Roche Diagnostics (Indianapolis) has received FDA clearance for what the company says is the first and only natriuretic peptide test to be green-lighted by the FDA for risk assessment of cardiac events in people with stable coronary artery disease. The company said that nearly 13 million people in the U.S. have stable coronary artery disease, making them more susceptible than the general population for the development of adverse cardiac events. The test is designed to run on Roche’s Elecsys systems and Modular Analytics E170 immunoassay analyzers.

“This additional application for use of NT-proBNP provides significant opportunities to help patients and their physicians learn more about their cardiac status and their cardiac risk,” said Mike Samoszuk, MD, chief medical officer of Roche Diagnostics, in a prepared statement. “Millions of people in the U.S. have a high risk of developing cardiac events, because they have stable coronary artery disease.

He added: “Since this is an early marker of cardiac involvement in these disease processes, once a person is identified to be at cardiac risk, they can work with their physician to determine the best treatment and therapy early on. Laboratory tests like this are changing the way physicians approach patient care.”

In an e-mail to Cardiovascular Device Update, a spokeswoman for Roche wrote that the FDA clearance was granted based on “three large studies with a total of 2,997 subjects.” Researchers measured proBNP levels and followed patients for a mean follow-up of five years. “After adjusting for other co-variables (age, gender, body mass index, lipids, etc.), Elecsys NT-proBNP remained a strong independent predictor of cardiovascular morbidity and mortality,” she wrote, including angina, heart attack and heart failure.

Roche’s proBNP test also is cleared as an aid in the diagnosis of individuals suspected of having congestive heart failure and as a marker of risk for patients with acute coronary syndrome and congestive heart failure, the company said.

Elsewhere in the product pipeline:

• Acusphere (Watertown, Massachusetts) said that the Journal of Controlled Release recently published a research paper describing the company's porous microparticle technology and AI-700, an ultrasound contrast agent for use in echocardiography. AI-700 is Acusphere's lead product candidate and is currently in Phase III clinical trials. The cardiovascular drug is intended to improve the use of ultrasound in effectively screening patients for coronary heart disease (CHD) by enabling clinicians to obtain information regarding myocardial perfusion with ultrasound, which the company said has potentially significant cost and convenience advantages over nuclear stress tests. In Phase II clinical trials, ultrasound using AI-700 demonstrated greater than 30% higher sensitivity than ultrasound without AI-700 and equal sensitivity in detecting CHD to nuclear stress tests.

• Angiotech Pharmaceuticals (Vancouver, British Columbia) said that its Vascular Wrap Paclitaxel-Eluting Mesh/Lifespan Vascular Graft has received a designation of “device” from the FDA’s Office of Combination Products. The company said the device designation has historically indicated a faster regulatory and commercial timeline for a product as compared to when the FDA considers a combination product to be a drug. Angiotech said it plans to initiate the PREVAIL (Paclitaxel Releasing Extra-Vascular Anastomosis Implant & Lifespan Graft) clinical trial in the first half of 2006. PREVAIL will be designed to assess the efficacy and safety of Angiotech’s Vascular Wrap paclitaxel-eluting mesh/Lifespan vascular graft combination product in patients with end-stage renal disease who are undergoing hemodialysis. As a combination product, the graft serves as an access port for hemodialysis and the intent of the drug-eluting mesh is to prevent the scar formation that often leads to graft failure.

• Biophan Technologies (Rochester, New York), a developer of next-generation medical technology, reported that one U.S. patent has issued to the company, and one U.S. patent has issued to one of its licensors who has granted Biophan exclusive worldwide medical rights. U.S. patent No. 6,980,848 “Optical MRI Catheter System,” teaches the application of photonic technology in combination with miniature MRI receiver coils incorporated into diagnostic catheters, eliminating unwanted heating associated with electrical conductors. U.S. patent No. 6,980,865, “Implantable Shielded Medical Device,” licensed to Biophan by Nanoset (East Rochester, New York), discloses a flexible and biocompatible shielding assembly for electrical conductors used with implantable medical devices. This patent covers use of nanomagnetic and carbon-based structures providing a range of electromagnetic shielding for internal electrical conductors, as well as a high degree of thermal isolation for tissues external to the shield.

• Biosite (San Diego) reported submitting a 510(k) premarket notification with the FDA for diagnostic tests for myeloperoxidase (MPO), a biomarker of inflammation in the walls of coronary arteries. Biosite said it plans to offer a single Triage MPO Test and a second generation Triage Cardio ProfilER Panel that will include MPO. The company said it believes the addition of MPO to the Triage Cardio ProfilER Panel can advance the diagnostic and prognostic utility of the product, used for emergency assessment of chest pain patients. The panel currently measures the levels of troponin and its complexes, along with CK-MB, BNP and myoglobin in blood and is used as an aid in the diagnosis of myocardial infarction, diagnosis and assessment of severity of congestive heart failure and risk stratification of patients with acute coronary syndromes.

• Cardiogenesis (Foothill Ranch, California), a manufacturer of surgical products and accessories used in angina-relieving transmyocardial revascularization and percutaneous myocardial channeling (PMC) procedures, reported it has received FDA approval, under an investigational device exemption, on the clinical trial protocol for the PMC procedure. Prior to receiving the protocol approval, the company entered into a binding letter of agreement with the FDA to ensure that key scientific and clinical issues regarding the PMC technology and trial are clearly understood and agreed to prior to commencing the study. Following receipt of the protocol approval, the company said it plans to continue its search for a strategic partner and begin the U.S. trial this year.

• CoreValve (Paris) reported that follow-up testing conducted several days after the first percutaneous ReValving procedure performed in North America to replace a patient’s defective aortic heart valve showed perfect functioning and anchoring of the new biological heart valve. Because of a ReValving procedure performed at Montreal Heart Institute, the 64-year-old high-surgical-risk female patient was able to avoid open-heart surgery. CoreValve has developed a system for replacing an aortic heart valve via a percutaneous approach on a beating heart. Excluding prep time, the second-generation CoreValve Percutaneous ReValving System holds, delivers and places a porcine pericardial-tissue bioprosthesis, via a small, 21 Fr-sized catheter, during a 15-minute procedure performed by an interventional cardiologist in a cath lab setting.

• CryoCath Technologies (Montreal) reported that Dr. Douglas Packer from the Mayo Clinic (Rochester, Minnesota) presented additional data from the feasibility stage of the Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF) investigational device exemption study using the company's Arctic Front catheter to treat atrial fibrillation (AF). The data were presented at the International Boston Atrial Fibrillation Symposium. Packer reported data on two sets of Arctic Front patient data. He reviewed the 12-month data from the original 20 patient European trial which saw 84% of patients AF-free (a further 10% had significant reductions in AF burden and have conditions that do not warrant re-treatment and are considered clinically successful). Secondly, he reported on early data from 15 patients treated in the feasibility stage of the STOP AF trial who have now reached a minimum three-month follow up point. Thirteen patients are now AF-free (87%), one has been retreated, and one other scheduled to be retreated (one retreatment is consistent with the study's protocol). There were no reported permanent serious device-related adverse events.

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