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Cardiovascular Device Update articles from February 2005

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Cardiovascular Device Update archives from February 2005

Advances in diagnostics, imaging technologies for cardio disease.
February 1, 2005... NEW ORLEANS -- Early identification of individuals at risk for cardiovascular disease, including myocardial infarction, stroke and peripheral vascular disease, has become increasingly important within the past decade as advances in therapy,...

Absorbable metal stent data is presented by Belgian researchers.(ISET 2005)
February 1, 2005... Drug-eluting stent (DES) technology is the current state of the art in propping open, and keeping open, coronary and peripheral vessels. But DES doesn't equal the "Holy Grail" in treating restenosis. That goal most likely will be achieved with...

Clearly a big deal, J&J bid for Guidant raises integration questions.(ISET 2005)
February 1, 2005... Johnson & Johnson's (J&J; New Brunswick, New Jersey) blockbuster mid-December offer to purchase Guidant (Indianapolis) for a whopping $24 billion will, if completed as planned, be the biggest-ever deal in the medical device sector, as well as...

In a tale of two HIFUs, firms note progress in efforts to address AF.(ISET 2005)(Hgh-intensity focused ultrasound)
February 1, 2005... Two companies reported new developments in their high-intensity focused ultrasound (HIFU) programs for the ablation of cardiac tissue, specifically atrial fibrillation (AF)--one on the surgical side and another in the catheterization...

Engineering a 'patch for a broken heart'.(From the lab)
February 1, 2005... One of the approaches being pursued in hopes of alleviating the imbalance between organ donors and recipients in need of a transplant is the engineering of artificial organs, but artificial tissue also could be used to repair damaged organs so...

Two firms in deals for distribution in China.(International report)(Shenzhen Zhiheng Advanced Electrical Technology Co.)
February 1, 2005... CardioMag Imaging (CMI; Schenectady, New York) has signed a multi-year distribution agreement with Shenzhen Zhiheng Advanced Electrical Technology Co. (Shenzhen, China). The exclusive agreement calls for deliveries of specified numbers of CMI's...

German firm to become Biophan Europe.(International report)(Amris, a developer of MRI-safe and image-compatible solutions and biomedical devices)(Brief Article)
February 1, 2005... Biophan Technologies (West Henrietta, New York), a developer of technologies designed to improve the MRI-compatibility of medical devices, said it has agreed to acquire Amris (Castrop-Rauxel/Gelsenkirchen, Germany), a developer of MRI-safe and...

UK providing 3m [pounds sterling] for obesity fight.(International report)(Brief Article)
February 1, 2005... The UK Department of Health has budgeted 3 million [pounds sterling] of extra funding to help in the battle against obesity. Public Health Minister Melanie Johnson said the new money will be split among the nine regions of England, targeted for...

Study shows health information differences.(International report)(Brief Article)
February 1, 2005... A new study of patients with chronic conditions in Europe and the U.S. shows when patients receive health information on how to manage their condition, nearly two-thirds make proactive changes in their behavior based on this information....

Arrhythmia Research Technology (ART) and its wholly owned subsidiary, Micron Products (both Fitchburg, Massachusetts), reported the completion of the consolidation of the recently acquired New England Molders (NEM) division into the newly renovated section of its Fitchburg facilities.(Acquisitions)(Brief Article)
February 1, 2005... Arrhythmia Research Technology (ART) and its wholly owned subsidiary, Micron Products (both Fitchburg, Massachusetts), reported the completion of the consolidation of the recently acquired New England Molders (NEM) division into the newly...

Boston Scientific (Natick, Massachusetts) has agreed to acquire Advanced Stent Technologies (AST; Pleasanton, California).(Acquisitions)(Brief Article)
February 1, 2005... Boston Scientific (Natick, Massachusetts) has agreed to acquire Advanced Stent Technologies (AST; Pleasanton, California). The transaction, whose terms were not disclosed, was expected to close early this year. Since its launch in 1997, AST has...

St. Jude Medical (St. Paul, Minnesota) reported completing the acquisition of Endocardial Solutions (ESI; also St. Paul) for $11.75 per share in cash for an aggregate price of about $272 million.(Acquisitions)(Brief Article)
February 1, 2005... St. Jude Medical (St. Paul, Minnesota) reported completing the acquisition of Endocardial Solutions (ESI; also St. Paul) for $11.75 per share in cash for an aggregate price of about $272 million. St. Jude and ESI originally reported the...

