Cardiovascular Device Update articles from September 2004

Cardiovascular Device Update archives from September 2004

Two drug-eluting stents on U.S. market, others on the horizon.
September 1, 2004... While only two drug-eluting coronary stents are currently cleared for sale in the U.S., numerous others are peeking over the horizon, awaiting their turn in the sun. The existing products and those that are on the way reflect a variety of...

Focusing on new ways to deal with 'the new epidemic' of CHF.(congestive heart failure)
September 1, 2004... SEATTLE -- This year's small but highly regarded "Summer in Seattle" (SIS) conference, whose stated goal is to provide a state-of-the-art perspective on the field of interventional cardiology and vascular therapies, was held here in the latter...

Reimbursement tales, investment outlook capture attention.
September 1, 2004... SAN JOSE, California -- Attendance at the 12th annual Medical Device Conference sponsored by Wilson Sonsini Goodrich & Rosati (Palo Alto, California), with events held here and up the road in Palo Alto, was up 6% from the previous year,...

Cardiac Science gets $3m UK pact for AEDs.(Report from Europe)(UK Department of Health)(automated external defibrillators )
September 1, 2004... The UK Department of Health late last month named Cardiac Science (Irvine, California) as its sole provider of automated external defibrillators (AEDs). It plans to purchase about $3 million AEDs in a contract the company said represents the...

THINCS thinks cholesterol guidelines stink.(Report from Europe)
September 1, 2004... The International Network of Cholesterol Skeptics (THINCS; Lund, Sweden), a non-profit organization of physicians, scientists and researchers, said recently revised cholesterol-lowering guidelines constitute a "major risk" to public health....

Optimistic despite setback.(Report from Europe)
September 1, 2004... Proteome Sciences (Cobham, UK) last month explained why partner Biosite (San Diego) declined to use the UK firm's biomarkers in its first stroke diagnostic device and gave an optimistic assessment of prospects for commercializing its proteomics...

4 billion [pounds sterling] in UK hospital projects.(Report from Europe)(15 new hospitals in the UK)
September 1, 2004... A 4 billion [pounds sterling] program that involves the development of 15 new hospitals in the UK was given the go-ahead by Health Secretary John Reid in late July. The new hospital developments will be funded largely through the Private...

U.S. CRO collaborates with Dutch firm.(Report from Europe)(Alquest signed partnership with MediTech Strategic Consultants)(Brief Article)
September 1, 2004... Alquest (Minneapolis), a contract research organization (CRO) specializing in medical devices, combination products and biologics, has entered into a collaborative partnership with MediTech Strategic Consultants (Vaals, the Netherlands). The...

Guidance on mobile phones in hospitals.(Report from Europe)(Brief Article)
September 1, 2004... Updated guidance on the use of mobile phones has been issued to hospitals by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). The agency said the advice takes into account developments in mobile technology and the growing...

Angiotech Pharmaceuticals (Vancouver, British Columbia), the provider of drug coatings for stents and other medical devices, closed its acquisition of NeuColl (Los Gatos, California) in an all-cash transaction of nearly $13 million.(Acquisitions)(Brief Article)
September 1, 2004... Angiotech Pharmaceuticals (Vancouver, British Columbia), the provider of drug coatings for stents and other medical devices, closed its acquisition of NeuColl (Los Gatos, California) in an all-cash transaction of nearly $13 million. Previously,...

The Aristotle Corp. (Stamford, Connecticut) reported acquiring certain business assets related to the manufacture of a number of products, primarily training manikins used in the instruction of cardiopulmonary resuscitation, from CPR Prompt (Encinitas, California).(Acquisitions)(Brief Article)(Company Profile)
September 1, 2004... The Aristotle Corp. (Stamford, Connecticut) reported acquiring certain business assets related to the manufacture of a number of products, primarily training manikins used in the instruction of cardiopulmonary resuscitation, from CPR Prompt...

