Cardiovascular Device Update articles from April 2003

Cardiovascular Device Update archives from April 2003

Healthcare system searches for solutions to costs, other problems. (CDU at the UC Irvine Health Care Forecast Conference).(medical technology can offset rising health care costs)
April 1, 2003... Irvine, California -- Inefficiencies, inequities, escalating costs and issues of access within the U.S. healthcare system have continued to challenge both the public and private sectors for well over a decade. Healthcare costs entered a new...

Ischemic stroke focus is on widening the therapeutic window. (CDU at the AHA's International Stroke Conference).(various articles on stroke treatment)
April 1, 2003... Phoenix, Arizona -- Ischemic stroke accounts for 80% to 85% of the estimated 750,000 strokes that occur annually in the U.S. Thus, it was no surprise that at this year's International Stroke Conference, sponsored annually by the American Heart...

Gene transfer inefficient in aged cardiac muscle. (From the Lab).
April 1, 2003... With the salient risk factor for development of cardiovascular disease being advancing old age, research cardiologist Roger Hajjar notes that efforts to develop gene therapy for heart disease "have been geared toward the elderly, since they...

Ethics advisors urge greater scrutiny of ads for genetic tests. (Report from Europe).
April 1, 2003... The explosion of Internet-based advertising for genetic tests has provoked a sharp reaction from the European Union's top advisers on ethics. They issued a call for caution last month and promised to investigate the matter closely. The...

CardioTech International (Woburn, Massachusetts) said it would complete the acquisition of Gish Biomedical (Rancho Santa Margarita, California) by April 7. (Acquisitions).(CardioTech International Inc.)(Gish Biomedical Inc.)(Brief Article)
April 1, 2003... CardioTech International (Woburn, Massachusetts) said it would complete the acquisition of Gish Biomedical (Rancho Santa Margarita, California) by April 7. The value of the stock-for-stock deal has not been disclosed. Gish shares will be...

Guidant (Indianapolis, Indiana) last month signed a definitive agreement to buy certain assets of Biosensors International's (Singapore) everolimuscoated stent program for $20 million in cash, plus potential milestone payments and royalties. (Acquisitions).(Brief Article)
April 1, 2003... Guidant (Indianapolis, Indiana) last month signed a definitive agreement to buy certain assets of Biosensors International's (Singapore) everolimuscoated stent program for $20 million in cash, plus potential milestone payments and royalties....

Abiomed moves ahead on heart-assist devices. (Business Developments).(various articles on product development and enhancement)(Abiomed Inc.)
April 1, 2003... Abiomed (Danvers, Massachusetts) last month rolled out plans to develop a new line of ventricularassist devices, suggesting both a return to its initial development effort and an "inflection point" in its progress with the AbioCor replacement...

AST Products (Billerica, Massachusetts), a developer of water-based coatings for medical devices, has completed a licensing agreement with MicroPort Medical (Shanghai, China) for its LubriLAST coating. (Agreements).(AST Products Inc.)(Brief Article)
April 1, 2003... AST products (Billerica, Massachusetts), a developer of water-based coatings for medical devices, has completed a licensing agreement with MicroPort Medical (Shanghai, China) for its LubriLAST coating. AST also opened a new coating facility in...

InHealth Group (High Wycombe, UK) and CTI Molecular Imaging (Knoxville, Tennessee) said they will partner to advance the availability of positron emission tomography (PET) and molecular imaging in order to improve disease diagnosis and therapy management for patients in the UK. (Agreements).(CTI Molecular Imaging Inc.)(Brief Article)
April 1, 2003... InHealth group (High Wycombe, UK) and CTI molecular imaging (Knoxville, Tennessee) said they will partner to advance the availability of positron emission tomography (PET) and molecular imaging in order to improve disease diagnosis and therapy...

Q-Med (Eatontown, New Jersey) said it would implement its heart failure management program with CHA Health (Lexington, Kentucky). (Agreements).(QMed Inc.)(Brief Article)
April 1, 2003... Q-Med (Eatontown, New Jersey) said it would implement its heart failure management program with CHA Health (Lexington, Kentucky). The program will focus on physician and patient compliance using Q-Med's best practice, evidence-based medicine...

