Cardiovascular Device Update articles from March 2004

Cardiovascular Device Update archives from March 2004

Boston Sci's Taxus approval tops news from big cardio companies.
March 1, 2004... The largest cardiovascular companies had plenty of news to crow about in the latter part of February and early March as they jockeyed for position in various key sectors of the cardiovascular device market. Boston Scientific (Natick,...

Carotid artery stenting seen ready to play a larger role vs. strokes.
March 1, 2004... SAN DIEGO, California -- Compared to the sunny weather outside, attendees at the 29th annual International Stroke Conference inside the beautiful San Diego Convention Center in early February were confronted with the ongoing frustrations of...

'Intelligent' system detects earliest signs of a heart attack.
March 1, 2004... A Canadian company has created a device that it says can detect a heart attack up to eight minutes before a patient experiences symptoms of the attack, then can alert emergency medical staff and direct them to the patient's exact location. The...

Cytokine plays a role in septic shock damage.(Report from Europe)
March 1, 2004... The cytokine interleukin-6 plays an important role in triggering the rapid damage to heart muscle function that can develop in people with septic shock following infection with meningococci, a condition that often is fatal. The team making that...

Guidant (Indianapolis, Indiana) has completed its acquisition of AFx (Fremont, California), a portfolio company of Alta Partners.(Acquisitions)
March 1, 2004... Guidant (Indianapolis, Indiana) has completed its acquisition of AFx (Fremont, California), a portfolio company of Alta Partners. AFx will receive an upfront cash payment of $45 million and various predetermined milestone payments. Focused on...

Nanogen (San Diego, California), a developer of molecular diagnostics for the gene-based testing market, has its sights set on expansion into the point-of-care (POC) diagnostics sector with the acquisition of SYN X Pharma (Toronto, Ontario) in a proposed deal.(Acquisitions)
March 1, 2004... Nanogen (San Diego, California), a developer of molecular diagnostics for the gene-based testing market, has its sights set on expansion into the point-of-care (POC) diagnostics sector with the acquisition of SYN X Pharma (Toronto, Ontario) in...

OmniSonics raises $43m in 'C' funding.(Business Developments)
March 1, 2004... OmniSonics Medical Technologies (Wilmington, Massachusetts), a developer of medical devices to treat vascular occlusive disease, last month reported the final close of its Series C round of financing, producing an aggregate total of $43 million...

Applied Medical (Rancho Santa Margarita, California) said it has been awarded a supplier agreement with Premier (San Diego, California) for endomechanical kits, ligation systems and trocars.(Agreements)
March 1, 2004... Applied Medical (Rancho Santa Margarita, California) said it has been awarded a supplier agreement with Premier (San Diego, California) for endomechanical kits, ligation systems and trocars. The contract is the third supplier agreement between...

Edwards Lifesciences (Irvine, California) has entered into an alliance with PLC Medical Systems (Franklin, Massachusetts) to commercialize products for the surgical treatment of cardiac arrhythmias.(Agreements)
March 1, 2004... Edwards Lifesciences (Irvine, California) has entered into an alliance with PLC Medical Systems (Franklin, Massachusetts) to commercialize products for the surgical treatment of cardiac arrhythmias. Under the exclusive, multi-year agreement,...

NMT Medical (Boston, Massachusetts) and the National Stroke Association (NSA; Englewood, Colorado) said that the two organizations have joined forces to promote the education and understanding of cryptogenic stroke and transient ischemic attack (TIA) in young patients.(Agreements)
March 1, 2004... NMT Medical (Boston, Massachusetts) and the National Stroke Association (NSA; Englewood, Colorado) said that the two organizations have joined forces to promote the education and understanding of cryptogenic stroke and transient ischemic attack...

Vascular Solutions (Minneapolis, Minnesota) has entered into an agreement with B. Braun Medical (Bethlehem, Pennsylvania) providing for the inclusion of Vascular Solutions' D-Stat Dry hemostatic bandage with B. Braun Medical's vena cava filter kits sold in the U.S.(Agreements)
March 1, 2004... Vascular Solutions (Minneapolis, Minnesota) has entered into an agreement with B. Braun Medical (Bethlehem, Pennsylvania) providing for the inclusion of Vascular Solutions' D-Stat Dry hemostatic bandage with B. Braun Medical's vena cava filter...

Bar codes for drugs; devices to follow.(Market Updates)
March 1, 2004... Manufacturers of drugs and certain over-the-counter medications used in hospitals have been given two years to include linear bar codes on product labels. The requirement is designed to protect patients from preventable medication errors and to...

Abiomed.(Personnel File)
March 1, 2004... Abiomed (Danvers, Massachusetts) reported several recent hires. Kim Byrum Chappell joins the company as a clinical field consultant. Most recently, she was employed by Jewish Hospital, one of the clinical sites for the clinical trial of...

