Medical Device Daily Associate Managing Editor

GE Healthcare (Waukesha, Wisconsin) and St. Jude Medical (St. Paul, Minnesota) reported that they have entered a “significant development and collaboration agreement” that is intended to bring an integrated imaging and monitoring capability to cardiac catheterization labs around the world.

The companies said they will co-develop a state-of-the-art cardiovascular ultrasound imaging system with fully integrated intracardiac echocardiography (ICE) imaging capabilities, intended for use in treating patients suffering from heart disease.

Mark Langer, the global general manager for invasive cardiology at GE Healthcare, told Medical Device Daily that the two companies have had “a rather quiet NIH-funded collaboration” to develop “some pretty innovative imaging catheter designs.”

According to Langer, the companies have finally come up with a device that they believe is best-in-class and are ready to begin the process of bringing it to market. “I guess you could say our relationship is at a place where it's becoming public.”

The device is specifically designed to treat heart rhythm disease, which affects more than 8 million people globally. It is a dysfunction in the electrical workings of a patient's heart, disturbing the heart's ability to beat normally and pump blood efficiently. The irregular electrical pulses pose significant risks such as heart muscle damage and stroke.

The most common heart rhythm disorder, atrial fibrillation (AF), is an irregular and rapid rhythm where the heart's atria quiver instead of pumping efficiently. Each year, more than 380,000 new cases of AF are diagnosed worldwide and according to Langer, there are more than 5 million people around the world who suffer from this condition.

For many AF patients, existing therapies including medications are ineffective or cause significant side effects, such as severe reduction in stamina. Ablation, in which an electrophysiologist eliminates the tissues in the heart that contribute to the disturbance of electrical flow, is an effective treatment with a success rate of 84% to 87%.

Langer noted that medication is only about 29% effective compared to the much higher success rate of ablation in the treatment of AF and wonders why ablation hasn't become the standard-of-care.

He noted that currently, because of its complexity and procedure time, ablation is performed less often than indicated, but better visualization technology is expected to make ablation procedures more accessible to patients.

“There's just a handful of physicians that can do the [AF ablation] procedure,” he said, with only about 500 around the world at this time. He said this represents a vastly under penetrated market. “There's probably only 10,000 of these AF ablations performed every year, and that's too bad because it's such an effective therapy and I think we can do things to improve it.”

Through the collaboration, GE's ultrasound technology will be integrated with St. Jude's catheter technology to provide physicians with real-time ultrasound imaging inside the heart, with direct visualization of both blood flow and other catheters used during cardiac procedures. The combined imaging technology is expected to give physicians high-quality diagnostic images of cardiac structures and blood flow throughout the entire heart, enhancing visibility and enabling more successful procedures.

“These new visualization tools are like having eyes inside the patient's heart, without actually having to open the chest,” said Laurence Epstein, MD, chief of the Cardiac Arrhythmia Service at Brigham and Women's Hospital (Boston). “The development of ICE technology has changed how we approach ablation procedures. We can visualize, in real time, the actual anatomic structures that we are targeting.”

“GE Healthcare technologies are utilized in 112 of the 120 electrophysiology teaching institutions today. This latest agreement with St. Jude Medical is a natural extension of our commitment to delivering state-of-the-art tools and technologies to the electrophysiologist,” said Laura King, global vice president, interventional, cardiology and surgery, of GE Healthcare. “We are excited about bringing together the expertise from two innovative companies to enable effective, minimally invasive therapies,” said King.

“Atrial fibrillation is one of the largest unmet clinical needs in cardiovascular medicine today,” said Dr. Peter Chen, president of St. Jude's organization that is developing the ICE catheter. “By working with GE Healthcare, we are enhancing our ongoing efforts to improve treatment options for AF patients and their physicians.”

Beyond all the terrific technology being utilized in the new system, Langer noted one other important aspect to the potential adoption of the new device once it is approved, and that is the excellent physician education programs that both companies have.

“By providing a lot more [physician] training than they've ever had before,” Langer said, “we think we can improve [ICE] use and adoption.”

In other agreements news:

• Athersys (Cleveland) reported that the Addvance division of Angiotech Pharmaceuticals (Vancouver, British Columbia) has made an investment in the company to support the development of cell-based products for treating cardiovascular disease.

The initial work will focus on applying Athersys' proprietary adult-derived stem cell product, MultiStem, to treat patients who suffer a heart attack.

“We believe that MultiStem has the potential to significantly enhance the treatment of cardiovascular disease, and, through this partnership with Angiotech, we look forward to exploring a variety of clinical indications in the cardiovascular area, such as peripheral vascular disease and chronic ischemia,” said William Lehmann, executive vice president, corporate development and finance for Athersys.

The companies will jointly manage development activities, and will share clinical development costs. In addition, upon the achievement of certain development and commercialization milestones, Athersys will be eligible to receive milestone payments, and the companies will share profits on all developed products. After completing pre-clinical studies, it is anticipated that human clinical trials applying MultiStem toward the treatment of myocardial infarction could begin in 2007.

MultiStem is a patented stem cell product that is based on a special class of adult-derived stem cells known as Multi-Potent Adult Progenitor Cells.

• Affiliated Computer Services (Dallas), a provider of business process outsourcing and information technology solutions, and dbMotion (Atlanta/Ra'anana, Israel), a provider of web-based data-sharing technology that helps facilitate regional health information organizations and health information exchanges, reported that they have strategically partnered to deliver a medical information sharing solution for the global healthcare market.

The joint solution will enable healthcare organizations worldwide to quickly and cost-effectively meet their specific service and technology requirements for medical information sharing networks.

The ACS/dbMotion partnership is expected to help further expand ACS' breadth of capabilities and offerings for the healthcare market by adding a technology solution specifically designed for medical information sharing. At the same time, the collaboration will enable dbMotion to increase its market penetration by linking with an industry-leader in healthcare solutions. Both companies anticipate that the synergy of their offerings will create an industry standard for medical information sharing that can be used around the globe.