A Medical Device Daily

GE Healthcare (Waukesha, Wisconsin) and Boston Scientific (Natick, Massachusetts), at the Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium this week in Washington, reported a collaboration focused on improving intravascular ultrasound (IVUS) workflow between the GE Healthcare Innova Cardiovascular X-ray System and the Boston Scientific's iLab Ultrasound Imaging System. The iLab and Innova Systems are both being featured at the TCT gathering.

GE Healthcare says that the Innova help physicians to visualize fine vessels, precisely place stents and perform critical procedures. Cardiologists use it when performing procedures in the cath lab to view and treat potential coronary artery blockages that could cause heart attacks or other cardiovascular damage.

Jayant Saha, general manager, Interventional Global Marketing for GE Healthcare, said, "IVUS has proved to be an important and indispensable diagnostic tool in interventional cardiology. Boston Scientific, a leading IVUS solutions provider, and GE look forward to offering the technological advances in the field of IVUS to our joint customers ... ."

Boston Scientific's iLab Ultrasound Imaging System can be directly installed into the cardiac catheterization lab or radiology suite alongside the GE Innova X-ray System, enabling physicians to readily incorporate IVUS technology into their procedures. With IVUS, a tiny catheter is inserted into the heart or into a vessel where high-frequency sound waves reflect off tissue or vessel walls. The reflected sound waves create a cross-sectional image from within the vessel or heart to aid in visualizing vessel and heart structure.

Additionally, visitors to GE Healthcare's exhibit at TCT got a glimpse into the future of interventional cardiology, including the Innova cardiovascular X-ray system, aided by the new Innova Dose, Innova 3-D and Innova with Stent Technologies features. Designed to further improve on the industry's leading dose efficiency technologies, GE's Innova Dose package delivers superb image quality and custom dose management, according to the company.

Intended to enhance, but not replace, 2D fluoroscopic imaging, the Innova 3-D imaging technique aids in acquiring and reconstructing 3-D cardiac anatomy images right in the cath lab. Innova with Stent Technologies simplifies lesion assessment and provides exceptional stent visualization, with one-button activation and can be fully integrated with Innova IVUS systems.

In other news from the TCT symposium:

• Abbott (Abbott Park, Illinois) reported two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent (DES) successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries.

Patients who received Abbott's bioabsorbable DES and followed out to two years experienced no stent thrombosis and no new major adverse cardiac events (MACE) between six months and two years.

These results confirmed earlier positive one-year clinical results, Abbott said.

• Medtronic (Minneapolis) reported that of those treated with its Endeavor Resolute DES in the RESOLUTE IDE trial only two patients required repeat procedures a 1.5% rate of target lesion revascularization (TLR) at two years following implant.

There were no instances of stent thrombosis among the 130 study subjects, all receiving an Endeavor Resolute DES, through 24 months of follow-up.

"The goal of the RESOLUTE clinical program is to extend the proven long-term safety and durable efficacy benefits that our flagship Endeavor DES offers to patients who are underserved by currently available treatment alternatives," said Sean Salmon, VP and general manager of Medtronic's Coronary and Peripheral Vascular business. "The Resolute DES will complement our coronary stent portfolio as we seek to address the unmet clinical needs of patients at high risk of restenosis."

Medtronic also released new data from the ENDEAVOR clinical program that reinforces the strong performance of the company's Endeavor drug-eluting stent (DES) across diverse patient populations affected by coronary artery disease.

One-year results from the ENDEAVOR-Five registry including those for subsets of diabetics and patients with acute myocardial infarction demonstrate that the Endeavor DES performs comparably in a real-world population of patients with complex disease and in specific patient subsets, the company said.

• Boston Scientific (Natick, Massachusetts) reported results from an analysis of nearly 7,500 patients from its TAXUS ARRIVE 1 and 2 registries, designed to confirm the performance of the Taxus Express2 Paclitaxel-Eluting Coronary Stent System in real-world practice. The two-year pooled ARRIVE data showed that the Taxus stent reduced restenosis in patients with diabetes as effectively as in patients without diabetes, with no incremental risk of myocardial infarction (MI) or stent thrombosis.

"The ARRIVE diabetic subset data demonstrated that the Taxus stent mitigated the adverse effect of diabetes as a risk factor for restenosis and repeat procedures in the patients studied," said John Lasala, MD, professor of medicine at Washington University School of Medicine (St. Louis). "While the diabetic patients had more cardiac risk factors, comorbidity and higher mortality than non-diabetics, the rates of reintervention, MI and stent thrombosis in the ARRIVE 1 and 2 registries were similar in both groups, regardless of risk profile."

Boston Scientific also reported data from the TAXUS ATLAS clinical program, a series of global, prospective, multi-center, single-arm controlled trials, which evaluate the Taxus liberté paclitaxel-eluting stent system in a variety of lesions and patient groups.

"The TAXUS ATLAS studies reinforce the long-term safety and efficacy of the TAXUS Liberté Stent while demonstrating the ability to access complex lesions. The data showed significantly reduced restenosis in small vessels and positive results in direct stenting procedures," said Mark Turco, MD, director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital (Takoma Park, Maryland), and co-principal investigator of the trial. "The positive ATLAS data suggest that improvements in stent design and a reduction in strut thickness may contribute to improved clinical outcomes for patients treated with the TAXUS Liberté stent."