Cardiovascular Device Update articles from November 2004

Cardiovascular Device Update archives from November 2004

Diabetic patients benefit from DES technology, study shows.
November 1, 2004... WASHINGTON -- Drug-eluting stent (DES) technology may no longer be the new kid on the block, but there is still plenty of updated information as use of the devices expands into other indications and more data is gathered on niche populations....

Conor Medsystems reports early results from COSTAR I.(TCT notebook)
November 1, 2004... At the 16th annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington in late September, companies big and small presented compelling data from various studies for new products that they hope will lead to newly approved...

Guidant (Indianapolis) disclosed plans to conduct a study designed to increase clinical understanding of vulnerable plaques--lipid-rich coronary lesions that suddenly rupture--that may cause most heart attacks.(TCT notebook)
November 1, 2004... * Guidant (Indianapolis) disclosed plans to conduct a study designed to increase clinical understanding of vulnerable plaques--lipid-rich coronary lesions that suddenly rupture--that may cause most heart attacks. The study will include 700...

Rubicon Medical (Salt Lake City) reported that the adverse event rate 30 days following the procedures involving 51 initial patients enrolled in its RULE-Carotid, Europe study of the Rubicon filter was 6.1%.(TCT notebook)
November 1, 2004... * Rubicon Medical (Salt Lake City) reported that the adverse event rate 30 days following the procedures involving 51 initial patients enrolled in its RULE-Carotid, Europe study of the Rubicon filter was 6.1%. The RULE-Carotid study involved...

Heartlab.(TCT notebook)(Brief Article)
November 1, 2004... * Heartlab (Westerly, Rhode Island), a designer and supplier of digital image and information networks for cardiology, reported at the meeting that its CardioNow web-based technology for DICOM study sharing was used during the TCT conference to...

Cordis Endovascular (Warren, New Jersey), a division of Cordis (Miami Lakes, Florida), reported at the meeting that a patient in Newport Beach, California was the first to enroll in the company's surveillance study of its carotid artery stenting system for treatment of patients with carotid artery disease at high-risk for adverse events from carotid endarterectomy.(TCT notebook)
November 1, 2004... * Cordis Endovascular (Warren, New Jersey), a division of Cordis (Miami Lakes, Florida), reported at the meeting that a patient in Newport Beach, California was the first to enroll in the company's surveillance study of its carotid artery...

Vascular Solutions.(TCT notebook)(Brief Article)
November 1, 2004... * Vascular Solutions (Minneapolis) reported the presentation of preliminary results of the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) clinical study. Presentation of the data from the first 60 patients of the...

Edwards Lifesciences (Irvine, California) featured several interventional cardiovascular technologies at the meeting.(TCT notebook)(Brief Article)
November 1, 2004... * Edwards Lifesciences (Irvine, California) featured several interventional cardiovascular technologies at the meeting. In addition to a number of presentations on the latest developments in its percutaneous heart valve initiatives, the company...

Spectranetics (Colorado Springs, Colorado) said its products were used in two live-case sessions.(TCT notebook)(Brief Article)
November 1, 2004... * Spectranetics (Colorado Springs, Colorado) said its products were used in two live-case sessions. The first featured a 2.3 mm-diameter CliRpath excimer laser catheter recently cleared by the FDA to treat a total occlusion in the popliteal...

Siemens Medical Solutions (Malvern, Pennsylvania) reported that a live broadcast was shown from the first U.S. installation site of the Somatom Sensation Cardiac 64 computed tomography (CT) system..(TCT notebook)(Brief Article)
November 1, 2004... * Siemens Medical Solutions (Malvern, Pennsylvania) reported that a live broadcast was shown from the first U.S. installation site of the Somatom Sensation Cardiac 64 computed tomography (CT) system. Siemens was showcasing the Somatom Sensation...

Experts debate FDA 'lag time' in getting technology to market.
November 1, 2004... WASHINGTON -- As attendees at the 16th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium here in late September examined trial results and the latest trends in medical device technology, there also was an eye on the...

