EVToday News

Cordis Begins GREAT Study to Evaluate
Drug-Eluting Stents in Renal Arteries

Cordis Endovascular (Cordis Corporation, a Johnson & Johnson company, Miami, FL) recently announced the first implantation of a sirolimus-eluting stent as part of the GREAT Study. This European multicenter, prospective, nonrandomized, controlled trial will assess the safety and efficacy of sirolimus-eluting stents versus bare stents in treating renal artery stenosis. Fifty of the trial’s 100 patients will receive a bare, stainless steel, balloon-expandable stent, while 50 others will receive the sirolimus-eluting version of the same stent system. GREAT’s primary endpoint will be based on a 6-month angiographic assessment. Cordis’ sirolimus-eluting stent is limited by law to investigational use in the US.

ev3 Launches NITREX Nitinol Guidewires

ev3 Inc. (Plymouth, MN) recently introduced the NITREX Nitinol Guidewire to its line of products designed for peripheral interventional procedures. The new device will replace ev3’s Ultra-Select and FlexFinder Nitinol Guidewire brands. The company states that NITREX guidewires are constructed of a proprietary solid-nitinol core from proximal to distal tip and designed for maximum kink resistance and atraumatic navigation during challenging interventional cases. Among the device’s features are improved coatings, gold tungsten coils for enhanced radiopacity, new shaft stiffness options for crossing or device delivery, and a variety of tip lengths and angles.

Medtronic Begins Trial to Evaluate Carotid Stent System

Medtronic, Inc. (Santa Rosa, CA), has begun patient enrollment for its clinical trial to evaluate the safety and performance of its Exponent self-expanding carotid stent system. The trial will evaluate the Exponent in conjunction with the GuardWire Temporary Occlusion and Aspiration System, the company’s embolic protection device. The MAVErIC II (Evaluation of the Medtronic AVE Self-Expandable Carotid Stent System with Distal Protection In the Treatment of Carotid Stenosis) trial is led by coprincipal investigators Stephen R. Ramee, MD, Director of the Cardiac Catheterization Laboratory at the Ochsner Clinic Foundation, New Orleans; and Randall T. Higashida, MD, Clinical Professor of Radiology and Neurological Surgery at the University of California’s San Francisco campus. This phase of the trial will monitor the clinical status of 300 patients at 1 month, 6 months, and 1 year postprocedure.

GE Medical Systems Opens All-Digital Heart Hospital

GE Medical Systems (Waukesha, WI) has partnered with The Indiana Heart Hospital (Indianapolis, IN) and opened the nation’s first comprehensive, all-digital heart hospital. The facility, which features cardiac technology and patient information systems from GE Medical Systems, is expected to reduce medical errors by up to 80% while saving time and healthcare costs. The $60 million, 210,000-square-foot facility features the GE Centricity Information System, which the company states can integrate four types of patient information—cardiac waveforms, images, text, and data—into a single longitudinal electronic record that can span a patient’s entire lifetime.

The technology also replaces paper-based charts by directly capturing and storing information using password-protected clinical monitoring devices. This system allows medical staff to access patient information at virtually every location in the hospital. “The all-digital technology at The Indiana Heart Hospital means that physicians can have life-saving information about patients in a keystroke rather than having to wait hours or even days for critical medical records and results from previous tests or treatment,” said Michael Venturini, MD, the hospital’s Chief Medical Officer.

LuMend Cleared to Market Frontrunner CTO
Catheter for Peripheral Use

LuMend, Inc. (Redwood City, CA), has received 510(k) clearance to market its Frontrunner CTO Catheter for peripheral chronic total occlusions (CTOs). The device is designed to treat chronic total occlusion in the coronary and peripheral vasculature by facilitating rapid and reliable placement of conventional guidewires across CTOs that would otherwise require more invasive procedures. According to the company, the Frontrunner features controlled, blunt, microdissection that gently separates the atherosclerotic plaque, creating a passage through the CTO, thus enabling guidewire access. LuMend reports that the Frontrunner has been used in over 1,200 US CTO coronary procedures since it’s initial market introduction in April 2002. The company received international market clearance in October 2001.

Edwards Lifesciences Acquires JOMED’s Mitral Valve Repair Technology

JOMED N.V. (Beringen, Switzerland) recently announced that it had divested its Mitral Valve Repair System project to Edwards Lifesciences (Irvine, CA) for $20 million (USD). According to JOMED, the transaction is a major milestone in their restructuring efforts, both operationally and financially. The company will continue further negotiations with strategic and financial investors in order to secure long-term financing.

The program is currently engaged in preclinical studies in Europe. Researchers have been exploring two primary approaches to percutaneous valve repair. This acquisition, combined with Edwards’ current R&D in this area, puts Edwards in the position of now owning rights in both forms of treatment, which ultimately could be complimentary to one another.

