nearly 1.2 billion Euro. Bracco operates in more than 100 countries worldwide.

To learn more about Bracco Group, visit

About Medtronic
Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology –– alleviating pain, restoring health and extending life for millions of people around the world. In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular diseases and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

Reported by Burt Cohen, August 4, 2014