Cardiovascular Device Update articles from August 2004

Cardiovascular Device Update archives from August 2004

Advances in stroke prevention, peripheral vascular therapy.
August 1, 2004... PARIS -- New developments in medical technology are often commercialized in the European market prior to their introduction in the U.S., due to the more rapid regulatory approval process and receptivity of physicians in Europe to new...

ReValving may change valve replacement and open-heart surgery.
August 1, 2004... ReValving--that is, percutaneously implanting a new heart valve over a defective valve instead of cutting it out--has the potential to one day redefine valve replacement surgery, changing it from a very complex surgical procedure to a...

St. Jude becomes third company with entry in U.S. CRT-D market.
August 1, 2004... St. Jude Medical (St. Paul, Minnesota) finally received its invitation from the FDA in late June to the cardiac resynchronization therapy defibrillator (CRTD) party. While the late arrival joined the festivities nearly two years after...

TandemHeart provides short-term alternative to VADs' surgical risks.(ventricular assist device)
August 1, 2004... After drug-eluting stents, the cardiovascular device that has attracted the most headlines and interest over the past two years is probably the ventricular assist device (VAD), a small pump seeing growing use for bridge to heart transplant or...

Nycomed gets cardiac contrast agent rights.(Report from Europe)
August 1, 2004... Acusphere (Watertown, Massachusetts) said last month that it has entered into a collaboration, license and supply agreement with Nycomed (Roskilde, Denmark) for the European development and marketing rights to Acusphere's lead product...

Escalon Medical (Wayne, Pennsylvania) reported that the board of Drew Scientific Group (London) has recommended that its shareholders accept Escalon's revised exchange offer.(Acquisitions)(Brief Article)
August 1, 2004... Escalon Medical (Wayne, Pennsylvania) reported that the board of Drew Scientific Group (London) has recommended that its shareholders accept Escalon's revised exchange offer. Under the previously announced revised proposal, Escalon is offering...

Millenium Holding Group (Henderson, Nevada) has entered into an agreement to merge with Sutura (Fountain Valley, California), a company that develops minimally invasive vessel closure devices.(Acquisitions)(Brief Article)
August 1, 2004... Millenium Holding Group (Henderson, Nevada) has entered into an agreement to merge with Sutura (Fountain Valley, California), a company that develops minimally invasive vessel closure devices to suture the puncture created in the femoral artery...

Sports Information and Publishing (SIPC; Littleton, Colorado) said it has agreed to acquire all of the outstanding shares of Hall Effect Medical Products (Manchester, UK).(Acquisitions)(Brief Article)
August 1, 2004... Sports Information and Publishing (SIPC; Littleton, Colorado) said it has agreed to acquire all of the outstanding shares of Hall Effect Medical Products (Manchester, UK), the owner of two UK-based companies, which are developing a group of...

Boston Sci in broad recall of Taxus DES.(Business Developments)(Boston Scientific )
August 1, 2004... Boston Scientific (Natick, Massachusetts) in mid-July reported a substantially widened recall of its lucrative Taxus paclitaxel-eluting coronary stent. The latest recall expanded an earlier July recall involving about 200 Taxus Express2...

CompuMed (Los Angeles, California), a medical informatics company serving healthcare with diagnostic software solutions, said that it has been awarded a five-year renewal of its contract to provide electrocardiogram (ECG) interpretation systems and services for the New York State Department of Correctional Services (NYDOCS).(Agreements)(Brief Article)
August 1, 2004... CompuMed (Los Angeles, California), a medical informatics company serving healthcare with diagnostic software solutions, said that it has been awarded a five-year renewal of its contract to provide electrocardiogram (ECG) interpretation systems...

Medwave (Danvers, Massachusetts), a developer of sensor-based, non-invasive blood pressure-measuring solutions, and Zoll Medical (Chelmsford, Massachusetts).(Agreements)(Brief Article)
August 1, 2004... Medwave (Danvers, Massachusetts), a developer of sensor-based, non-invasive blood pressure-measuring solutions, and Zoll Medical (Chelmsford, Massachusetts), a maker of non-invasive resuscitation devices and software solutions, reported signing...

