St. Jude Medical Inc. announced that the company's EnligHTN(TM) Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after one year. The new one year study data from the EnligHTN I trial was presented at EuroPCR 2013 in Paris. Renal denervation is a minimally invasive, catheter-based ablation procedure used to treat patients with drug-resistant hypertension (or high blood pressure). A series of radiofrequency (RF) energy ablations are administered to create lesions (tiny scars) along the renal sympathetic nerves -- a network of nerves that help control blood pressure. Typically, normal blood pressure is at or below 120 systolic and 80 diastolic, which is expressed as 120 /80 mmHg. Hypertension is categorized as a blood pressure reading greater than 140 /90 mmHg. It is important to note that the risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure. Patients enrolled in the EnligHTN I trial had an average blood pressure of 176 /96 mmHg and patients were drug-resistant, meaning their blood pressure could not be controlled through medication. At one year, patients treated with the EnligHTN Renal Denervation System experienced an average systolic blood pressure reduction of 27 mmHg points when measured in an office setting. One Year Study Findings: An average systolic blood pressure reduction of 27 mmHg points was reported; 80% of patients responded to the therapy defined as a blood pressure reduction of at least 10 mmHg when measured during an office visit; The longer-term safety profile for renal denervation was supported by showing no significant changes in kidney function. A prospective, multi-center feasibility study, the EnligHTN I trial treated 46 patients whose blood pressure was considered drug resistant despite taking three or more antihypertensive medications including a diuretic. To qualify for the study, patients had a systolic blood pressure greater than or equal to 160 mmHg (150 mmHg for patients with type 2 diabetes). Patients in the trial will continue to be followed for a total of two years post procedure. The EnligHTN system is a multi-electrode ablation technology for renal denervation. Using the new EnligHTN system, an ablation catheter delivers radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves -- a network of nerves that help control blood pressure. The intentional disruption of the nerve supply has been clinically found to cause a decrease in systolic and diastolic blood pressure. With its unique basket design, each placement of the ablation catheter administers a predictable treatment pattern. The non-occlusive basket design allows for continuous blood flow to the kidney during the procedure. Compared to single-electrode ablation systems, the four-point contact of the multi-electrode EnligHTN system has the potential to improve procedural accuracy, save time as well as result in workflow and cost efficiencies. The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to produce effective lesions. Additionally, minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (X-ray) exposure.

St. Jude Medical Inc. announced CE Mark approval of its ILUMIEN(TM) OPTIS(TM) PCI Optimization System(TM), a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease (CAD). The system will be on display for the first time in Europe during EuroPCR. 3-D image of a stent inside a coronary artery taken using the ILUMIEN(TM) OPTIS(TM). The ILUMIEN OPTIS system provides enhancements to the ILUMIEN(TM) system, including first-of-its-kind stent planning software tools to aid in the treatment of CAD. The ILUMIEN platform integrates both Fractional Flow Reserve (FFR) technology to measure pressure inside the coronary arteries and intravascular Optical Coherence Tomography (OCT) imaging technology, in one system. Featuring a faster, high-powered laser, the ILUMIEN OPTIS system offers twice the resolution for microscopic examination of disease inside the artery to assist with stent placement. The real-time, three-dimensional (3-D) reconstruction offers a 360-degree panoramic view of the vessel, making it easier for physicians to visualize the area they are treating. St. Jude Medical is the only company to provide these tools together in an integrated platform. OCT technology has become increasingly important to help diagnose and treat patients with coronary artery disease. The ILUMIEN OPTIS system is a significant advancement in intravascular imaging technology allowing physicians to comprehensively assess more vessel in less time and more easily plan their PCI procedure. The three-dimensional format of the ILUMIEN OPTIS system provides a more true-to-life perspective of the arteries, which allows for individual decision making and precise guidance of stent placement to optimize coronary interventions, said Dr. Giulio Guagliumi, Cardiovascular Department of Ospedale Papa Giovanni XXIII, Bergamo, Italy. The OCT technology in the new ILUMIEN OPTIS system uses the Dragonfly(TM) Duo Imaging Catheter to capture near-infrared light imaging and measure important vessel characteristics otherwise invisible or difficult to assess with older imaging technology. When used with the ILUMIEN OPTIS system, the Dragonfly Duo catheter offers faster, longer pull-backs, which allow the physician to assess more of the patient's artery in less time. The wireless PressureWire(TM) Aeris(TM) technology that is integrated into the platform measures pressure differences in blood flow within the coronary arteries leading to the heart, and determines the severity of any narrowings or blockages. The FFR pressure guidewire is directed along the vessel, taking measurements as the guidewire is pulled back through the artery. Knowing which specific blockages are causing the patient's blood flow to be ineffective helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs. The FFR and OCT measurements captured by the ILUMIEN OPTIS system allow physicians to more easily differentiate plaque build-up and determine if the narrowed arteries are causing ischemia, ultimately assisting in stent placement. The automated stent planning tools provide immediate information for assessment and real-time analysis, which is intended to streamline workflow, potentially helping physicians diagnose their patients more quickly.

St. Jude Medical Inc. announced enrollment of the first patient in the EnligHTN III trial. This study will evaluate the safety and performance of the new second-generation EnligHTN(TM) Renal Denervation System in patients with drug-resistant, uncontrolled hypertension. The next-generation system utilizes the proven multi-electrode catheter paired with a new generator that features a high-tech, icon-friendly, touch screen user interface that provides simultaneous ablations using four electrodes. This advancement reduces total ablation time from approximately 24 minutes to four minutes. With its unique non-occlusive basket design, each placement of the ablation catheter using the EnligHTN system administers a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure. Additionally, the new second-generation EnligHTN generator allows physicians to easily view and record procedure information. The EnligHTN III study is an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand with drug-resistant hypertension, meaning their high blood pressure could not be controlled through medication. To qualify for the study, participants must have systolic blood pressure that remains greater than 160 mmHg as measured during office visits, despite the use of three antihypertensive medications concurrently at the maximum tolerated doses, one of which is a diuretic. This study expands upon the research conducted in the EnligHTN I trial of the first generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was reduced by an average of 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment. Renal denervation is a minimally invasive, catheter-based ablation procedure used to treat patients with drug-resistant hypertension (or high blood pressure). The EnligHTN systems deliver radiofrequency (RF) energy from an ablation catheter to create lesions (tiny scars) along the renal nerves -- a network of nerves thought to help control blood pressure. The intentional disruption of the nerve supply has been clinically found to cause systolic and diastolic blood pressure to decrease. Typically, normal blood pressure is below 120 systolic and 80 diastolic, which is expressed as 120 /80 mmHg. Hypertension is categorized as a blood pressure reading greater than 140 /90 mmHg.