Bristol-Myers Squibb Medical Imaging (North Billerica, Massachusetts) and Thermocore Medical Ltd. (Guildford, UK) reported in late November that they have entered into a global development and commercialization agreement for Thermocore's intracoronary thermographic catheter system and related platform technology.

Financial terms of the agreement were not disclosed.

Under the agreement, Bristol-Myers Squibb Med- ical Imaging has acquired the worldwide rights to develop and manufacture Thermocore's proprietary platform technology and its intracoronary thermographic catheter system, which is designed to detect vulnerable plaque by mapping temperature variations inside the coronary arteries.

John Yianni, PhD, Thermocore's CEO, hailed the agreement, saying: "Vulnerable plaque is now recognized as the major precipitating cause of heart attack and we believe that our unique technology platform has the potential to play an important role in the diagnosis and management of this disease."

Cory Zwerling, president of Bristol-Myers Squibb Medical Imaging, said the agreement "reinforces our commitment to advance the field of cardiovascular imaging through innovative products and technologies." He added that Thermocore's technology platform "could represent an important advance in the identification and characterization of vulnerable plaque in the coronary arteries" and said, "we are looking forward to further defining the potential of this promising technology in hopes of facilitating earlier intervention and improved outcomes for patients at risk."

Research that has been conducted in recent years has indicated that the development and rupture of vulnerable or unstable plaque in the coronary arteries is a prime cause of heart attack and sudden cardiac death (SCD). Comprised of deposits of fat, calcium and other substances in the inner lining of the arteries, vulnerable plaque also contains inflammatory cells that may be associated with local increases in temperature relative to normal areas of the vessel wall. When such plaque ruptures, it can trigger the formation of blood clots that can obstruct blood flow to the heart muscle and lead to a heart attack or SCD.

Incorporating a series of sensitive temperature sensors into the distal end of the catheter system, Thermocore's temperature catheter system provides a thermal imaging map of the interior of the coronary arteries. Mapping of such temperature differentials could potentially help identify and localize vulnerable plaque before it ruptures and creates clots.

Bristol-Myers Squibb Medical Imaging said clinical trials of the device initially would be aimed at defining the prognostic clinical value of identifying plaque with an elevated temperature. Subsequent studies will be directed toward assessing whether intervention based upon such identification of vulnerable plaque has a favorable effect on clinical outcomes.

'High-risk' categories reimbursed

Boston Scientific (Natick, Massachusetts) said in late-November that the French government has added new categories of "high-risk" patients to the reimbursement approval criteria for the company's Taxus Express2 paclitaxel-eluting coronary stent system.

Under the French reimbursement system, patients are defined as high-risk if they have an increased chance of experiencing restenosis, or re-blocking of the artery after angioplasty and stenting. Published Nov. 17 in the Journal Officiel de la Republique Francaise, the official journal of the French government, the change officially will take effect in private hospitals and clinics 13 days following publication.

Reimbursement for the Taxus Express2 originally was approved in France only for diabetic patients and for those whose lesions were located in small vessels those with a vessel diameter of less than 3 mm.

The new high-risk categories provide reimbursement for long lesions (greater than 15 mm in length) and lesions located in the proximal left anterior descending artery. Reimbursement also was approved for Taxus Express2 stents with a diameter of 4 mm.

Michel Darnaud, president of Boston Scientific Europe, said the decision "will allow more patients to be treated at the private hospital level and demonstrates confidence in the long-term efficacy of the Taxus stent when used in complex lesions and diabetic patients."

At the Paris Course on Revascularization in May, Boston Scientific announced nine-month results from its European-based TAXUS VI clinical trial that supported safety and efficacy of the moderate-release formulation paclitaxel-eluting stent in high-risk patients.

Medtronic sees DES okay in near term

Medtronic Vascular (Santa Rosa, California) said in late-November that it has filed the last of its paperwork seeking CE marking of its Endeavor drug-eluting stent (DES). It added that it had been informed by European regulators that its stent-manufacturing facilities in Santa Rosa and in Galway, Ireland, had passed all quality system requirements.

A unit of Medtronic (Minneapolis), Medtronic Vascular said it is hoping to receive the CE mark, which will allow commercialization of the Endeavor DES in the European Union, by early this year.

The company earlier last year had forecast late-2004 approval of the stent in Europe.

An investigational device exemption has been filed with the FDA to begin the fourth clinical trial of the Endeavor in the U.S., with patient enrollment was expected to begin last month.

SynX gets European patent for stroke test

Nanogen (San Diego) said its SynX (Toronto) subsidiary has been issued European Patent No. 1155325, "Method for Diagnosing and Distinguishing Stroke," by the European Patent Office.

The patent relates to a diagnostic kit and method of measuring the presence of both an ischemic marker and a brain endothelial cell membrane protein to indicate that a patient has suffered a stroke and, if so, whether it was an ischemic or hemorrhagic cerebral event. In October the U.S. Patent and Trademark Office granted SynX a patent for similar claims related to the rapid, point-of-care stroke diagnostic test that the company is developing for emergency medicine.

The '325 patent covers both a method and a diagnostic kit for analyzing the levels of proteins released from the brain during a stroke. SynX said that by measuring the presence of an ischemic marker protein such as a myelin basic protein, S100 protein, neuronal specific enolase, or similar molecules, and a brain endothelial membrane protein such as thrombomodulin or a similar molecule, a physician can determine the occurrence of a stroke.

"The time that has elapsed since stroke onset can also be estimated, which is a critical value in determining if 'clot buster' drugs such as tissue plasminogen activators (tPAs) would be an effective treatment," the company said.

In addition, analyses of these proteins provide information as to the type of stroke and the extent of brain damage, thereby allowing a physician to more quickly determine the best course of treatment.

SynX said a rapid and accurate diagnostic for stroke, which permits effective treatments to be used during the critical period of time before permanent damage occurs, currently does not exist for the estimated 650,000 Europeans and 700,000 Americans a year who experience a stroke.

"This latest addition to SynX's growing patent portfolio related to its stroke diagnostic provides broader claims to valuable methods and technologies," said Howard Birndorf, Nanogen chairman and CEO. "[Its] rapid diagnostic can provide critical, timely information to assist the healthcare community to ultimately reduce the number of patients who suffer permanent neurologic damage as a result of stroke."