Meridian Co. Ltd. (Vancouver, British Columbia) said that its Meridian Medical subsidiary has begun discussions with several partners in the U.S. and Canada for the wholesale distribution rights of two of it's major product lines.(Agreements)(Brief Article)
August 1, 2004... Meridian Co. Ltd. (Vancouver, British Columbia) said that its Meridian Medical subsidiary has begun discussions with several partners in the U.S. and Canada for the wholesale distribution rights of two of it's major product lines. The company...

QMed (Eatontown, New Jersey) said that CHA Health of Kentucky (Lexington, Kentucky) has chosen QMed's diabetes disease management program to manage approximately 5,000 members with this complex condition.(Agreements)(Brief Article)
August 1, 2004... QMed (Eatontown, New Jersey) said that CHA Health of Kentucky (Lexington, Kentucky) has chosen QMed's diabetes disease management program to manage approximately 5,000 members with this complex condition. Implementation is scheduled to begin...

Terumo Cardiovascular Systems (Ann Arbor, Michigan) has signed agreements with Spencer Technologies (Austin, Texas) for global rights to market and distribute Spencer's current offering of diagnostic ultrasound products for cardiology and neurology applications and future products co-developed by the two companies.(Agreements)(Brief Article)
August 1, 2004... Terumo Cardiovascular Systems (Ann Arbor, Michigan) has signed agreements with Spencer Technologies (Austin, Texas) for global rights to market and distribute Spencer's current offering of diagnostic ultrasound products for cardiology and...

'Acting' tag removed for CDRH's Schultz.(Market Updates)(Center for Devices and Radiological Health )(Daniel Schultz)
August 1, 2004... Daniel Schultz, MD, acting director of the FDA's Center for Devices and Radiological Health (CDRH) since April, last month had the "acting" term removed from his title by acting FDA Commissioner Lester Crawford. In announcing the appointment of...

CMS looks at TMR, PMR.(transmyocardial revascularization)(percutaneous myocardial revascularization)
August 1, 2004... Proactive and not reactive. That seemed to be the effort the Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) was undertaking when it convened a meeting of its Medicare Coverage Advisory Committee (MCAC) last month. The...

Closing gap in healthcare practice, research.(Market Updates)
August 1, 2004... Healthcare researchers, academics and clinicians gathered at the Washington Convention Center last month for a three-day conference focusing on bringing healthcare discovery into everyday practice. A presentation on research-based quality...

Abiomed.(Personnel File)(Brief Article)
August 1, 2004... Abiomed (Danvers, Massachusetts) has appointed Karim Benali, MD, vice president of product development and Vincent Wong director of commercial soft, ware engineering. Benali previously held several global positions in R&D, product management...

CardioGenesis.(Personnel File)(Brief Article)
August 1, 2004... Joseph Kletzel II has been named senior vice president and general manager of the Pacific Division of CardioGenesis (Foothill Ranch, California). Kletzel has more than 25 years of operations and strategic management experience with biotech and...

CryoCar.(Personnel File)(Brief Article)
August 1, 2004... K Kay Hannah has joined CryoCor (San Diego, California) in the newly created position of vice president, human resources. Hannah has more than 12 years of human resources experience with start-up companies, such as SonoSite, where she served as...

HemoSense.(Personnel File)(Medical equipment industry)(Brief Article)
August 1, 2004... Timothy Still has been named executive Vice president of sales and marketing at HemoSense (San Jose, California). He previously was vice president of sales and marketing for Cholestech. HemoSense's products include the INRatio System, which...

OmniSonics Medical Technologies.(Personnel File)(Brief Article)
August 1, 2004... Anne Kulis has been named vice president of quality, regulatory and clinical affairs for OmniSonics Medical Technologies (Wilmington. Massachusetts), a developer of advanced medical devices to treat vascular occlusive disease. Most recently,...

