CARDIONEXUS GETS A PUSH FROM PANASONIC, FDA NOD FOR DEVICE

 

By JIM STOMMEN Medical Device Daily Contributing Writer


A young Texas company that is the result of a unique partnership involving a gigantic global maker of consumer electronics has received FDA approval to sell its ultrasound-based system for the early detection of heart disease, with sales having begun immediately upon receipt of the agency's go-ahead last week.

The CardioHealth Station from CardioNexus (Houston) uses a portable ultrasound system to perform non-invasive heart examinations in the field. The system can detect arterial plaque and measure the thickness of arterial walls.

CardioNexus is a joint venture between Panasonic Corp. of North America (Secaucus, New Jersey) and Fairway Medical Technologies (also Houston), whose focus is commercialization of early-stage medical devices and technologies. CardioNexus was founded in January 2009 to focus on early detection of cardiovascular disease.

Morteza Naghavi, MD, president/CEO of both Fairway and CardioNexus, told Medical Device Daily on Monday that use of the device has been a "jaw-dropping" experience for physicians who have used the CardioHealth Station during clinical trials. "Opinion leaders in the field have been outspoken in their positive responses to the device," he said.

Naghavi said the CardioHealth Station "looks like a big iPod," and cited its ease of use: "You just put the device on a patient's neck and the machine guides you; you don't even need to push a button to proceed with the exam."

He said the device is intended for diagnostic use in physicians' office settings – particularly those of primary care physicians, internists and family physicians, whom Naghavi said are "absolutely our main target. They're the ones who are underserved – they simply don't have these kinds of devices in their offices."

Naghavi, who is internationally recognized as a leader in heart attack prevention initiatives, is a serial entrepreneur who has founded four medical companies, including Volcano (San Diego, California), a firm focused on detection of vulnerable plaque, which went public in 2006. Volcano was based on work done by Naghavi and colleagues at the Texas Heart Institute (Houston).

CardioNexus says that traditional risk factors such as cholesterol, blood pressure, etc., are not enough and often misclassify patients. And traditional ultrasound measurement of carotid wall thickness (CIMT) is dependent on having a skilled operator to perform the studies and "is a multi-step process that is time-consuming to perform," says the company.

Naghavi said that about two years ago, Panasonic decided to enter the healthcare arena full speed. "They're the world's largest electronics manufacturer, with some 380,000 employees worldwide," he said, adding that the company "has a ton of technology" and is listed as holding the largest number of patents of any company worldwide.

"But their decision to get into healthcare came kind of late in the game, so they elected to focus on 'early healthcare,' or preventive types of medicine, as well as home health," he said, segments where there isn't as much competition as more traditional market sectors.

"They're really aiming at the personalized medicine space," Naghavi added.

The electronics giant "needed partners, so they came to us at Fairway because they saw my background as a preventive cardiologist to be a good fit and we started a relationship," he said. With Fairway and Naghavi's track record in early detection and treatment for cardiovascular disease, that relationship soon blossomed into the entity known as CardioNexus.

Simply put, the relationship is broken down into Panasonic doing all the manufacturing while CardioNexus does all the clinical development and product positioning. The initial U.S. marketing efforts will be directed by CardioNexus, "but we'll look to Panasonic when we're ready to move globally," he said.

As for the science behind the CardioHealth Station, Naghavi noted that the early detection of cardiovascular disease "has been an interest of cardiologists for years, but until recently the main focus has been on CV risk factors such as family history, cholesterol, blood pressure and the like.

"But risk assessment has many limitations," he said, "and the fact is that the majority of people who come in with heart attack symptoms don't fit the traditional risk profile." So organizations such as the American College of Cardiology (ACC; Washington) and American Heart Association (Dallas) have recommended direct assessment of risk via methods such as measuring coronary calcium and the thickness of vessel walls, "but those assessments typically aren't available in many physicians' offices," Naghavi said.

"The obvious solution," he said, "is ultrasound, but the problem with traditional ultrasound is that you need a savvy operator, more costly high-resolution machines, and more of a patient's time."

Enter CardioHealth Station, a device that Naghavi said had its genesis in work begun 5-1/2 years ago. He said the device is "newly designed, built from the ground up. "It's a huge advantage for doctors such as primary care physicians, internists and family physicians – it's a very revolutionary piece of equipment noteworthy for its ease of use. You don't even need to hit buttons; just place the equipment at the patient's neck and the machine guides you." And it only takes about five minutes to carry out the test.

The physicians who have seen the equipment to date say "this is mind-blowing, it's exactly what we have needed," Naghavi said. "It's very revolutionary."

He said he expects the CardioNexus/Panasonic booth at the upcoming ACC meeting in New Orleans next week to pretty much be swarmed with physicians drawn to the new technology. Naghavi said the companies will be exhibiting at 20-some medical meetings over the next several months as they roll out the CardioHealth Station.

And more indications are in the pipeline beyond risk factor profiles and IMT/plaque. Some of the others that CardioNexus indicates as areas of interest include point-of-care blood testing, blood pressure and ankle brachial index checks, and body measurements such as height, weight and body mass index.

 

 

 

SOURCE:  http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=74969




About CardioNexus Corporation
CardioNexus Corporation is an affiliated company of Panasonic Healthcare dedicated to reducing cardiovascular disease through early detection and prevention. CardioNexus’ flagship product, the CardioHealth® Station, is a new multi-modality initiative to advance cardiovascular health assessment for the prevention of heart attack and stroke. The advanced, automated features of the CardioHealth® Station enable physicians, especially primary care physicians and internists, to perform atherosclerosis imaging and cardiovascular risk assessment in their offices, without need for outside referral.

About Panasonic
Based in Secaucus, NJ, Panasonic Corporation of North America provides a broad line of digital and other electronics products for consumer, business and industrial use. The company is the principal North American subsidiary of Panasonic Corporation (NYSE: PC), and the hub of Panasonic’s U.S. branding, marketing, sales, service and R&D operations. Panasonic Corporation of North America’s newly formed Healthcare Group brings together Panasonic’s expertise in a wide range of health and medical device technologies, including hearing care. For more information visit www.panasonic.com/hearing  Additional Panasonic information for journalists is available at www.panasonic.com/pressroom

About Panasonic Healthcare Co., Ltd.
Panasonic Healthcare Co., Ltd., headquartered in Matsuyama, Japan, is an internal division company of Panasonic Corporation (NYSE: PC) that specializes in the development and manufacture of healthcare products, including blood glucose monitoring systems, ultrasound diagnostic systems and hearing instruments. Founded in 1948, the company has been developing cutting-edge technologies in in-vitro diagnostic systems, medical imaging, hearing solutions, medical instruments and hospital systems to provide value-added solutions to healthcare professionals and patients. The previous corporate name was Panasonic Shikoku Electronics Co., Ltd., which was changed to the current Panasonic Healthcare Co., Ltd. on October 1, 2010.

 

 

 

 

 

 

 

 

 

 

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