Siemens Medical Solutions (Iselin, New Jersey) introduced the Soarian Cardiology information solution at last month's American College of Cardiology gathering. Soarian Cardiology builds on Siemens' Soarian health information solution, which was introduced last October. It is designed to address the specific clinical, financial and operational workflow challenges of a cardiac care team. It allows users to build a comprehensive electronic medical record that includes medications, lab results, images, ECG, physiological waveforms and documentation.
Soarian Cardiology can be used departmentally or in conjunction with the enterprisewide Soarian health information system, providing real-time integration with the complete enterprise patient record.
Tim Attebery, CEO of South Carolina Heart Center, the beta site for Soarian Cardiology, said Soarian's workflow technology and intelligent user interface "is unlike anything we have ever seen for a health care information system."
Elsewhere in the product pipeline:
AtCor Medical (Sydney, Australia) received FDA approval to market its SphygmoCor Px Aortic BP profile system, a cardiovascular evaluation tool. It noninvasively measures the blood pressure profile in the ascending aortic artery. The physicians' office device, which assesses arterial stiffness and its impact on cardiac function, was already approved in Europe and Japan. It allows physicians to track changes in arterial stiffness, left ventricular load, coronary artery perfusion pressures, cardiac timing and cardiac reserve.
Bacchus Vascular (Santa Clara, California) was granted 510(k) clearance from the FDA to market its Trellis Infusion Catheter, a percutaneous system designed to facilitate the delivery of physician specified agents, including thrombolytics, into the peripheral vasculature. Earlier last month, the company received CE mark certification for the device. Trellis technology is based on a patented vibratory pharmacomechanical platform that permits extremely efficient, localized mixing of infused fluids. The Trellis System is used in conjunction with routinely used interventional procedures, done over a guidewire and through an introducer sheath.
Collateral Therapeutics (San Diego, California) said the American Heart Association (AHA; Dallas, Texas) issued a press release featuring results from the Phase I/II trial for Generx, which appeared in a rapid access issue of Circulation. The AHA said that "transferring growth factor genes into the heart appears safe and shows promise for treating the debilitating chest pain known as angina." Generx (Ad5-FGF4), a non-surgical angiogenic gene therapy, is being evaluated as a potential treatment for patients with stable exertional angina due to coronary artery disease.
Guidant (Indianapolis, Indiana) reported CE mark approval of the Easytrak 2 lead, its next-generation heart failure therapy lead using its transvenous over-the-wire design. Easytrak 2 builds on the original Easytrak lead, adding a dual-electrode design for multiple programming options including bipolar pacing and sensing. Its dual-electrode design provides increased flexibility in using the programmable pacing and sensing options available in the Contak Renewal device. Pacing leads deliver therapy from the pulse generator to the heart and send information back to the device. The Easytrak 2 lead design allows physicians to position the pacing electrodes in a vein on the left side of the heart using an over-the-wire technique similar to the system used in angioplasty procedures. Easytrak 2, in conjunction with leads implanted in the right side of the heart, allows a device from Guidant's Contak Renewal family of heart failure pulse generators to independently sense and stimulate the left and right sides of the heart.
Life Medical Sciences (Oceanport, New Jersey) began the feasibility clinical trial on its Repel-CV bioresorbable adhesion barrier. The product is designed to reduce the formation of scar tissue on the surface of the heart after open-heart surgery. The FDA-approved trial will assess the efficacy of Repel-CV in preventing and reducing adhesion formation in neonatal patients who require a staged series of open-heart surgical procedures as well as provide additional data on the product's safety profile. Post-operative adhesion formation is a prevalent and serious complication experienced in the approximately 1 million open-heart surgical procedures performed annually worldwide.
Medtronic (Minneapolis, Minnesota) released the 2.75 mm S660 Coronary Stent System with Discrete Technology, which recently received premarket approval from the FDA as well as CE mark approval in Europe. The system will be immediately available to physicians for use in small-vessel stenting procedures. The S660 stent system, first introduced to the market in April 2000 in a 2.5-mm size, is designed for use in vessels that are 2.2 mm to 2.9 mm in diameter. It is indicated for use in abrupt or threatened closure of vessels and is designed for post-percutaneous transluminal coronary angioplasty deployment. Of that figure, Medtronic said about 20% involve the treatment of small vessels (less than 3.0 mm). Like its slightly smaller predecessor, the 2.75 mm S660 stent system incorporates six-crown architecture, a metal-to-artery ratio and strut thickness optimized for use in small vessels.
Merit Medical Systems (South Jordan, Utah), which manufactures disposable products used in cardiology and radiology procedures, introduced the One-Step centesis catheter and the Inject8 Palm Pad syringe. Centesis catheters are used in a number of procedures to drain fluid from cavities within the body such as the abdomen, chest and lungs. One-Step is one of three catheters planned for release this year. The Inject8 Palm Pad is an additional model in the company's line of Inject8 coronary control syringes. Inject8 requires up to 40% less injection force because of its smaller barrel size, making it ideal for injecting contrast media by hand through smaller catheters.
SonoSite (Bothell, Washington) reported results of a study examining the effectiveness of the SonoSite 180 system in detecting blockages in carotid (neck) arteries during the American Stroke Association's 27th International Stroke Conference in San Antonio, Texas. The study, conducted at Wake Forest University (Winston-Salem, North Carolina), screened carotid arteries using the SonoSite 180 system in a prospective study of 51 patients. The degree of blockage in these patients was estimated by measuring the area ratio and the diameter ratio with 89.7% accuracy (area ratio) and 84.3% accuracy (diameter ratio) in detecting severe blockages of carotid arteries. The SonoSite 180 system can be carried by the examiner to the screening site in a backpack, rather than requiring the patient to go to an imaging center, such as a radiology department.
St. Jude Medical (St. Paul, Minnesota) said it received FDA approval for the SJM Regent heart valve, the company's newest mechanical heart valve. St. Jude said the SJM Regent valve offers "exceptional structural integrity, durability and low complication rates." It features what St. Jude called "subtle design modifications" to its pyrolytic carbon components, "resulting in unprecedented hemodynamic performance." The heart valve has been marketed in Europe and Canada since 1999, and St. Jude said it now makes up a significant percentage of the company's aortic valve sales mix in the international markets where it is available.
TomTec Imaging Systems (Munich, Germany), a developer of 3-D and 4-D ultrasound technology, introduced Image-Arena, a suite of solutions for digital image management in echocardiography. The company said the solution supports the cardiologist in reading patient studies, performing offline cardiac measurements and generating reports. Image-Arena acquires, stores and retrieves image data of most ultrasound manufacturers systems in DICOM and non-DICOM image formats. Side-by-side comparison of serial studies is supported by a synchronized play function. Frank Schlau, senior vice president of sales and marketing, said Image-Arena "reflects customers' demands to increase productivity in the echocardiography lab. This new solution provides additional clinical information like our 3-D and 4-D products and improves efficiency within the echo-lab."