SynCardia Systems.(Personnel File)(Brief Article)
August 1, 2004... Sam Williams has been named chief financial officer for SynCardia Systems (Tucson, Arizona). He previously was chief financial officer at AlphaGraphics. SynCardia Systems develops biomechanical cardiac replacement and assist devices. Its...

Trial may REVERSE fortunes in CHF.(REsynchronization reVErses Remodeling in Systolic left vEntricular)
August 1, 2004... The number of patients who could benefit from cardiac resynchronization therapy (CRT) with and without defibrillator backup could dramatically increase if results of a new worldwide clinical trial sponsored by Medtronic (Minneapolis, Minnesota)...

AccessClosure.(Product Pipeline)(wound-healing hydrogel )(Brief Article)
August 1, 2004... * AccessClosure (Mountain View, California) reported completion of enrollment in the pivotal U.S. clinical investigation designed to evaluate the safety and efficacy of the Matrix VSG System, a synthetic wound-healing hydrogel designed to seal...

Biosite.(Product Pipeline)(point-of-care panel )(Brief Article)
August 1, 2004... * Biosite (San Diego, California) has devised a new point-of-care panel that will be used to aid in the diagnosis of patients who present at emergency departments with shortness of breath, with the company saying that more than 10 million...

Boston Scientific.(Product Pipeline)(Brief Article)
August 1, 2004... * Boston Scientific (Natick, Massachusetts) reported the worldwide launch of its Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch for vascular or cardiac patch grafting. The company said the Hemashield Platinum Finesse patch...

Cardiac Science.(product approval)(Brief Article)
August 1, 2004... * Cardiac Science (Irvine, California) received FDA 510(k) clearance to market its new Powerheart G3-Automatic automated external defibrillator (AED), calling it "the first fully-automatic AED in the Powerheart product line." The new-generation...

Cook.(fenestrated endovascular graft got licensing )(Brief Article)
August 1, 2004... * Cook (Bloomington, Indiana) reported receiving the first clearance in the U.S. to begin investigational use of a fenestrated endovascular graft for complex abdominal aortic aneurysms (AAAs). The FDA approved investigational use of its Zenith...

Corautus Genetics (Atlanta, Georgia) reported that the FDA has approved the start of its Phase IIB clinical trial for the treatment of severe cardiovascular disease.(Product Pipeline)(Brief Article)
August 1, 2004... * Corautus Genetics (Atlanta, Georgia) reported that the FDA has approved the start of its Phase IIB clinical trial for the treatment of severe cardiovascular disease. The trial will be a national, randomized, double-blinded, dose ranging and...

Creative Clinical Concepts.(Product Pipeline)(Brief Article)
August 1, 2004... * Creative Clinical Concepts (Denver, Colorado) said an aspirin resistance test from its AspirinWorks subsidiary is now available nationwide. The test, also known as AspirinWorks, is suited for patients on long-term aspirin therapy and can be...

CryoCor.(Product Pipeline)(Brief Article)
August 1, 2004... * CryoCor (San Diego, California) has received conditional approval to begin a U.S. pivotal clinical study to treat paroxysmal atrial fibrillation under an investigational device exemption granted by the FDA. The purpose of the pivotal study is...

Devax.(Product Pipeline)(Brief Article)
August 1, 2004... * Devax (Irvine, California) reported the initiation of the Axxess Plus Clinical Study for the company's Axxess Drug-Coated Stent System. The Axxess system is the first bifurcated stent design to elute an anti-restenonic drug. The study is a...

Epix Medical.(Product Pipeline)(Brief Article)
August 1, 2004... * Epix Medical (Cambridge, Massachusetts) reported initiation of its post-new drug application clinical program with the first injection in a multi-center trial of MS-325 for high-resolution vessel imaging. MS-325 is a magnetic resonance...

GE Healthcare.(Product Pipeline)(Brief Article)
August 1, 2004... * GE Healthcare (Waukesha, Wisconsin) reported the commercial introduction of the LightSpeed VCT, or volume CT (computed tomography), which one product manager called "the beginning of the volume CT generation of CT scanners." The new device...