Biotel (Minneapolis) reported completing the purchase of substantially all of the assets of Agility Centralized Research Services (Bannockburn, Illinois) for $240,000 in cash and up to an additional $260,000 in cash based on revenues, profits and the value of contracts generated by Biotel's newly-established subsidiary, Agility Centralized Research Services.(Acquisitions)(Brief Article)(Company Profile)
September 1, 2004... Biotel (Minneapolis) reported completing the purchase of substantially all of the assets of Agility Centralized Research Services (Bannockburn, Illinois) for $240,000 in cash and up to an additional $260,000 in cash based on revenues, profits...

MedCath (Charlotte, North Carolina), a healthcare provider focused on the diagnosis and treatment of cardiovascular disease, reported on two joint ventures to build and manage cardiac catheterization laboratories for North Carolina hospitals.(Acquisitions)(Brief Article)
September 1, 2004... MedCath (Charlotte, North Carolina), a healthcare provider focused on the diagnosis and treatment of cardiovascular disease, reported on two joint ventures to build and manage cardiac catheterization laboratories for North Carolina hospitals....

OrthoLogic (Tempe, Arizona) reported completing its acquisition of Chrysalis BioTechnology (CBI; Galveston, Texas) in a deal, valued at roughly $27.5 million, announced in late April.(Acquisitions)(Brief Article)
September 1, 2004... OrthoLogic (Tempe, Arizona) reported completing its acquisition of Chrysalis BioTechnology (CBI; Galveston, Texas) in a deal, valued at roughly $27.5 million, announced in late April. OrthoLogic paid CBI $2.5 million in cash and issued...

Synarc (Maynard, Massachusetts), a provider of specialized medical imaging and molecular marker services for global clinical trials, reported completing the acquisition of IoDP Medical Imaging Research (Paris).(Acqisitions)(Brief Article)
September 1, 2004... Synarc (Maynard, Massachusetts), a provider of specialized medical imaging and molecular marker services for global clinical trials, reported completing the acquisition of IoDP Medical Imaging Research (Paris), a provider of medical imaging...

Despite recall, Boston Sci profit up threefold.(Business Developments)(Company Profile)
September 1, 2004... Boston Scientific (Natick, Massachusetts) last month reported a "historic quarter," saying its profit in the second quarter ended June 30 nearly tripled to $313 million, boosted by strong sales of its recently approved drug-eluting stents (DES)...

Berlin Heart gets U.S. media attention.(Business Developments)(Company Profile)
September 1, 2004... For two particular reasons, 2004 has been a very good year thus far for Berlin Heart (Berlin) in the U.S. market. First, the company plans to file for a humanitarian device exemption (HDE) for its pediatric heart assist device with the...

St. Jude to add two divisions.(Business Developments)
September 1, 2004... St. Jude Medical (St. Paul, Minnesota) in late July rolled out plans to create two new divisions by the end of this year, reflecting the expansion and growth opportunities of its vascular closure, cardiology and electrophysiology product lines....

Mayo Clinic, IBM to mine health data.(Business Developments)
September 1, 2004... Electronic medical records (EMRs) are being implemented, however slowly, in many hospital and managed care systems. Meanwhile, advanced computer technology is providing the ability to identify broad developments and trends in a variety of...

Alere Medical (Reno, Nevada) said it would provide its comprehensive heart failure management program to Humana's (Louisville, Kentucky) Medicare Advantage members who suffer from advanced congestive heart failure.(Agreements)(Brief Article)
September 1, 2004... Alere Medical (Reno, Nevada) said it would provide its comprehensive heart failure management program to Humana's (Louisville, Kentucky) Medicare Advantage members who suffer from advanced congestive heart failure. Humana serves more than...

Bioheart (Weston, Florida) entered into an agreement with the Powell Gene Therapy Center at the University of Florida (Gainesville, Florida) to develop a second-generation stem cell recruiting myoblast technology that includes controlled release of angiogenic growth factors for improving blood supply.(Agreements)(Brief Article)
September 1, 2004... Bioheart (Weston, Florida) entered into an agreement with the Powell Gene Therapy Center at the University of Florida (Gainesville, Florida) to develop a second-generation stem cell recruiting myoblast technology that includes controlled...