Neil Treister, MD, has been selected by CardioDynamics (San Diego, California) to fill the newly created position of medical director.(Personnel File)
March 1, 2004... Neil Treister, MD, has been selected by CardioDynamics (San Diego, California) to fill the newly created position of medical director. Treister's current clinical practice focuses on preventive and consultative cardiology in both the office and...

SurModics.(Personnel File)
March 1, 2004... Steven Keough has been named rice president and chief intellectual property counsel for SurModics (Eden Prairie, Minnesota). Before joining SurModics, Keough practiced law at Fredrikson & Byron, where he was a senior member and past chairman of...

CoolSystems works on cooling 'helmet'.(Product Pipeline)
March 1, 2004... Those who suffer from stroke--and ultimately those with head trauma, brain injury of in cardiac arrest--may in the not-too-distant future have another weapon in the physician arsenal to fight brain swelling, the result of disease or injury that...

AngioDynamics.(Product Pipeline)
March 1, 2004... AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM (Lake Success, New York), reported FDA clearance for its SpeedLyser infusion catheter--the first infusion catheter designed for dissolving thrombus from a blocked...

Biosite (San Diego, California) said it has received clearance from the FDA to market the Triage BNP Test for Beckman Coulter Immunoassay Systems, a diagnostic test that measures B-type natriuretic peptide (BNP).(Product Pipeline)
March 1, 2004... Biosite (San Diego, California) said it has received clearance from the FDA to market the Triage BNP Test for Beckman Coulter Immunoassay Systems, a diagnostic test that measures B-type natriuretic peptide (BNP). The Triage BNP Test for Beckman...

Biotronik.(Product Pipeline)
March 1, 2004... Biotronik (Lake Oswego, Oregon) said the FDA has approved interactive Internet access to the Biotronik Home Monitoring early detection system. Available for both implantable cardiac defibrillators and pacemakers, it is the first early detection...

Boston Scientific.(Product Pipeline)
March 1, 2004... Boston Scientific (Natick, Massachusetts) said it has received the CE mark for its new coronary stent, the Liberte. The company said it plans to launch the stent immediately in Europe and other international markets, and in the U.S. in the...

CardioDynamics (San Diego, California), the developer of Impedance Cardiography (ICG) technology, reported the publication of an ICG hypertension study in the February issue of Congestive Heart Failure showing a 57% blood pressure control rate in previously uncontrolled hypertensive patients in a generalist physician setting.(Product Pipeline)
March 1, 2004... CardioDynamics (San Diego, California), the developer of Impedance Cardiography (ICG) technology, reported the publication of an ICG hypertension study in the February issue of Congestive Heart Failure showing a 57% blood pressure control rate...

CardioGenesis (Foothill Ranch, California) said that "conclusive new data" on the long-term benefits of angina-relieving transmyocardial revascularization (TMR).(Product Pipeline)
March 1, 2004... CardioGenesis (Foothill Ranch, California) said that "conclusive new data" on the long-term benefits of angina-relieving transmyocardial revascularization (TMR), when performed in conjunction with coronary artery bypass grafting (CABG) surgery...

Chase Medical (Richardson, Texas) said results of a study on heart failure patients who received its TRISVR (tri-saver) surgery were presented at the Society of Thoracic Surgeons meeting in San Antonio, Texas.(Product Pipeline)
March 1, 2004... Chase Medical (Richardson, Texas) said results of a study on heart failure patients who received its TRISVR (tri-saver) surgery were presented at the Society of Thoracic Surgeons meeting in San Antonio, Texas. The TRISVR procedure, a surgical...

CHF Solutions (Brooklyn Park, Minnesota) reported that the Minnesota Heart Failure Consortium (MHFC; Minneapolis, Minnesota), a non-profit research organization, has launched a clinical study of the company's System 100 Fluid Removal System, a mechanical pump/ultrafiltration system that removes excess fluid from fluid-overloaded patients.(Product Pipeline)
March 1, 2004... CHF Solutions (Brooklyn Park, Minnesota) reported that the Minnesota Heart Failure Consortium (MHFC; Minneapolis, Minnesota), a non-profit research organization, has launched a clinical study of the company's System 100 Fluid Removal System, a...

CryoCath Technologies (Montreal, Quebec) said that multiple abstracts and a symposium pertaining to the ablation of atrial fibrillation (AF) using the company's SurgiFrost CryoSurgical Ablation System were presented at the fourth annual Surgical Treatment of AF Conference in late January in San Antonio, Texas.(Product Pipeline)
March 1, 2004... CryoCath Technologies (Montreal, Quebec) said that multiple abstracts and a symposium pertaining to the ablation of atrial fibrillation (AF) using the company's SurgiFrost CryoSurgical Ablation System were presented at the fourth annual...

