AGA Medical (Golden Valley, Minnesota) reported enrollment of the first patients in its newest clinical trial – PRIMA (Patent foramen ovale closure Reduction In Migraine with Aura) – intended to examine the connections between certain types of migraine headaches and a heart defect found in more than 20% of all adults. The first patients were enrolled at the Swiss Cardiovascular Center Bern, University Hospital (Bern, Switzerland).
PRIMA is a prospective, randomized, two-arm, multicenter trial to determine whether patients who undergo closure of a PFO with the company’s Amplatzer PFO Occluder device have a reduction in both the number and severity of certain types of migraine headaches. The study is expected to enroll about 120 patients at up to 10 medical centers in Europe.
Heinrich Mattle, MD, deputy chairman of the department of neurology of the university hospital in Bern and principal neurologist investigator for PRIMA, said that the trial “is designed differently than the previous PFO Migraine trials in that the endpoint is a more appropriate 50% reduction of migraines in 50% of the patients. Additionally, the roll-in phase is longer, the follow-up treatment phase is longer, and neurologists are important investigators in the trial.”
About 11% of the population suffers from migraine headaches, and observational studies have reported a significant number of patients experience a reduction in the frequency and severity of migraine headaches following closure of a PFO.
Trial neurology and cardiology specialists will select migraine patients with aura, a headache with pain that is accompanied by flashing lights, vision loss, and other temporary neurological deficits. They will provide randomized treatment of either PFO closure with the Amplatzer PFO Occluder, or medical treatment. This randomized trial is designed for comparative evaluation of the effectiveness of PFO closure in migraine reduction.
The Amplatzer PFO is implanted via a catheter inserted in the patient’s groin. The procedure typically takes as little as 15 minutes by experienced physicians, and the patient is back to normal lifestyle in less than 24 hours.
PRIMA is one of two AGA Medical-sponsored studies exploring the link between PFO holes and certain types of migraine headaches. The other study is taking place in the U.S.
First implants of ZoMaxx DES initiate trial
The first patients have been enrolled in Abbott Laboratories’ (Abbott Park, Illinois) ZoMaxx Europe clinical trial. All were treated with the ZoMaxx drug-eluting coronary stent system for their coronary artery disease.
Karl Hauptmann, MD, head of internal medicine in the department of cardiology at Hospital of the Merciful Brother (Trier, Germany), performed the first procedures.
The ZoMaxx system features application of a biologically inert coating called Pharmacoat (phosphorylcholine, or PC), intended to enable steady drug elution over time, and application of Abbott’s immunosuppressant drug, zotarolimus, which has been studied for the reduction of vessel re-narrowing.
Phosphorylcholine is licensed to Abbott from Biocompatibles International (Singapore).
Abbott describes zotarolimus as “the only drug designed exclusively for use on drug-eluting stents.”
The system’s TriMaxx stent platform is made of stainless steel and tantalum, which the company said is “designed to enable optimal visibility under X-ray, with extremely thin struts and an ultra-low crossing profile to facilitate ease of stent placement.”
The ZoMaxx Europe study is a single-arm trial that will evaluate the safety and performance of the ZoMaxx zotarolimus-eluting stent in patients with single- or two-vessel coronary artery disease.
Abbott said the trial, which will include about 900 patients at up to 60 sites throughout Europe, represents an “important step” toward broadening the complexity of patients treated with the ZoMaxx stent.
The primary endpoint of the trial is target lesion revascularization (TLR) at nine months.
Franz-Josef Neumann, MD, of Herz-Zentrum Bad Krozingen Hospital (Baden-Wurttemberg, Germany), principal investigator of ZoMaxx Europe, said, “Abbott’s drug-eluting stent has unique characteristics, and we look forward to studying the ZoMaxx system in patients with coronary artery disease, including those suffering from multi-vessel disease.”
Abbott plans to seek approval to market ZoMaxx in Europe later this year.
CardioTech trial plan okayed
CardioTech International (Wilmington, Massachusetts) said it has received written acknowledgement from its Notified Body in Europe that its clinical trial plan for CardioPass synthetic coronary artery bypass (SynCAB) has been accepted.
Following the 10-patient trial, the analyzed data will be submitted by CardioTech to the Notified Body in support of the company’s CE mark application.
The trial protocol allows surgeons to intraoperatively decide to use CardioPass synthetic coronary artery bypass instead of autologous vessels. Patients will be followed for 90 days and assessed for graft patency and quality of life measures.
Michael Szycher, PhD, chairman and CEO, said, “This planned trial brings us a step closer to fulfilling the unmet need of providing patients with a suitable alternative to an autologous vessel.”
CardioTech estimates that of the 600,000 coronary bypass operations performed worldwide, about 15% of veins are found to be suboptimal.
Michael Adams, vice president of regulatory affairs and business development, said, “Potential clinical trial sites have been identified and we will be working closely with them as we prepare to commence the study.”
Heart Laser system gets Japan approval
PLC Systems (Franklin, Massachusetts) said that Ktec (Tokyo), its exclusive distributor in Japan, has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market PLC Systems’ first-generation CO2 TMR Heart Laser System (HL1) in Japan.
CO2 TMR offers a treatment option for angina patients who suffer from severe coronary artery disease. PLC developed the CO2 Heart Laser, the world’s first transmyocardial revascularization (TMR) angina relief device approved by both the Japanese MHLW and the FDA.