The FDA has cleared for marketing Intuitive Surgical's (Sunnyvale, California) da Vinci surgical system to assist in coronary artery bypass surgery in which there is direct access to the chest using standard open chest technique (sternotomy) or a smaller surgical incision (thoracotomy).(Product Pipeline)
August 1, 2004... * The FDA has cleared for marketing Intuitive Surgical's (Sunnyvale, California) da Vinci surgical system to assist in coronary artery bypass surgery in which there is direct access to the chest using standard open chest technique (sternotomy)...

Lifestream Technologies.(Product Pipeline)(Brief Article)
August 1, 2004... * Lifestream Technologies (Post Falls, Idaho), a manufacturer of home cholesterol monitors and professional screening devices, said the results of an independent accuracy and precision study showed that the Lifestream Cholesterol Monitor's...

Medtronic.(Product Pipeline)(Brief Article)
August 1, 2004... * Medtronic (Minneapolis, Minnesota) reported FDA approval and the commercial release of the InSync Maximo cardiac resynchronization therapy defibrillator system. With 35 joules of delivered energy and the industry's fastest charge times,...

Medtronic Vascular.(Product Pipeline)(Interceptor PLUS Carotid Filter System)(Brief Article)
August 1, 2004... * Medtronic Vascular (Santa Rosa, California) received the CE mark for its Interceptor PLUS Carotid Filter System. The Interceptor PLUS system can be used in combination with the Exponent Carotid Stent from Medtronic or other approved carotid...

MIV Therapeutics (Vancouver, British Columbia) reported completing the full range of biocompatibility studies on its biocompatible hydroxyapatite (HAp) ultra-thin coating technology.(Product Pipeline)(Brief Article)
August 1, 2004... * MIV Therapeutics (Vancouver, British Columbia) reported completing the full range of biocompatibility studies on its biocompatible hydroxyapatite (HAp) ultra-thin coating technology. The coating is designated for passive and drug-eluting...

Recom Managed Systems.(Product Pipeline)(Brief Article)
August 1, 2004... * Recom Managed Systems (Los Angeles, California) said it would be undertaking a user preference study under the supervision of a third-party institutional review board to test the company's first-generation ambulatory ECG device against...

Siemens Medical Solutions.(Product Pipeline)(digital C-arm imaging system)(Brief Article)
August 1, 2004... * Siemens Medical Solutions' (Malvern, Pennsylvania) Angiography and X-ray Division said it has received FDA marketing clearance for the Axiom Artis U, a moveable, digital C-arm imaging system. The system, which offers four times more generator...

St. Jude Medical (St. Paul, Minnesota) reported the first North American implant and Canadian regulatory approval of its SJM Epic Supra valve.(Product Pipeline)(Brief Article)
August 1, 2004... * St. Jude Medical (St. Paul, Minnesota) reported the first North American implant and Canadian regulatory approval of its SJM Epic Supra valve. The implant was performed by Robert Cossette, MD, chief of cardiac surgery at Sacre-Coeur Hospital...

Sub-Q.(Product Pipeline)(SureStat Arterial Closure System)(Brief Article)
August 1, 2004... * Sub-Q (San Clemente, California) received FDA approval for its SureStat Arterial Closure System. SureStat is the next generation of closure technology approved in the U.S. for the extravascular, or outside the vessel, closure of femoral...

ThermoGenesis.(Product Pipeline)(BioArchive System )(Brief Article)
August 1, 2004... * ThermoGenesis (Rancho Cordova, California) has received notice from the U.S. Patent and Trademark Office of the issuance of the third in a series of patents describing a 3-D, compartmentalized bag configured to provide cryopreservation for...

Zoll Medical.(Product Pipeline)( Lifecor Life-Padz WCD 3000S System)(Brief Article)
August 1, 2004... * Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and software solutions, said that the FDA has granted marketing clearance for the Lifecor Life-Padz WCD 3000S System, a next-generation, wearable cardioverter...