A Medical Device Daily

Medtronic (Minneapolis) reported the consistency and quality of the long-term clinical results for the Endeavor drug-eluting stent (DES) continue to distinguish it as a treatment for coronary artery disease, according to newly released data.

Five-year findings from the comprehensive ENDEAVOR program were released Monday at ACC.10, the American College of Cardiology's (Washington) 59th Scientific Session. Medtronic said the E-Pooled analysis – which now includes five-year data from the ENDEAVOR I (E-I), ENDEAVOR II (E-II), E-II Continued Access (CA), and ENDEAVOR III (E-III) clinical studies, and three-year data from the ENDEAVOR IV (E-IV) and ENDEAVOR Pharmacokinetics (E-PK) clinical studies – demonstrates striking consistency in clinical results across multiple studies. Notable findings include a very low rate of late repeat revascularization events and a paucity of very late stent thrombotic events with 8,799 patient-years of follow up.

“The consistency of results across these well conducted clinical trials is remarkable,“ said David Kandzari, MD, director of interventional cardiology research at Scripps Clinic (La Jolla, California), and co-principal investigator of E-III and E-IV. “The Endeavor stent has demonstrated a very compelling safety and efficacy profile wherein there is a very low likelihood that patients treated with the Endeavor stent will experience late stent clotting or the need for a repeat procedure beyond the first year of follow up.“

Medtronic also reported data from the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial during late-breaking sessions at ACC.10. The data showed superiority over anti-arrhythmic drugs, with 69.9% of patients with paroxysmal atrial fibrillation (PAF) treated with the Arctic Front® Cardiac CryoAblation Catheter System remaining free of atrial fibrillation (AF) one year after cryoablation, compared to 7.3% on drug therapy. All primary safety and effectiveness endpoints in the trial were met. The Arctic Front catheter is available for use in Europe and is under investigational use in the U.S.

The Medtronic Arctic Front Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional electroanatomical mapping systems.

In other news from ACC.10:

• GE Healthcare (Waukesha, Wisconsin) introduced the MARS Virtual Sleep Lab (VSL), which the company claims is the first device to provide a streamlined view of quantitative cardiac and sleep apnea analysis from any GE-monitored inpatient bed, helping enhance speed of diagnosis.

“With MARS VSL, hospitals can quickly and effectively test cardiac patients for sleep apnea, utilizing existing physiological data for retrospective analysis,“ said Matthias Weber, MD, VP/GM of global diagnostic cardiology at GE Healthcare. “Eliminating this delay in sleep apnea diagnosis supports GE's healthymagination vision for enhancing outcomes, enabling timely access to treatment and ultimately, reducing costs.“

MARS VSL automatically reports on clinical data that is critical for making a sleep apnea diagnosis, such as apnea hypopnea index, sleep staging and respiratory events. Following a sleep apnea diagnosis, an AutoPAP device can be immediately prescribed while the patient is still in the hospital. This increases the chance that OSA patients can begin treatment before other complications develop.

• St. Jude Medical (St. Paul, Minnesota) reported several updates to its PressureWire platform, including a new marketing agreement with Siemens Medical Solutions (Atlanta), for the wireless PressureWire Aeris. St. Jude says the enhanced capabilities make the company's fractional flow reserve (FFR) measurement technology, which aids in the diagnosis and treatment of coronary artery blockages, more versatile and accessible for physicians around the world.

The PressureWire Aeris and Certus provide FFR measurements, which indicate the severity of blood flow blockages in the coronary arteries. This physiological measurement helps physicians to better identify which specific lesion or lesions are responsible for a patient's ischemia, a deficiency of blood supply to the heart caused by blood restriction.

St. Jude Medical's new agreement with Siemens will enable integrated wireless FFR measurement with PressureWire Aeris as an upgrade to hospitals using the Siemens AXIOM Sensis XP. The AXIOM Sensis XP is a hemodynamic recording systems in cath labs and offers advanced measurement programs which aid physicians in interventional procedures.

FFR is an index determining the functional severity of narrowings in the coronary arteries, and it is measured by PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient's heart muscle (called ischemia), and guides the interventional cardiologist in assessing which lesions warrant coronary interventions which results in improved treatment outcomes.

• Toshiba America Medical Systems (Tustin, California) introduced the InfinixTM VF-i biplane system with two identical 12'' x 12'' flat panel detectors and the CAT 880B hybrid catheterization table.

The mid-sized flat panel detector expands the versatility of the Infinix-i line, which features a five-axis C-arm positioner and enables unprecedented patient access and coverage. The new mid-sized flat panel detector covers more anatomical area in one view. The ability to see more anatomy in one view reduces C-arm movement or table panning and decreases overall procedure time. The flexible system easily accommodates acquiring all standard views of the heart and is also beneficial when imaging anatomy outside the heart. Toshiba said.

Along with the new mid-sized detector, the Infinix-i five-axis systems are now available with the new CAT 880B tilt/cradle hybrid catheterization table. This table is designed to allow greater positioning flexibility and patient access during imaging and surgery. The table functionality with side-to-side cradle and head-to-toe tilt permits clinicians to angle the table in the optimal position to quickly complete procedures. The flexibility and ergonomic design enhance the clinicians' ability to work around the patient and accommodate views that conventional angiographic tables cannot achieve.