CardioGenesis unveils first of its 'new tools'.(Business Developments)
February 1, 2005... CardioGenesis (Foothill Ranch, California), a developer of surgical products used in angina-relieving transmyocardial revascularization (TMR) and percutaneous myocardial channeling (PMC) procedures, reported in the latter part of December a...

Millionth Taxus DES implanted.(Business Developments)(Brief Article)
February 1, 2005... Boston Scientific (Natick, Massachusetts) in January reported the implantation of its millionth Taxus Express2 paclitaxel-eluting coronary stent system, marking an obviously important milestone for the company. The Taxus received the CE mark in...

Edwards, St. Jude pact ends litigation.(Business Developments)(Brief Article)
February 1, 2005... Edwards Lifesciences (Irvine, California), a leader in the heart valve sector, reported entering into an agreement with St. Jude Medical (St. Paul, Minnesota) resolving patent infringement litigation between them. The lawsuit in question was...

Redding cardiologists to pay $24m.(Business Developments)
February 1, 2005... In another legal matter, former cardiac care patients at Redding Medical Center (Redding, California) have reached an agreement in which four cardiologists will pay $24 million to settle claims arising from charges of unnecessary cardiac...

CMS payments increase for EECP therapy.(Business Developments)(Enhanced external counterpulsation)(Brief Article)
February 1, 2005... Vasomedical (Westbury, New York), which focuses on the non-invasive treatment and management of cardiovascular diseases, reported that changes to the Physician Fee Schedule for 2005 published recently by the Centers for Medicare & Medicaid...

CHF completes $22.9m offering.(Business Developments)
February 1, 2005... Privately held CHF Solutions (Brooklyn Park, Minnesota) has completed a $22.9 million offering of its convertible preferred stock. The company said it would use the proceeds to complete a clinical trial, called UltrafiltratioN vs. IV Diuretics...

Novoste loses two-thirds of carryforwards.(Business Developments)
February 1, 2005... Embattled vascular brachytherapy provider Novoste (Norcross, Georgia) reported last month that two-thirds of its net operating loss (NOL) carryforwards will expire unused, as the result in an analysis of cumulative changes in the ownership of...

Abiomed launches service for heart recovery.(Business Developments)(Brief Article)
February 1, 2005... Abiomed (Danvers, Massachusetts), maker of medical products designed to assist or replace the pumping function of the failing heart, reported the launch of an education and service program designed to promote heart recovery. The program...

Cardiac Sciences (Irvine, California), a manufacturer of automated external defibrillators (AEDs), said it has been selected as the exclusive provider of AEDs and comprehensive AED/CPR training and AED program management services for a citywide public access defibrillator (PAD) program launched by the city of St. Louis.(Agreements)(Brief Article)
February 1, 2005... Cardiac Sciences (Irvine, California), a manufacturer of automated external defibrillators (AEDs), said it has been selected as the exclusive provider of AEDs and comprehensive AED/CPR training and AED program management services for a citywide...

Dual-chamber pacing seen worth added cost.(Market Updates)
February 1, 2005... Pacemakers that pace the heart's upper and lower chambers are more expensive than the standard devices but they are worth the extra cost, according to a study published in Circulation, the journal of the American Heart Association (AHA;...

CVD continues as no. 1 killer in U.S.(Market Updates)(Cardiovascular disease)
February 1, 2005... Cardiovascular disease (CVD) claimed the lives of 927,448 Americans in 2002, according to the Heart Disease and Stroke Statistics-2005 Update, released by the American Heart Association in late December. This figure puts CVD as still the...

Following MI, gene repair swings into action.(Market Updates)(Brief Article)
February 1, 2005... In the most comprehensive study of its kind, new data is shedding light on the important gene expression changes that occur in the heart following myocardial infarction (MI). Data from this study--gathered by researchers at Allegheny General...

Arrhythmia Research Technology.(Personnel File)(Brief Article)
February 1, 2005... David Garrison has been promoted from chief financial officer to executive vice president of finance and CFO for Arrhythmia Research Technology (ART; Fitchburg, Massachusetts). ART, through its wholly owned subsidiary, Micron Products, produces...