Edwards Lifesciences (Irvine, California) reported that it has enhanced its core heart valve business with the acquisition of all technology and intellectual property associated with ev3's (Plymouth, Minnesota) percutaneous mitral valve repair program for roughly $15 million.(Acquisitions)(Brief Article)
November 1, 2004... * Edwards Lifesciences (Irvine, California) reported that it has enhanced its core heart valve business with the acquisition of all technology and intellectual property associated with ev3's (Plymouth, Minnesota) percutaneous mitral valve...

St. Jude Medical (St. Paul, Minnesota) reported the completion of its previously disclosed acquisition of privately held Irvine Biomedical (IBI; Irvine, California), a developer of electrophysiology (EP) catheter products are used by physician specialists to diagnose and treat cardiac rhythm disorders.(Acquisitions)(Brief Article)
November 1, 2004... * St. Jude Medical (St. Paul, Minnesota) reported the completion of its previously disclosed acquisition of privately held Irvine Biomedical (IBI; Irvine, California), a developer of electrophysiology (EP) catheter products flint are used by...

Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and software solutions, reported that it was exercising its option to acquire Revivant (Sunnyvale, California), manufacturer of the AutoPulse non-invasive cardiac support pump.(Acquisitions)(Brief Article)
November 1, 2004... * Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and software solutions, reported that it was exercising its option to acquire Revivant (Sunnyvale, California), manufacturer of the AutoPulse non-invasive...

Luck, skill combined for Taxus development.(Business Developments)
November 1, 2004... If one is to believe Jim Tobin, chairman and CEO of Boston Scientific (Natick, Massachusetts), his company lucked into becoming the second company in the U.S. to have a drug-eluting stent (DES) on the market, and by his account, "king of...

Dade Behring (Deerfield, Illinois), the University of Frankfurt (Frankfurt, Germany) and Innovectis (also Frankfurt) have signed an exclusive license agreement.(Agreements)(Brief Article)
November 1, 2004... * Dade Behring (Deerfield, Illinois), the University of Frankfurt (Frankfurt, Germany) and Innovectis (also Frankfurt) have signed an exclusive license agreement that provides Dade Behring with worldwide rights for the inventions of a research...

Recom Managed Systems (Los Angeles), an emerging life sciences company focused on the monitoring and detection of disease through continuous biomedical signal monitoring, said it has entered into a sponsored research agreement with the Duke Clinical Research Institute (Durham, North Carolina) to evaluate the performance of the Recom Model 100 ambulatory ECG monitoring system.(Agreements)(Brief Article)
November 1, 2004... * Recom Managed Systems (Los Angeles), an emerging life sciences company focused on the monitoring and detection of disease through continuous biomedical signal monitoring, said it has entered into a sponsored research agreement with the Duke...

TDC Medical (Westborough, Massachusetts) reported the signing of a collaboration agreement with Creganna Medical Devices (Galway, Ireland).(Agreements)(Brief Article)
November 1, 2004... * TDC Medical (Westborough, Massachusetts) reported the signing of a collaboration agreement with Creganna Medical Devices (Galway, Ireland). The companies have agreed to use each other's resources in the design and manufacturing of medical...

Volcano Therapeutics (Rancho Cordova, California), maker of intravascular ultrasound (IVUS) products, reported an agreement to add Goodman Co. to distribute its IVUS products in Japan beginning Feb. 1.(Agreements)(Brief Article)
November 1, 2004... * Volcano Therapeutics (Rancho Cordova, California), maker of intravascular ultrasound (IVUS) products, reported an agreement to add Goodman Co. to distribute its IVUS products in Japan beginning Feb. 1. Volcano's current distributors, Fukuda...

CMS, HRS to create ICD use registry.(Market Updates)
November 1, 2004... The Centers for Medicare & Medicaid Services (CMS; Baltimore) recently asked the Heart Rhythm Society (HRS; Washington) to lead a working group to make recommendation for a national implantable cardioverter defibrillator (ICD) registry. Late in...

MedicalCV.(Personnel File)(Brief Article)
November 1, 2004... * Adam Berman has been named vice president, research and development for MedicalCV (Minneapolis). He most recently was a regional sales manager for cardiac surgery-focused Coalescent Surgical. Medical CV is focused on developing products for...