Boston Scientific Launches Drug-Eluting Stent in Europe

On February 18, Boston Scientific Corporation (Natick, MA) announced the launch of its TAXUS paclitaxel-eluting stent system in Europe and other international markets. The stent, which gained CE Mark approval on January 21, will use the Express2 coronary stent system as its platform. The company has also announced the submission of the first of five modules of its premarket approval (PMA) application for the TAXUS stent to the FDA. The company plans to complete the PMA application in June and launch the product in the US later this year.

FDA Determined to Improve Development
and Availability of Medical Products

The FDA reports that the total number of products it approved increased in 2002, but there were fewer marketing applications and longer total approval times in some significant product areas. To address this matter, the FDA announced a plan to expedite the availability of medical technologies, as well as reduce development costs while maintaining high standards for consumer protection. The initiative involves each of the FDA’s product review centers. According to a press release, the FDA intends to achieve this goal by:
1. reducing delays and product development costs by avoiding multiple cycles of FDA review when possible through early communication and other steps that will improve the quality of new product applications;
2. improving the quality and efficiency of the review process by adopting a quality systems approach to medical product reviews; and
3. facilitating new product development by providing clearer, up-to-date guidance for particular diseases and emerging technologies.

INNERCOOL Receives FDA Clearance
for Endovascular Cooling Technology

Based on data from the recently completed TCAS clinical trial, the FDA has granted 510(k) clearance to INNERCOOL therapies (San Diego, CA) to market its Celsius Control System. According to a company press release, the system is the first endovascular device to gain FDA clearance that allows physicians to actively induce, maintain, and reverse hypothermia (mild cooling) in neurosurgical patients in surgery and recovery/intensive care. The trial compared the results of the Celsius Control System to those of cooling/warming blankets, conventional treatment methods, and to additional clinical studies in neurological applications.

“The Celsius Control System gives us the ability to safely and easily modulate body temperature in an attempt to minimize tissue damage during periods of ischemia,” said Gary K. Steinberg, MD, PhD, Lacroute-Hearst Professor and Chairman of Neurosurgery at Stanford University School of Medicine, Stanford, California. “With this technology, we can quickly induce mild hypothermia, precisely maintain body temperature at a desired level, and efficiently rewarm patients to normal body temperature.”

St. Jude Medical Plans Mid-Year Launch for Angio-Seal STS Plus

St. Jude Medical, Inc. (St. Paul, MN), is anticipating a mid-year global launch for the Angio-Seal STS Plus, its latest-generation vascular closure device. The Angio-Seal STS Plus recently received FDA approval and will be offered in both 6F and 8F configurations. The device is indicated for use in closing femoral arterial puncture sites following diagnostic or interventional catheterization procedures. The company states that the STS Plus’s new design allows for improved positioning of the insertion sheath in the artery prior to deployment, helping to ensure that the sheath is in an ideal location for setting the anchor and sealing the puncture.

Following the completion of an Investigational Device Exemption study, the FDA has approved new labeling for the company’s 6F Angio-Seal STS vascular closure devices. According to a company press release, the study showed that the device can significantly reduce the time to patient ambulation following diagnostic angiography procedures, with 35% of patients ambulating in less than 5 minutes, and the majority within 10 minutes. 

Guidant Acquires X Technologies, Inc.

Guidant Corporation (Indianapolis, IN) recently signed a definitive agreement to acquire X Technologies, Inc. (Tustin, CA). X Technologies manufactures the FX miniRAIL, a coronary device for the treatment of de novo lesions and in-stent restenosis. The device received CE Mark approval in December 2001 and is currently available in many international markets. X Technologies filed an FDA premarket approval submission in September 2002. Guidant states that the acquisition will be effective upon satisfaction of certain conditions, including US regulatory approval of the device.

Abbott Launches Drug-Eluting Stent in Europe

Following a December 2002 CE Mark approval, Abbott Laboratories (Abbott Park, IL) recently launched its Dexamet (dexamethasone-eluting) stent in Europe. Dexamet is the second CE-Marked entrant to the international drug-eluting stent market. Abbott states that the coronary device is the first and only approved stent to couple the anti-inflammatory compound dexamethasone with PC Technology, a biologically inert coating designed to mimic the body’s own chemistry and minimize its response to implanted devices.

The stent was evaluated in the STRIDE trial, a prospective, nonrandomized, European clinical trial that reportedly demonstrated that dexamethasone on a PC-coated coronary stent has a positive impact on late lumen loss (0.45 mm) and MACE (3.3%). The STRIDE trial further showed a 52.1% improvement for late lumen loss and an 80.6% improvement for 6-month MACE over results from the DISTINCT trial, which evaluated PC-coated stents without a drug coating.