Boston Scientific (Natick, Massachusetts) reported an expansion of its management structure that includes the promotion of Paul LaViolette to chief operating officer.(Personnel File)
February 1, 2005... Boston Scientific (Natick, Massachusetts) reported an expansion of its management structure that includes the promotion of Paul LaViolette to chief operating officer. LaViolette has served in several positions since joining the company in 1994,...

Nanogen.(Personnel File)(Robert Saltmarsh has been named CFO )(Brief Article)
February 1, 2005... Robert Saltmarsh has been named CFO of Nanogen (San Diego). Saltmarsh joined Nanogen as vice president of corporate development last September. In addition to participating in business development initiatives, he assumed oversight of all...

Thoratec.(Personnel File)(Brief Article)
February 1, 2005... Thoratec (Pleasanton, California) said M. Wayne Boylston, senior vice president and CFO, has resigned for personal reasons. The company said Boylston will provide assistance during the transition period. Thoratec develops products to treat...

CardioDynamics' ICG platform is cleared.(Product Pipeline)
February 1, 2005... CardioDynamics (San Diego), the primary developer of Impedance Cardiography (ICG) technology, a powerful predictor of short-term outcomes for heart failure patients, reported that its third-generation product platform, the BioZ Dx, has received...

AusAm Biotechnologies (New York) reported that its Accumin test for detection of the protein albumin in urine would be offered by Quest Diagnostics (Tetersboro, New Jersey).(Product Pipeline)(Brief Article)
February 1, 2005... AusAm Biotechnologies (New York) reported that its Accumin test for detection of the protein albumin in urine would be offered by Quest Diagnostics (Tetersboro, New Jersey). The presence of relatively high levels of albumin in the urine, a...

Biotronik (Lake Oswego, Oregon) reported the first implant for a clinical investigation designed to demonstrate efficacy of both its Stratos LV and Protos DR/CLS (closed loop stimulation) pacemakers in congestive heart failure (CHF) patients.(Product Pipeline)(Brief Article)
February 1, 2005... Biotronik (Lake Oswego, Oregon) reported the first implant for a clinical investigation designed to demonstrate efficacy of both its Stratos LV and Protos DR/CLS (closed loop stimulation) pacemakers in congestive heart failure (CHF) patients...

Cardiome Pharma (Vancouver, British Columbia) and its co-development partner, Fujisawa Healthcare (Deerfield, Illinois), reported results from their recently completed Phase III multi-center clinical study, ACT 1.(Product Pipeline)(Brief Article)
February 1, 2005... Cardiome Pharma (Vancouver, British Columbia) and its co-development partner, Fujisawa Healthcare (Deerfield, Illinois), reported results from their recently completed Phase III multi-center clinical study, ACT 1. ACT 1 measured the safety and...

Cholestech (Hayward, California) reported the results of a Mayo Clinic (Rochester, Minnesota) study that suggests that a non-invasive fingertip test for which it is the distributor can identify coronary disease at its earliest stages and may provide a new point-of-care test for physicians to use in their offices.(Product Pipeline)(Brief Article)
February 1, 2005... Cholestech (Hayward, California) reported the results of a Mayo Clinic (Rochester, Minnesota) study that suggests that a non-invasive fingertip test for which it is the distributor can identify coronary disease at its earliest stages and may...

Corautus Genetics (Atlanta) reported the publication of pre-clinical results of its gene transfer technology administered via drug-eluting stents.(Product Pipeline)(Brief Article)
February 1, 2005... Corautus Genetics (Atlanta) reported the publication of pre-clinical results of its gene transfer technology administered via drug-eluting stents. In a separate project, Corautus' technology is being tested in a Phase lib trial, GENASIS...

CoreValve SA (Paris) reported that it has received approval from the German government (Bezirksregierung Koln, state of Nordrhein-Westfalen, Cologne) to begin a clinical trial of its ReValving System to non-surgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery.(Product Pipeline)(Brief Article)
February 1, 2005... CoreValve SA (Paris) reported that it has received approval from the German government (Bezirksregierung Koln, state of Nordrhein-Westfalen, Cologne) to begin a clinical trial of its ReValving System to non-surgically replace diseased aortic...