Spectranetics.(Personnel File)(Brief Article)
November 1, 2004... * Bruce Ross, executive vice president of customer and product programs at Spectranetics (Colorado Springs, Colorado), has resigned. Spectranetics is the manufacturer of the CVX-300 excimer laser, approved by the FDA for multiple minimally...

SynCardia's heart wins bridge-to-transplant OK.(Product Pipeline)
November 1, 2004... SynCardia Systems (Tucson, Arizona), a developer of cardiac replacement and assist devices, in mid-October received final FDA approval for its CardioWest Temporary Total Artificial Heart (TAH-t)--formerly the CardioWest Total Artificial...

Abbott Laboratories.(Product Pipeline)(Brief Article)
November 1, 2004... * The diagnostics division of Abbott Laboratories (Abbott Park, Illinois) has expanded the product offering for its AxSYM automated immunoassay system with an updated test for the detection of cardiac troponin. The company is now ready to...

AngioScore.(Product Pipeline)(Brief Article)
November 1, 2004... * AngloScore (Alameda, California) reported receiving the CE mark for its flagship AngioSculpt sooting balloon catheter. The AngioSculpt scoring balloon catheter is a line of coronary angioplasty catheters comprising an angioplasty balloon...

CHF Solutions (Brooklyn Park, Minnesota) said findings from two clinical trials of Aquapheresis, the company's therapy for fluid overload, were presented as posters at the recent meeting of the Heart Failure Society of America in Toronto.(Product Pipeline)(Brief Article)
November 1, 2004... * CHF Solutions (Brooklyn Park, Minnesota) said findings from two clinical trials of Aquapheresis, the company's therapy for fluid overload, were presented as posters at the recent meeting of the Heart Failure Society of America in Toronto....

Cordis Endovascular (Warren, New Jersey), a division of Cordis, a Johnson & Johnson company, reported that a patient in Newport Beach, California, is the first to enroll in its surveillance study of its carotid artery stenting system for treatment of patients with carotid artery disease at high-risk for adverse events from carotid endarterectomy.(Product Pipeline)(Brief Article)
November 1, 2004... * Cordis Endovascular (Warren, New Jersey), a division of Cordis, a Johnson & Johnson company, reported that a patient in Newport Beach, California, is the first to enroll in its surveillance study of its carotid artery stenting system for...

Cryo-Cell International (Clearwater, Florida) said that its affiliate, Saneron CCEL Therapeutics (Tampa, Florida), in collaboration with its research affiliates, published promising results using cord blood stem cells in conjunction with stroke in animal models in the October issue of Stroke.(Product Pipeline)
November 1, 2004... * Cryo-Cell International (Clearwater, Florida) said that its affiliate, Saneron CCEL Therapeutics (Tampa, Florida), in collaboration with its research affiliates, published promising results using cord blood stem cells in conjunction with...

CryoCor.(Product Pipeline)(Brief Article)
November 1, 2004... * CryoCor (San Diego) reported receiving FDA 510(k) clearance for the Breva Surgical Probe, part of its Cardiac Cryoablation System, which includes a control console and a probe/console interface. The Breva Surgical Probe is intended to be used...

diaDexus.(Product Pipeline)(Brief Article)
November 1, 2004... * diaDexus (South San Francisco, California) said a prospective cohort study of the MONICA population, a landmark 14-year population study, was published in the Oct. 5 issue of Circulation. Data from the study support the measurement of...

EP MedSystems.(Product Pipeline)(Cardiac Stimulator )(Brief Article)
November 1, 2004... * EP MedSystems (West Berlin, New Jersey) reported that it had received market clearance from the FDA for an enhancement to its EP-4 Computerized Cardiac Stimulator allowing the physician to stimulate the heart using either constant current or...

Guidant.(Product Pipeline)(Vasoview 6 Endoscopic Vessel Harvesting System)(Brief Article)
November 1, 2004... * Guidant (Indianapolis) reported the FDA clearance and U.S. launch of its Vasoview 6 Endoscopic Vessel Harvesting System for extracting vessels used by surgeons to perform coronary artery bypass procedures. The Vasoview 6 system allows the...

