• Cordis(Miami Lakes, Florida), a Johnson & Johnson (New Brunswick, New Jersey) company, said that the FDA has approved a condition of use for the Cypher sirolimus-eluting coronary stent, allowing patients receiving the stent to immediately undergo MRI following implantation. This means patients no longer have to wait two months after a procedure with the Cypher stent before undergoing an MRI, the company said. Approval was granted after laboratory studies demonstrated the Cypher stent is MRI-safe.

• Medicure (Winnipeg, Manitoba), a cardiovascular drug discovery company, said that it received a recommendation from an independent data safety monitoring board to continue its Phase II/III MEND-CABG trial. The recommendation is based on the board’s recent review of the safety data in the majority of patients who have completed 30 days of treatment following coronary artery bypass graft (CABG) surgery. The MEND-CABG clinical trial is evaluating the cardioprotective and neuroprotective effects of MC-1 in patients undergoing high-risk CABG surgery. The Phase II portion of the study will enroll up to 900 patients. The primary endpoint of the placebo-controlled, double-blinded study is the reduction in combined incidence of cardiovascular and cerebrovascular death, non-fatal myocardial infarction and non-fatal cerebral infarction, up to and including 30 days following CABG surgery.

• MIV Therapeutics (Vancouver, British Columbia) said it received “encouraging” reports from independent researchers evaluating the company’s multi-platform/multi-drug delivery solution in short-term animal studies. The independent porcine studies evaluated the company’s hydroxyapatite (HAp)-based coatings designed for drug-eluting cardiovascular stents and other implantable medical devices. The studies were conducted on stents coated with a combination of HAp and Paclitaxel-eluting non-polymeric composite coating. “In summary, stents coated with hydroxyapatite and Paclitaxel have shown uncompromised biocompatibility and safety at 19 days,” said Dr. Greg Kaluza, scientific director of the Cardio-vascular Intervention Core at the Methodist Hospital Research Institute, who directed the study. “The low amount of neointima produced by these stents ranks with the performance of the best contemporary bare-metal stents and some drug-eluting stents described in literature utilizing a similar experimental setting. The excellent biocompatibility of the hydroxyapatite coating formulation demonstrated in the earlier study has not been adversely affected by the addition of Paclitaxel. This is important because addition of drug to a coating may irreversibly change the overall coating properties and, hence, its biocompatibility.”

• MultiCell Technologies (Warwick, Rhode Island), a supplier of non-tumorigenic immortalized human hepatocytes, said that the U.S Patent and Trademark Office granted the company U.S. patent No. 6,872,389 for its liver stem cell invention of Dr. Ronald Faris, the company’s chief science officer. The patent contains 24 claims to a method of obtaining a population of liver cell clusters. The cells can be used as the biological component of perfusion devices or liver assist devices, such as the Sybiol synthetic bio-liver device patented by MultiCell’s Xenogenics subsidiary.

• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its QuickSite 1056T bipolar lead. The lead is used in CRT (cardiac resynchronization therapy) applications for heart failure patients and will be launched in the U.S. market in advance of the Heart Rhythm 2005 Scientific Sessions that begins May 4. QuickSite leads offer a polyurethane-insulated body that transitions to a distal silicone-insulated tip section designed for optimal pushability, torque transfer and tip flexibility; a steerable, S-shaped distal tip designed to improve maneuverability and anchoring of the lead at distal as well as more proximal locations within the coronary sinus; and a choice of either a ball-tipped guiding stylet or a guidewire during the same implant for maximum flexibility in lead placement. The lead also features a radiopaque suture sleeve that enhances visibility on fluoroscopy without blocking visibility of the underlying coils; and a grooved, circumferential tip electrode designed to enhance stability and thresholds. The QuickSite 1056T bipolar lead is designed for use with the St. Jude Medical Epic HF CRT-D the Atlas+ HF CRT-D.