ARF a key women's heart surgery risk. (Market Updates).(acute renal failure )(various articles on mortality risk, sleep apnea and heart disease treatment)
April 1, 2003... Women who undergo open-heart surgery are more likely than men to develop acute renal failure (ARF), according to research conducted at The Cleveland Clinic (Cleveland, Ohio). ARF is a serious complication of open-heart surgery and is strongly...

C.R. Bard. (Personnel File).(C.R. Bard Inc. Bard Electro Medical Systems names new chief financial officer and vice president)(Brief Article)
April 1, 2003... Todd Schermerhorn has been named senior vice president and chief financial officer of C.R. Bard (Murray Hill, New Jersey), replacing Charles Slacik, who has resigned. Schermerhorn has held a succession of financial management positions at Bard,...

Datascope. (Personnel File).(Datascope Collagen Products Div.)(chief executive officer selected)(Brief Article)
April 1, 2003... Murray Pitkowsky, senior vice president of Datascope (Montvale, New Jersey), will resume his former position of chief financial officer. He replaces Leonard Goodman, who will continue to be employed by the company for the next year to assist...

Guidant. (Personnel File).(Guidant Corp.)(employee promotions)(Brief Article)
April 1, 2003... Dana Mead Jr. has been promoted from vice president, corporate relations and policy, to president, vascular intervention, for Guidant (Indianapolis, Indiana). Mead replaces John Capek, who has accepted a post leading a new business venture...

Recom Managed Systems. (Personnel File).(Brief Article)
April 1, 2003... Lowell Harmison, PhD, is joining Recom Managed Systems (Los Angeles, California) as senior advisor. Harmison, former principal deputy assistant secretary of health for the U.S. Public Health Service, developed the first completely implantable...

Panel's Freezor OK comes with conditions. (Product Pipeline).(Freezor cardiac cryoablation catheter)
April 1, 2003... Senior management at CryoCath Technologies (Montreal, Quebec) was elated over the result of an FDA advisory panel meeting last month, despite a list of conditions the company must now address. The agency's Circulatory System Devices Panel...

Abiomed. (Product Pipeline).(ABIOMED Inc.)(enhancement of blood pump system)(Brief Article)
April 1, 2003... Abiomed (Danvers, Massachusetts) said that the FDA has completed its review of the company's premarket approval supplement requesting approval of a new drive and control system for its BVS product line. The FDA has determined that the...

Acusphere. (Product Pipeline).(Acusphere Inc.)(clinical trial of an ultrasound contrast agent)(Brief Article)
April 1, 2003... Acusphere (Watertown, Massachusetts) has initiated a Phase III clinical study of AI-700, an ultrasound contrast agent designed for detecting coronary artery disease in patients with ischemic heart disease. The Phase III program began recently...

Boston Scientific. (Product Pipeline).(Boston Scientific Corp. tests safety of drug infusion implant)
April 1, 2003... Boston Scientific (Natick, Massachusetts) said it has started its TAXUS V clinical trial, which plans to evaluate more than 1,100 patients at up to 70 sites in the U.S. The first patients were enrolled earlier this month in the de novo lesion...

Cardima. (Product Pipeline).(Cardima Inc.)(product approval in progress)(Brief Article)
April 1, 2003... Cardima (Fremont, California) said that its premarket approval application for the Revelation Tx will be reviewed during a May 29 meeting of the FDA Circulatory System Devices Panel. The company further reported that its manufacturing facility...

CardioVations (Somerville, New Jersey), a division of Ethicon (also Somerville), introduced the Myolift Heart Retractor and the Flexsite Heart Stabilizer, instruments that help position the heart and stabilize the coronary artery during cardiac surgery. (Product Pipeline).(Brief Article)
April 1, 2003... CardioVations (Somerville, New Jersey), a division of Ethicon (also Somerville), introduced the Myolift Heart Retractor and the Flexsite Heart Stabilizer, instruments that help position the heart and stabilize the coronary artery during cardiac...

Coalescent Surgical (Sunnyvale, California) said that the first sutureless mitral annuloplasty repair was performed last month by W. Randolph Chitwood Jr., MD, chief of cardiothoracic surgery at the Brody School of Medicine at East Carolina University (Greenville, North Carolina). (Product Pipeline).(Coalescent Surgical Inc.)(Brief Article)
April 1, 2003... Coalescent Surgical (Sunnyvale, California) said that the first sutureless mitral annuloplasty repair was performed last month by W. Randolph Chitwood Jr., MD, chief of cardiothoracic surgery at the Brody School of Medicine at East Carolina...