Dade Behring.(Product Pipeline)
March 1, 2004... Dade Behring (Deerfield, Illinois) said it has received clearance from the FDA for use of its N High Sensitivity CRP assay as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. When used...

Digirad.(Product Pipeline)
March 1, 2004... Digirad (San Diego, California) reported the release of its OptiCount collimator, which increases the organ sensitivity of Digirad's nuclear cardiology imaging systems by an average of 15% per detector head, while maintaining the same level of...

Edwards Lifesciences (Irvine, California) reported the launch of two new heart valve products in the U.S. at the 40th annual scientific meeting of the Society of Thoracic Surgeons in San Antonio, Texas.(Product Pipeline)
March 1, 2004... Edwards Lifesciences (Irvine, California) reported the launch of two new heart valve products in the U.S. at the 40th annual scientific meeting of the Society of Thoracic Surgeons in San Antonio, Texas. The Perimount Magna valve was recently...

Endologix.(Product Pipeline)
March 1, 2004... Endologix (Irvine, California) has received U.S. patent No. 6,660,030 B2, "Bifurcation Graft Deployment Catheter," and No. 6,663,665 B2, "Single Puncture Bifurcation Graft Deployment System." These devices are used to deploy Endologix's...

GenVec.(Product Pipeline)
March 1, 2004... GenVec (Gaithersburg, Maryland) reported the issuance of U.S. patent No. 6,673,604, titled "Muscle Cells and Their Use in Cardiac Repair," which covers transplantable skeletal myoblast compositions (muscle cells) that can be used to treat any...

Guidant.(Product Pipeline)
March 1, 2004... Guidant (Indianapolis, Indiana) has launched its Acrobat SUV (Swivel, Universal, Vacuum) Stabilizer System for beating-heart surgery. The Acrobat SUV Stabilizer System is the next-generation addition to the established Acrobat line of...

Medtronic.(Product Pipeline)
March 1, 2004... Medtronic (Minneapolis, Minnesota) reported FDA clearance and U.S. commercial release of the Medtronic EnPulse pacing system. The new system incorporates an enhanced suite of features to help physicians better manage patients with slow heart...

MicroMed Technology (Houston, Texas) reported FDA approval of the company's request to supplement its IDE-approved destination therapy clinical trial.(Product Pipeline)
March 1, 2004... MicroMed Technology (Houston, Texas) reported FDA approval of the company's request to supplement its IDE-approved destination therapy clinical trial. The supplement changes the patient randomization scheme to a 2:1 ratio of MicroMed DeBakey...

SS&II.(Product Pipeline)
March 1, 2004... SS&II (Manchester, New Hampshire) reported the allowance of all claims of U.S. patent publication No. 20020151924, covering an angioplasty balloon with ridges mounted on its outer surface for treating occluded coronary and peripheral arteries....

Tepha.(Product Pipeline)
March 1, 2004... Tepha (Cambridge, Massachusetts) reported what it called "a major step forward" in the development of absorbable elastomeric biomaterials for use in cardiovascular stents and other medical devices. The company submitted a device master file to...

Welch Allyn.(Product Pipeline)
March 1, 2004... Welch Allyn (Skaneateles Falls, New York) introduced two new multi-channel electrocardiographs (ECG), the Welch Allyn CP 10 and CP 20. Both units are battery-operated and feature alphanumeric keyboards for easy entry of patient demographics,...

WorldHeart (Oakland, California) reported that the FDA has approved its premarket approval supplement submission to incorporate several engineering enhancements to the implanted and external components of its Novacor left ventricular assist system (LVAS).(Product Pipeline)
March 1, 2004... WorldHeart (Oakland, California) reported that the FDA has approved its premarket approval supplement submission to incorporate several engineering enhancements to the implanted and external components of its Novacor left ventricular assist...

Xtrak Medical.(Product Pipeline)
March 1, 2004... Xtrak Medical (Salem, New Hampshire) reported FDA clearance for its TOPS support catheter. The TOPS operates over standard .014" to .018" steerable guidewires to assist crossing difficult occlusions. Once the occlusion is crossed, TOPS is...

Zoll Medical (Chelmsford, Massachusetts) said that study results show its Rectilinear Biphasic waveform (RBW) improves the resuscitation of out-of-hospital cardiac arrest patients.(Product Pipeline)
March 1, 2004... Zoll Medical (Chelmsford, Massachusetts) said that study results show its Rectilinear Biphasic waveform (RBW) improves the resuscitation of out-of-hospital cardiac arrest patients. The results were presented at the National Association of EMS...