A Medical Device Daily

ORLANDO, Florida – Companies continued to roll out a large array of new products at the American College of Cardiology's (ACC; Bethesda, Maryland) annual meeting being held here this week.

Evalve (Redwood City, California) reported that when leaky mitral valves in patients' hearts were repaired non-surgically with a tiny, catheter-fed clip developed by the company, nearly all – more than 90% – of the patients whose mitral regurgitation (MR) was significantly reduced one month after receiving the clip maintained the reduction at six months. In addition, 75% of the patients who received the clip as part of a Phase I clinical trial are still surgery-free.

Mitral regurgitation is a debilitating condition that occurs when the mitral valve, which allows blood to move through the heart, fails to close properly.

"As we get more experience with this procedure, we're seeing that our ability to control the MR is increasing and the time it takes to accomplish the repair is decreasing. With this device, we can provide a minimally invasive option for decreasing valve leakage without taking away the patient's ability to have surgical valve repair in the future, if it's needed," said principal investigator Ted Feldman, MD, director of the cardiac catheterization lab at Evanston Hospital (Evanston, Illinois), flagship of the Evanston Northwestern Healthcare system.

Results of the study, known as the Endovascular Valve Edge-to-Edge Repair Study (EVEREST I) trial, which used the company's MitraClip, were part of the Oral Contributions: Percutaneous Valve Procedures Session. It is titled "Percutaneous Edge-to-Edge Mitral Valve Repair Using the Evalve Clip: Update on the EVEREST Phase I Clinical Trial."

To date, a total of 27 patients with severe mitral regurgitation have been enrolled in the trial. Feldman performed the first U.S. procedure in Evanston Hospital's cardiac cath lab.

"As a group, we have seen minimal rates of complications occur during the procedures," said Feldman. "We've also seen that for the majority of patients who achieve good initial results, favorable results are sustained. The patients who did not receive optimal MR control with the clip were able to have routine, conventional mitral valve surgery," he added.

Nationwide, study centers will soon begin enrolling eligible patients in EVEREST II, a prospective, randomized, multi-center study that will compare the clip approach with open-heart valve surgery.

Also at ACC:

IDX Systems (South Burlington, Vermont), a provider of healthcare information systems, reported the launch of IDX Imagecast for Cardiology.

Imagecast for Cardiology provides comprehensive workflow management focused on improving access, procedural throughput and closed loop reporting. The system is designed to allow users throughout the healthcare enterprise and beyond to access and share information and images when and where they need them. Imagecast also allows specialty and sub-specialty providers such as cardiologists to automate their workflow based on their unique interpretation and reporting needs, while providing complete diagnostic image access from a PC.

The product includes a continuously available cardiovascular information system and a cardiovascular picture archiving and communications system. Built on the same database as Imagecast for Radiology, Imagecast for Cardiology leverages a hospital's investment in Imagecast technology.

Newly analyzed research on Orqis Medical's (Lake Forest, California) Cancion Cardiac Recovery System (CRS) for treating congestive heart failure will be presented at the meeting, the company said.

The data suggests that patients with acutely decompensated chronic heart failure may benefit from Cancion therapy. Based on Orqis Medical's discoveries in hemodynamic principles, the therapy is designed to create a unique "rest to recovery" environment that enables the failing heart to rest as it continues to function.

The company said it represents a "significant departure" from conventional drug therapy and more invasive blood pumps, which either force the failing heart to work harder, or rest it to the point where it begins to atrophy.

"The patients we analyzed clearly benefited from the Cancion CRS therapy," said Michael Zile, MD, professor of medicine at Medical University of South Carolina (Charleston, South Carolina), who analyzed the research data. "By providing continuous aortic flow augmentation, the therapy enabled patients to experience progressive improvement in key measures such as cardiac index and pulmonary capillary wedge pressure."

Zile's oral presentation, titled "Continuous Aortic Flow Augmentation Using Orqis Cancion Cardiac Recovery System in Patients with Severe Heart Failure: Determinants of the Hemodynamic Response," will be delivered this morning.

The presentation includes data from 24 patients with congestive heart failure who participated in Orqis Medical's feasibility trials in the U.S. and Europe.

The Cancion CRS is the first therapy for congestive heart failure that supplements blood flow specifically in the descending aorta with the aim of initiating progressive hemodynamic improvement.

Ongoing research is focused on the therapy's ability to induce vasodilation and improve renal blood flow while reversing the body's compensatory effects caused by abnormal aortic flow.

To meet the demands of the U.S. cardiology market, Toshiba America Medical Systems (TAMS; Tustin, California) said it is introducing a new optimized cardiac configuration for the Excelart Vantage, the company's 1.5 Tesla (1.5T) high-field MRI system equipped with one of the shortest magnets in the industry.

Based on the Vantage XGV platform, the new Vantage CGV configuration features gradient strength of 30 mT/m (milliTesla per meter) and a slew rate of 130 mT/m/ms (milliTesla per meter per millisecond) to meet clinical requirements for advanced cardiac MRI examinations.

"With the introduction of the new cardiac configuration for the Vantage lineup, Toshiba is further expanding our presence in the 1.5T high-field MRI category with a dedicated system designed to meet the clinical demands of the expanding cardiology market," said Bob Giegerich, of TAMS' MRI Business Unit. "In addition to a list of exclusive patient-focused features of the Vantage, the new Vantage CGV adds advances, such as a specialized cardiac coil, and application packages for high-resolution cardiac imaging and quantification analysis."

TAMS makes diagnostic imaging systems and coordinates clinical diagnostic imaging research for all modalities in the U.S.