Merit Medical Systems, (South Jordan, Utah), a manufacturer of disposable products used primarily in cardiology and radiology procedures, has signed a supplier agreement with Novation (Irving, Texas), the supply company of VHA and the University HealthSystem Consortium.(Agreements)(Brief Article)
September 1, 2004... Merit Medical Systems (South Jordan, Utah), a manufacturer of disposable products used primarily in cardiology and radiology procedures, has signed a supplier agreement with Novation (Irving, Texas), the supply company of VHA and the University...

Quinton Cardiology Systems (Bothell, Washington), which focuses on cardiology products, and Cardiac Science (Irvine, California) a manufacturer of automated public access defibrillators.(Agreements)(Brief Article)
September 1, 2004... Quinton Cardiology Systems (Bothell, Washington), which focuses on cardiology products, and Cardiac Science (Irvine, California), a manufacturer of automated public access defibrillators, entered into an agreement under which Cardiac Science...

New CMS tech group to reduce barriers.(Market Updates)
September 1, 2004... The Centers for Medicare & Medicaid Services' (CMS; Baltimore) announcement last month that it plans to create the Council on Technology and Innovation (CTI), replacing its Medicare Technology Council (MTC), is an attempt to move new...

CardiacAssist.(Personnel File)(Brief Article)
September 1, 2004... Douglas Smith, PhD, has been promoted from director of engineering to vice president of engineering for CardiacAssist (Pittsburgh, Pennsylvania). Max Klix-Saravia, formerly controller of the company, was promoted to vice president of finance....

CardioGenesis.(Personnel File)(Brief Article)
September 1, 2004... CardioGenesis (Foothill Ranch, California) has named Marvin Slepian, MD, a prominent interventional cardiologist and inventor of medical therapies and devices including a total artificial heart, as chief scientific officer. Slepian is professor...

Endologix.(Personnel File)(Brief Article)
September 1, 2004... Robert Krist has been named CFO of Endologix (Irvine, California), developer of the Powerlink System endoluminal stent graft for the minimally invasive treatment of abdominal aortic aneurysms. Krist. who previously served as CFO at CardioNet,...

MedCath.(Personnel File)(Brief Article)
September 1, 2004... Stephen Puckett, founder and chairman of MedCath (Charlotte, North Carolina), has resigned from the company's board of directors. John Casey, MedCath's president and CEO. was named to the additional post of chairman. Puckett started MedCath in...

MedicalCV.(Personnel File)(Brief Article)
September 1, 2004... Richard Kramp has resigned as president of MedicalCV (Minneapolis), a maker of devices for cardiovascular surgery. Kramp has been responsible for the company's recent development work in atrial fibrillation products.

Merci Retriever gets ischemic stroke OK.(Product Pipeline)
September 1, 2004... Privately held Concentric Medical (Mountain View, California) received clearance from the FDA in mid-August to market the Merci Retriever, the first medical device cleared by that agency to remove blood clots from the brain in patients...

Abbott Laboratories.(Product Pipeline)(Brief Article)
September 1, 2004... Abbott Laboratories (Abbott Park, Illinois) has secured 510(k) marketing clearance for a Troponin-I test for use on its newest platform, the Architect i2000 Immunoassay System and Architect ci8200 Immunochemistry System. The test was introduced...

AngioScore.(Product Pipeline)(Brief Article)
September 1, 2004... AngioScore (Alameda, California) reported the receipt of FDA approval to begin the U.S. clinical trial for its flagship AngioSculpt scoring catheter and the initiation of patient enrollment in the trial. The multicenter trial is a prospective...

Bioheart (Weston, Florida) said it has entered into an agreement with the Powell Gene Therapy Center at the University of Florida (Gainesville, Florida) to develop a second-generation stem cell recruiting myoblast technology that includes controlled release of angiogenic growth factors for improving blood supply.(Product Pipeline)
September 1, 2004... Bioheart (Weston, Florida) said it has entered into an agreement with the Powell Gene Therapy Center at the University of Florida (Gainesville, Florida) to develop a second-generation stem cell recruiting myoblast technology that includes...

CardioGenesis.(Product Pipeline)
September 1, 2004... CardioGenesis (Foothill Ranch, California), developer of surgical products and accessories used in angina-relieving transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) procedures, apparently will get...