CryoCath Technologies.(Product Pipeline)(Brief Article)
February 1, 2005... CryoCath Technologies (Montreal) said additional data on a feasibility study using its Arctic Circler Balloon catheter to treat atrial fibrillation (AF) was presented at the Boston Atrial Fibrillation Symposium Jan. 15. Of 16 patients who...

CryoLife.(Product Pipeline)(Brief Article)
February 1, 2005... CryoLife (Kennesaw, Georgia), a biomaterials and biosurgical device company, unveiled updated results from its registry that tracks the clinical performance of its cryopreserved human heart valve allografts, used to project long-term...

Dade Behring (Deerfield, Illinois) reported FDA clearance for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism (deep vein thrombosis or pulmonary embolism).(Product Pipeline)(Brief Article)
February 1, 2005... Dade Behring (Deerfield, Illinois) reported FDA clearance for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism (deep vein thrombosis or pulmonary embolism). The clearance included performance data with...

Edwards Lifesciences (Irvine, California) said it previewed its FloTrac sensor, a new minimally invasive hemodynamic monitoring device, at the Society of Critical Care Medicine's 34th Critical Care Congress last month in Phoenix.(Product Pipeline)(Brief Article)
February 1, 2005... Edwards Lifesciences (Irvine, California) said it previewed its FloTrac sensor, a new minimally invasive hemodynamic monitoring device, at the Society of Critical Care Medicine's 34th Critical Care Congress last month in Phoenix. The Edwards...

MedicalCV.(Product Pipeline)(Brief Article)
February 1, 2005... MedicalCV (Minneapolis) said it received FDA 510(k) clearance to market its AtriLaze Surgical Ablation System for use on cardiac tissue in surgery. The company expected to begin marketing its AtriLaze System via a direct U.S. sales force in...

Medtronic (Minneapolis) reported the first patient enrollment in a new controlled clinical study to evaluate the safety and efficacy of a procedure in which a heart surgeon uses saline-irrigated radio frequency (RF) ablation technology to treat atrial fibrillation (AF) at the same time they repair or replace a diseased or damaged heart valve.(Product Pipeline)(Brief Article)
February 1, 2005... Medtronic (Minneapolis) reported the first patient enrollment in a new controlled clinical study to evaluate the safety and efficacy of a procedure in which a heart surgeon uses saline-irrigated radio frequency (RF) ablation technology to treat...

Noven Pharmaceuticals.(Product Pipeline)(Brief Article)
February 1, 2005... Noven Pharmaceuticals (Miami) reported that it has been issued U.S. patent No. 6,805,878, titled "Transdermal administration of ACE inhibitors." The patent relates to a method for delivering a therapeutically effective amount of enalaprilat,...

SonoSite (Bothell, Washington), a leader in handheld ultrasound systems, said that it has begun customer shipments of the SonoCalc IMT software, enabling physicians to quickly measure the wall thickness (IMT) of the common carotid arteries and assess a patient's risk of cardiovascular disease.(Product Pipeline)(Brief Article)
February 1, 2005... SonoSite (Bothell, Washington), a leader in handheld ultrasound systems, said that it has begun customer shipments of the SonoCalc IMT software, enabling physicians to quickly measure the wall thickness (IMT) of the common carotid arteries and...

Terumo Cardiovascular Systems (Ann Arbor, Michigan) has introduced the VirtuoSaph Endoscopic Vein Harvesting (EVH) System for use in coronary artery bypass grafting (CABG).(Product Pipeline)(Brief Article)
February 1, 2005... Terumo Cardiovascular Systems (Ann Arbor, Michigan) has introduced the VirtuoSaph Endoscopic Vein Harvesting (EVH) System for use in coronary artery bypass grafting (CABG). The minimally invasire device provides an endoscopic approach to...

By a vote of 8-2, with one abstention, the FDA's Circulatory System Devices panel in mid-January recommended approval, with a small number of conditions, for the Gore TAG Thoracic Endoprosthesis, developed by W. L. Gore & Associates (Flagstaff, Arizona).(Product Pipeline)(Brief Article)
February 1, 2005... By a vote of 8-2, with one abstention, the FDA's Circulatory System Devices panel in mid-January recommended approval, with a small number of conditions, for the Gore TAG Thoracic Endoprosthesis, developed by W. L. Gore & Associates (Flagstaff,...

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