Mark Tauscher, president and CEO of PLC Systems, said, “We believe the Japan Ministry of Health approval reinforces the strength of the scientific data and clinical evidence that supports the use of CO2 TMR by cardiac surgeons for very sick heart patients.”
He added, “TMR fits very well within the portfolio of tools and technologies that surgeons have to treat the expanding population of heart patients who have limited choices available for revascularization therapies.”
PLC said that to date, Ktec (formerly known as Imatron Japan), has made investments in purchasing its heart lasers, funding a clinical trial in Japan and supporting the regulatory approval process in that country.
Going forward, Ktec will manage the ongoing regulatory, clinical, marketing and sales activity for CO2 TMR in Japan. For the remainder of 2006, Ktec will begin the process of establishing the TMR market through hosting educational seminars, attending scientific trade shows and conducting training events.
Currently, Ktec has 12 HL1s in Japan.
Expanded indications OK’d for Taxus Libert
Boston Scientific (Natick, Massachusetts) said it has received indication extensions to the European CE mark for its Taxus Libert paclitaxel-eluting coronary stent system for use in what it characterized as “some of the most challenging coronary procedures.”
The new labeling reflects a review of Taxus clinical data by the European regulatory agency. In addition to its existing indication for the treatment of de novo lesions in native coronary arteries, the Taxus Libert system is now indicated in Europe for the treatment of restenotic lesions (in-stent restenosis, or ISR) and total occlusions (TO) in patients with coronary artery disease, including acute myocardial infarction (AMI). These three new indications account for more than 20% of all coronary interventions.
Boston Sci said the Taxus Libert stent system is now the only drug-eluting stent system with these new indications for use in Europe.
This revised labeling follows what Boston Scientific called “the excellent clinical outcomes the Taxus stent system has shown in the treatment of complex lesions in recent clinical trials and registries, including the TAXUS V ISR trial and the MILESTONE II, WISDOM, ARRIVE, and OLYMPIA registries.”
In addition to the three new indications, the large-vessel diameter Taxus Libert stent also received the CE mark. The company said this stent uses a modified cell design intended for drug delivery in larger vessels, and will be available in a 4 mm diameter and seven different lengths.
“The European approval for new indications recognizes the strong long-term performance of the Taxus stent system across complex patients and lesions,” said Jeff Goodman, president of Boston Scientific International.
CoreValve begins trial with 3rd-generation system
CoreValve (Irvine, California/Paris) said last month that it has initiated the feasibility phase of a clinical trial using its third-generation 18 Fr ReValving system. The “Generation-3” trial, which has commenced ahead of schedule, is expected to enroll up to 100 patients at 12 sites in Europe and Canada.
The first procedure was performed in the cath lab at the Heart Center Siegburg (Siegburg, Germany).
The company’s third-generation system, consisting of an 18 Fr-sized delivery catheter, was used to percutaneously implant CoreValve’s porcine pericardial-tissue bioprosthesis over the severely calcified aortic heart valve of a 91-year-old female patient, who was discharged from the hospital’s ICU on the morning after her ReValving procedure.
CoreValve said that to date, all of the 44 ReValving patients who have been discharged from the hospital “continue to demonstrate improved cardiac function, zero long-term complications and dramatically enhanced quality of life at follow-up out to 17 months,” with a mean follow-up of 9.5 months.
It said that, left untreated, “up to 25% of these high-risk and inoperable patients would have faced certain death within 12 months.” Jacques S guin, MD, PhD, chairman, CEO and founder of CoreValve, said the ReValving system has “extraordinary possibilities for interventionally treating the thousands of patients who have defective aortic heart valves but who are contraindicated for open-heart surgery.”
Noting that the company’s first generation of percutaneous aortic valve replacement catheters was 25 Fr, “which is a very sizeable catheter by interventional standards,” he cited the reduction in size to 18 Fr, terming that “a rather extraordinary technical achievement in the less than two years since our ‘first-in-man’ procedure.”
The reduction in size offers “significant procedural benefits for the interventional cardiologist and his patient,” S guin said.
Rob Michiels, president and chief operating officer, said, “This rapid technological progress is the result of a strategy that focused on a new design for a bioprosthesis specifically for percutaneous application. We believe we are on schedule to secure a CE mark and first-to-market position for our ReValving system in Europe next year.”
Exponent carotid stent approved
Medtronic (Minneapolis) said in late April that it had received CE-mark approval for its next-generation self-expanding carotid stent and filter system, providing patients afflicted by carotid artery disease with a new, minimally invasive treatment option to surgical procedures for the prevention of stroke.
The new Medtronic Exponent RX Self-Expanding Carotid Stent is used to prop open a blocked artery and restore adequate blood flow. It is part of the Medtronic Carotid Solution, which also includes the Interceptor PLUS Carotid Filter System. This filter is a miniature mesh basket that allows blood to flow normally while it traps loose particles in the bloodstream and prevents them from reaching the brain and causing a stroke during the procedure. The Medtronic Carotid Solution also includes additional products that provide alternative methods of removing embolic debris from the bloodstream.
The first procedures using the new stent and filter occurred at hospitals in Italy. The procedures were performed by Alberto Cremonesi, MD, and Fausto Castriota, MD, both of the interventional cardio-angiology unit at Villa Maria Cecilia Hospital (Cotignola, Italy), and by Carlo Setacci, professor of vascular surgery and chief of the department of general and specialistic surgery at University Hospital Santa Maria alle Scotte (Siena, Italy).