Sorin Group (Milan, Italy) reported receiving CE marking for its new Cobalt Chrome coronary carbostent, the Chrono stent. The company said that Chrono will be “fully released” in Europe and all the CE mark countries. Sorin said that since its recent introduction as a new material for coronary stents, Cobalt Chrome has demonstrated “excellent characteristics including higher mechanical strength and radiopacity than stainless steel.” It said that its advantages are enhanced by a stent design engineered to provide more flexibility and a new delivery system, PTS (Progressive Transition System), which ensures reliable access to distal and tortuous anatomies.

The stent also features two radiopaque markers at each end of the stent to guarantee accurate placement at the target lesion. Chrono is coated with Carbofilm, a Sorin proprietary coating that has demonstrated improved hemo- and bio-compatibility of the stent and to reduce stent thrombosis in a number of registries and randomized trials. Chrono features extremely thin struts and the lowest crossing profile, providing flexibility without compromising radial strength and a new tapered tip giving excellent crossability.

The company said that the first implants in Europe have demonstrated the benefits of Chrono in the treatment of complex and distal anatomies. Chrono “has shown excellent procedural performance even in complex and challenging lesions, where deliverability is a main issue,” said Professor Bartorelli of Monzino Centro Cardiologico (Milan).

AGA to study PFO/migraine link in Europe

AGA Medical (Golden Valley, Minnesota) reported that it has received approval from the Cantonal Ethical committee in Bern, Switzerland, to initiate enrollment in a new study examining the connections between migraine headaches and patent foramen ovale (PFO), a heart defect found in more than 20% of all adults. The company also recently reported FDA approval for a similar trial in the U.S.

The device is implanted via a catheter inserted in the patient’s groin. The procedure typically takes from one hour to as little as 15 minutes among experienced physicians, and the patient is able to go home in less than 24 hours, according to the company.

The PRIMA (Patent foramen ovale closure Reduction In Migraine with Aura) trial is a prospective, randomized, two-arm, multicenter trial to determine whether patients who undergo closure of a PFO with the company’s Amplatzer device have a reduction in both the number and severity of migraine headaches. The study is expected to enroll about 120 patients at up to eight medical centers in Europe.

“The causes of migraine are still not clearly understood. If the results of the trial are positive, PFO closure may prove to be the first treatment that eliminates the cause of one form of migraine, instead of treating only the symptoms,” said Dr. Heinrich Mattle, co-director of the Department of Neurology, University Hospital (Bern) and principal neurology investigator. “In addition to potentially resolving a major health concern in a specific group of patients, we may learn important factors in the origins of migraine that could advance treatment in other areas as well.”

AGA said that recent studies indicate that a significant number of patients experience a reduction in the frequency and severity of migraine headaches following closure of a PFO. The Amplatzer PFO Occluder offers a less-invasive alternative to open-heart surgery for closing a PFO. The randomized trial is designed for comparative evaluation of the effectiveness of PFO closure in migraine reduction.

Transplant monitoring study at ISHLT

A recent study shows promise for cardiac transplant patient monitoring with new noninvasive procedures to help predict organ rejection. Mandeep Mehra, MD, head of the Division of Cardiology at the University of Maryland School of Medicine (Baltimore), presented the study in Madrid at the 26th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation.

The study was sponsored by XDx (South San Francisco), whose laboratory provides the gene expression testing service, the AlloMap test, used in this investigation. Data from the study show that a gene expression pattern in heart transplant patients, initially validated to detect the absence of ongoing acute cellular rejection, can anticipate acute cellular rejection.

The study examined the messenger RNA gene expression patterns of 104 heart transplant recipients at least one-month post transplant who showed no signs of current rejection on biopsy. Of the sample, 39 patients developed acute cellular rejection within 12 weeks, and on average, higher gene test scores were noted for those future rejectors, compared to those who remained rejection-free.

The genes actively predictive of rejection were those modified by corticosteroids, a backbone of immunosuppressive drug therapy in transplantation. Similarly, following treatment of rejection, the gene expression patterns showed improvement toward the baseline. These findings were examined further in a series of 192 representative patients, demonstrating a negative predictive value of 98.9% for a gene expression score that indicated quiescence.