A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium Taxus Element paclitaxel-eluting stent system compared to the Taxus Express2 paclitaxel-eluting stent System. The results also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the Taxus compared to a historical control group of patients receiving the Express bare-metal stent.

Analysis of the data was presented at the American College of Cardiology (ACC; Washington) Annual Scientific Sessions during a late-breaking trial session by Dean Kereiakes, MD, medical director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center (Cincinnati) and the principal investigator for the PERSEUS clinical program.

"We are very encouraged by the one-year data demonstrating positive safety and efficacy outcomes for the Taxus Element Stent and its innovative platinum chromium alloy," said Kereiakes. "In my experience, the Taxus Element Stent offers increased flexibility, visibility and deliverability compared with currently available products. The PERSEUS data confirm that the proven Taxus drug and polymer combination has been successfully transferred to the Element platform with excellent performance and comparable safety."

The Taxus is designed specifically for coronary stenting. The stent architecture and platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system, according to the company.

The company received CE mark approval for the Promus Element stent system in October 2009 and expects CE mark approval for the Taxus Element stent system in 2Q10.

Boston Scientific also reported results from an analysis of one-year subset data from the HORIZONS AMI trial assessing the impact of diabetes on clinical and angiographic outcomes in heart attack patients treated with the Taxus Express2 Paclitaxel-Eluting stent system or the Express bare-metal stent. The results demonstrated that the Taxus Express significantly reduced ischemia-driven target lesion revascularization (TLR) at one year and binary in-stent restenosis at 13 months in diabetic patients experiencing an acute myocardial infarction (AMI, or heart attack) compared to an otherwise identical bare-metal control stent.

"Results from the HORIZONS AMI trial showed impressive efficacy benefits at one year for diabetic AMI patients treated with the TAXUS Express Stent when compared to bare-metal stents," said Keith Dawkins, MD, senior VP and CMO for Boston Scientific. "The data also showed comparable safety outcomes for Taxus Express and bare-metal stents in diabetic patients. This study provides important data to physicians regarding the use of drug-eluting stents in high-risk AMI patients, especially those with diabetes, during the early hours of a heart attack. We are proud to support this and other large clinical trials that provide the medical community data that can be used in combination with broader clinical judgment to develop optimal treatment strategies for challenging patient subsets."

In other news from ACC:

• Royal Philips Electronics (Amsterdam, the Netherlands) has highlighted a range of technology advancements. The PageWriter TC70 is a cardiograph featuring the DXL 16-lead ECG algorithm. Additionally, it includes advanced ST segment elevation myocardial infarction (STEMI) decision-support tools, as well as updated gender, age, and lead-specific STEMI criteria that meet the latest AHA/ACC/HRS recommendations for acute ischemia and infarction.

The TC70 provides access to additional information that can speed analysis and triage for any patient experiencing acute infarction and ischemia symptoms. Its 1-2-3 operation lets clinicians perform ECGs quickly, the company said.

• Accumetrics (San Diego), maker of the VerifyNow system, a point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, reported the presentation of a 2,000 patient meta-analysis examining patient response to antiplatelet therapy after percutaneous coronary intervention (PCI). Data from the patient-level meta-analysis show that individuals with an inadequate response to clopidogrel have a higher incidence of major adverse cardiac events. The VerifyNow is used in various clinical settings where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke.

The analysis showed results consistent with previous publications on the clinical use and importance of assessing response to antiplatelet therapy using the VerifyNow P2Y12 platelet function test, including the recently published POPular trial.

• Abbott (Abbott Park, Illinois) reported positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott's bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) and a very low rate of major adverse cardiac events at 30 days. Abbott's investigational BVS is made of polylactide, a biocompatible material that is used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized by the body, and is completely dissolved over time. Since a permanent implant is not left behind, a vessel treated with BVS has the ability to ultimately move, flex and pulsate similar to an untreated vessel.

• Siemens (Erlangen, Germany) has introduced what it calls the ultimate hybrid, the Artis zeego, a multi-axis system that the company said enables variable working height and unparalleled positioning freedom, without impacting the laminar air flow field. The Artis zeego is part of the Artis zee family of interventional imaging in cardiology, radiology, and surgery. syngo DynaCT Cardiac, available with all Artis zee systems, supports cross-sectional 3-D images of the beating heart via rotational angiography.

The Artis zeego is available with a small detector, which enables cardiologists to have optimized visualization of the heart while achieving steeper angles. The medical grade large display further enhances our solution offering with a full-color, 56-inch screen where users can select their preferred screen layout for the planned procedure at tableside, Siemens said.