Edwards Lifesciences.(Product Pipeline)(Brief Article)
September 1, 2004... Edwards Lifesciences (Irvine, California) reported the successful treatment of the first patient in its RESILIENT (Randomized Study Comparing the Edwards Self-Expanding LifeStent vs. Angioplasty-alone In LEsions INvolving The superficial...

Epix Medical.(Product Pipeline)(Brief Article)
September 1, 2004... Epix Medical (Cambridge, Massachusetts) said it has initiated its first human clinical trial of EP2104R, an injectable magnetic resonance imaging (MRI) contrast agent that targets blood clots, or thrombi, in the body. EP-2104R binds selectively...

Kensey Nash.(Product Pipeline)(Brief Article)
September 1, 2004... Kensey Nash (Exton, Pennsylvania) has submitted an application for 510(k) clearance for its TriActiv System to the FDA. The TriActiv, formerly called the Aegis Vortex System, is a protection system designed to prevent material or debris,...

Medtronic.(Product Pipeline)(Brief Article)
September 1, 2004... Medtronic (Minneapolis) reported FDA approval of the Attain 4194 Bipolar over-the-wire left-heart lead for use with cardiac resynchronization systems. This new steroid-eluting lead has an angled shape and can be inserted using either a...

Medtronic Vascular.(Product Pipeline)(Brief Article)
September 1, 2004... Medtronic Vascular (Santa Rosa, California) reported receiving approval from the Japanese Ministry of Health, Labor and Welfare to market the Driver Coronary Stent System in Japan. The Driver stent also received reimbursement coverage and is...

Orqis Medical.(Product Pipeline)(Brief Article)
September 1, 2004... Orqis Medical (Lake Forest, California) received FDA conditional approval to conduct a clinical trial to prove the safety and efficacy of its Cancion Cardiac Recovery System (CRS), designed to create a "rest to recovery" environment for acutely...

St. Jude Medical (St. Paul, Minnesota) reported FDA approval and first implants of the Frontier II biventricular (BiV) stimulation device.(Product Pipeline)(Brief Article)
September 1, 2004... St. Jude Medical (St. Paul, Minnesota) reported FDA approval and first implants of the Frontier II biventricular (BiV) stimulation device. The device is part of an easy-to-implant system that maintains synchrony of the left and right ventricles...

Thoratec (Pleasanton, California) said that a notice filed in the Federal Register by the Centers for Medicare & Medicaid Services last month will result in increased reimbursement for the use of ventricular assist devices (VADs) and should impact physician uptake of its VAD systems.(Product Pipeline)(Brief Article)
September 1, 2004... Thoratec (Pleasanton, California) said that a notice filed in the Federal Register by the Centers for Medicare & Medicaid Services last month will result in increased reimbursement for the use of ventricular assist devices (VADs) and should...

Ventracor (Sydney, Australia) reported the eighth implant of the VentrAssist "artificial heart" as part of a pilot trial conducted at The Alfred Hospital (Melbourne, Australia).(Product Pipeline)(VentrAssist "artificial heart")(Brief Article)
September 1, 2004... Ventracor (Sydney, Australia) reported the eighth implant of the VentrAssist "artificial heart" as part of a pilot trial conducted at The Alfred Hospital (Melbourne, Australia). Chief medical investigators Professor Don Esmore and Professor...

Viasys Healthcare (Conshohocken, Pennsylvania) reported the introduction of the VMAX Encore system for pulmonary function, cardiopulmonary stress and metabolic assessment testing.(Product Pipeline)(introduced VMAX Encore system for pulmonary function)(Brief Article)
September 1, 2004... Viasys Healthcare (Conshohocken, Pennsylvania) reported the introduction of the VMAX Encore system for pulmonary function, cardiopulmonary stress and metabolic assessment testing. Marketed through Viasys Respiratory Technologies, the VMAX...

WorldHeart.(Product Pipeline)(got approval for left ventricular assist system)(Brief Article)
September 1, 2004... WorldHeart (Ottawa, Ontario) said the FDA has approved its premarket approval supplement application for a revision to the labeling of the Novacor LVAS (left ventricular assist system) to reflect the current device reliability data available to...