Cybernet Medical (Ann Arbor, Michigan) said that its MedStar data transmission device is being used in a pilot study of congestive heart failure (CHF) patients in Geneva County, Alabama. (Product Pipeline).(Brief Article)
April 1, 2003... Cybernet Medical (Ann Arbor, Michigan) said that its MedStar data transmission device is being used in a pilot study of congestive heart failure (CHF) patients in Geneva County, Alabama. The six-month study is evaluating the effectiveness of...

Endologix. (Product Pipeline).(Endologix Inc.)(clinical trials)(Brief Article)
April 1, 2003... Endologix (Irvine, California) said it enrolled the 190th patient in the pivotal trial of its PowerLink System, a minimally invasive treatment for abdominal aortic aneurysms (AAA). The company plans to use the data from the study to move...

ev3. (Product Pipeline).(surgical wires)(Brief Article)
April 1, 2003... ev3 (Minneapolis, Minnesota) introduced Nitrex Nitinol Guidewires offering a streamlined guidewire product line specifically for peripheral interventional procedures. Nitrex Guidewires will replace ev3's Ultra-Select and FlexFinder Nitinol...

Guidant. (Product Pipeline).(Guidant Corp. tests safety of implantable defibrillator)(Brief Article)
April 1, 2003... Guidant (Indianapolis, Indiana) reported the first U.S. implant in its latest heart failure study, DECREASE HF (Device Evaluation of Contak Renewal 2 and Easytrak 2-Assessment of Safety and Effectiveness in Heart Failure). The study is designed...

HemoSense's (Milpitas, California) INRatio Prothrombin Time (PT) Monitoring System is being released for sale in the U.S. for patient self-testing at home and for use by medical professionals. (Product Pipeline).(HemoSense Inc.)(Brief Article)
April 1, 2003... HemoSense's (Milpitas, California) INRatio Prothrombin Time (PT) Monitoring System is being released for sale in the U.S. for patient self-testing at home and for use by medical professionals. INRatio tests and records the clotting time of...

Immersion (San Jose, California) reported two agreements with Medtronic (Minneapolis, Minnesota). (Product Pipeline).(Immersion Corp.)(Medtronic Inc.)(licensing and product development agreements)(Brief Article)
April 1, 2003... Immersion (San Jose, California) reported two agreements with Medtronic (Minneapolis, Minnesota). These agreements define and fund development projects and provide licensing rights for use of Immersion's intellectual property related to medical...

MacroPore Biosurgery. (Product Pipeline).(MacroPore Biosurgery Inc. receives patent for scar prevention material)(Brief Article)
April 1, 2003... MacroPore Biosurgery (Frankfurt, Germany/ San Diego, California) said U.S. patent No. 6,531,146 has been issued for the company's bioresorbable thin film, SurgiWrap. The U.S. Patent and Trademark Office has allowed all of the claims in the...

Nanogen. (Product Pipeline).(Brief Article)
April 1, 2003... Nanogen (San Diego, California) said it has commercially released the first multiplex Analyte Specific Reagent (ASR), designed for the detection of Factor V Leiden and Factor II prothrombin gene mutations associated with cardiovascular disease...

Neoprobe (Dublin, Ohio) received notification from the U.S. Patent and Trademark Office of the allowance of a second patent covering the products of its Cardiosonix subsidiary. (Product Pipeline).(Neoprobe Corp.)(Brief Article)
April 1, 2003... Neoprobe (Dublin, Ohio) received notification from the U.S. Patent and Trademark Office of the allowance of a second patent covering the products of its Cardiosonix subsidiary. The patent covers key aspects of the ADBF technology as well as...

NMT Medical (Boston, Massachusetts) reported receiving conditional approval from the FDA for its pivotal clinical trial to evaluate the effectiveness of transcatheter closure of a common cardiac defect using the company's StarFlex cardiac septal repair implant, compared to best medical therapy. (Product Pipeline).(NMT Medical Inc.)(Food and Drug Administration)
April 1, 2003... NMT Medical (Boston, Massachusetts) reported receiving conditional approval from the FDA for its pivotal clinical trial to evaluate the effectiveness of transcatheter closure of a common cardiac defect using the company's StarFlex cardiac...