LuMend.(Product Pipeline)(Brief Article)
November 1, 2004... * LuMend (Redwood City, California), a developer of catheter-based technology for crossing chronic total occlusions (CTOs), reported the launch of its Outback Re-Entry Catheter. The company said its proven peripheral crossing technology, the...

Medtronic Vascular (Santa Rosa, California) reported that it has completed patient enrollment in the ENDEAVOR III clinical trial in the U.S.(Product Pipeline)(Brief Article)
November 1, 2004... * Medtronic Vascular (Santa Rosa, California) reported that it has completed patient enrollment in the ENDEAVOR III clinical trial in the U.S. The data from the ENDEAVOR III trial will be used to support U.S. product approval of the company's...

The Philips Medical Systems (Andover, Massachusetts) unit of Royal Philips Electronics reported the launch of a new generation of cardiac ultrasound equipment with high-definition imaging and on-cart data analysis tools.(Product Pipeline)(Brief Article)
November 1, 2004... * The Philips Medical Systems (Andover, Massachusetts) unit of Royal Philips Electronics reported the launch of a new generation of cardiac ultrasound equipment with high-definition imaging and on-cart data analysis tools. The iE33 intelligent...

St. Jude Medical (St. Paul, Minnesota) reported the first European implant of its new SJM Tailor Annuloplasty Band for use in heart valve repair procedures.(Product Pipeline)(Brief Article)
November 1, 2004... * St. Jude Medical (St. Paul, Minnesota) reported the first European implant of its new SJM Tailor Armuloplasty Band for use in heart valve repair procedures. The implant was performed by Professor Hans-Joachim Schafers, MD, at the University...

Siemens Medical Solutions.(Product Pipeline)(Brief Article)
November 1, 2004... * Siemens Medical Solutions (Malvern, Pennsylvania) said its Angiography and X-ray Division has introduced Interventional Cardiac 3D (IC3D) technology to create 3-D images of the coronary vessels in the heart. When paired with an Axiom Artis...

Toshiba America Medical Systems (Tustin, California) reported the details of ongoing clinical research being conducted at Beth Israel Deaconess Medical Center (Boston) to further improve the clinical application of the company's Aquilion multi-detector computed tomography (CT) system.(Product Pipeline)(Brief Article)
November 1, 2004... * Toshiba America Medical Systems (Tustin, California) reported the details of ongoing clinical research being conducted at Beth Israel Deaconess Medical Center (Boston) to further improve the clinical application of the company's Aquilion...

Trimedyne.(Product Pipeline)(Brief Article)
November 1, 2004... * Trimedyne (Irvine, California) said the U.S. Patent and Trademark Office has allowed its patent application on a new laser angioplasty device. The patent covers unique optical fiber devices designed to make smooth channels through plaque...

Vascular Solutions.(Product Pipeline)(Langston dual lumen pigtail catheter)(Brief Article)
November 1, 2004... * Vascular Solutions (Minneapolis) reported that it has received FDA 510(k) clearance for the Langston dual lumen pigtail catheter. The two-lumen diagnostic catheter is indicated for use in the simultaneous measurement of pressures from two...

Welch Allyn.(Product Pipeline)(Brief Article)
November 1, 2004... * Welch Allyn (Skaneateles Falls, New York) reported the introduction of Smartlink Wireless, a rapid response system for transmitting critical patient data from an ambulance or helicopter to a receiving hospital's cardiac care team using a...

Zargis Medical (Princeton, New Jersey), a subsidiary of Speedus, said it has received FDA clearance to include a graphical display of the median energy level, timing and duration of suspected heart murmurs during specific segments of the diastolic and systolic intervals of heartbeats recorded through the Zargis Acoustic Cardioscan.(Product Pipeline)(Brief Article)
November 1, 2004... * Zargis Medical (Princeton, New Jersey), a subsidiary of Speedus, said it has received FDA clearance to include a graphical display of the median energy level, timing and duration of suspected heart murmurs during specific segments of the...