Novoste. (Product Pipeline).(Novoste Corp.)(investigational device exemption)(Brief Article)
April 1, 2003... Novoste (Norcross, Georgia) received FDA approval for a supplement to its investigational device exemption that will permit patient enrollment in the modified version of the BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow)...

OmniSonics Medical Technologies (Wilmington, Massachusetts), developer of products based on the OmniWave Technology platform to treat vascular occlusive disease, said that the latest data on its Resolution System was presented at the Society of Interventional Radiology's 28th annual scientific meeting in Salt Lake City, Utah. (Product Pipeline).(OmniSonics Medical Technologies Inc.)(Brief Article)
April 1, 2003... OmniSonics Medical Technologies (Wilmington, Massachusetts), developer of products based on the OmniWave Technology platform to treat vascular occlusive disease, said that the latest data on its Resolution System was presented at the Society of...

Orbus Medical Technologies (Fort Lauderdale, Florida) said that Michael Kutryk, MD, PhD, an interventional cardiologist at St. Michael's Hospital (Toronto, Ontario), presented his group's latest results on circulating endothelial progenitor cell (EPC).(Brief Article)
April 1, 2003... Orbus Medical Technologies (Fort Lauderdale, Florida) said that Michael Kutryk, MD, PhD, an interventional cardiologist at St. Michael's Hospital (Toronto, Ontario), presented his group's latest results on circulating endothelial progenitor...

Quinton Cardiology Systems. (Product Pipeline).(rolls out new Atria 3000 ECG under the Burdick brand name)(Brief Article)
April 1, 2003... Quinton Cardiology Systems (Bothell, Washington) has started shipping the new Atria 3000 ECG under the Burdick brand name. The compact, easy-to-use system is designed primarily for use in physicians' practices. This electrocardiograph is the...

Rafael Medical Technologies. (Product Pipeline).(begins clinical trials evaluating the mechanical aspects and safety of its SafeFlo retrievable vena cava filte)(Brief Article)
April 1, 2003... Rafael Medical Technologies (Caesarea, Israel) reported the start of clinical trials evaluating the mechanical aspects and safety of its SafeFlo retrievable vena cava filter for the prevention of pulmonary embolism, and the VascuGrasp, its...

St. Jude Medical (St. Paul, Minnesota) reported the first implant of its new Riata single-coil defibrillation lead. (Product Pipeline).(St. Jude Medical Inc.)(Brief Article)
April 1, 2003... St. Jude Medical (St. Paul, Minnesota) reported the first implant of its new Riata single-coil defibrillation lead. The first implant of the Riata single-coil defibrillation lead was performed in February at Queen Mary Hospital in Hong Kong by...

Stereotaxis (St. Louis, Missouri) reported that the Baptist Heart Institute at Central Baptist Hospital (Lexington, Kentucky) has performed the first robotic catheterization procedure using the Niobe Magnetic Navigation System.(Stereotaxis Inc.)(Brief Article)
April 1, 2003... Stereotaxis (St. Louis, Missouri) reported that the Baptist Heart Institute at Central Baptist Hospital (Lexington, Kentucky) has performed the first robotic catheterization procedure using the Niobe Magnetic Navigation System, a recently...

Thoratec (Pleasanton, California) reported that the Medicare Coverage Advisory Committee (MCAC) voted favorably last month on two questions presented to it by the Centers for Medicare & Medicaid Services (CMS) regarding Medicare coverage for the use of Left Ventricular Assist Devices (LVADs) for destination therapy, with the company's HeartMate VE being the only such device currently FDA-approved for that application. (Product Pipeline).(Thoratec Laboratories Corp.)
April 1, 2003... Thoratec (Pleasanton, California) reported that the Medicare Coverage Advisory Committee (MCAC) voted favorably last month on two questions presented to it by the Centers for Medicare & Medicaid Services (CMS) regarding Medicare coverage for...

WorldHeart. (Product Pipeline).(WorldHeart Corp. enhances left ventricular assist system)(Brief Article)
April 1, 2003... WorldHeart (Ottawa, Ontario) has made a submission to Health Canada requesting approval for enhancements to its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients' quality of life by...