Cardiovascular Device Update articles from December 2004

Cardiovascular Device Update archives from December 2004

Device-based therapies expand role in heart disease management.
December 1, 2004... NEW ORLEANS -- The management of heart disease has undergone a dramatic evolution over the past 20 years, driven by major developments in devices used for the treatment of vascular conditions and arrhythmia. As a result of the implementation of...

Cardio innovation in the clinical setting is explored at conference.
December 1, 2004... CLEVELAND -- Eric Topol, MD, chief academic officer of the Cleveland Clinic, said during the Clinic-sponsored Medical Innovation Summit here in mid-October that those involved with or interested in innovation need to get away from the idea that...

Cosgrove: innovation, speed determining future of medicine.
December 1, 2004... What precisely does innovation mean in the context of healthcare? Delos "Toby" Cosgrove, MD, the newly appointed president and CEO of the Cleveland Clinic, addressed that question in his opening remarks at this year's Clinic-sponsored Medical...

At the edge of Europe, Ireland becomes a center of med-tech.
December 1, 2004... GALWAY, Ireland -- In late September, the fourth annual MedTec Ireland conference and trade show was held in the small but buzzing Irish city of Galway, sponsored by Canon Communications. This is one of the westernmost cities in Europe; in...

Report cites gains in NHS emergency care.(Report from Europe)(National Health Service)
December 1, 2004... Sir George Alberti, head of emergency care for the UK's National Health Service (NHS), said that improvements in this area over the past two years have transformed its emergency care performance so that "it is now the envy of the world."...

E-Z-EM (Lake Success, New York) reported that the spin-off of its AngioDynamics subsidiary has been completed.(Acquisitions)(Brief Article)
December 1, 2004... E-Z-EM (Lake Success, New York) reported that the spin-off of its AngioDynamics subsidiary has been completed. On Oct. 30, E-Z-EM distributed 0.856377 of a share of AngioDynamics common stock as a dividend on each outstanding share of E-Z-EM...

Medtronic Vascular (Santa Rosa, California) reported that it has acquired Angiolink (Taunton, Massachusetts), a privately held medical device company focused on developing wound closure solutions for vascular procedures.(Acquisitions)(Brief Article)
December 1, 2004... Medtronic Vascular (Santa Rosa, California) reported that it has acquired Angiolink (Taunton, Massachusetts), a privately held medical device company focused on developing wound closure solutions for vascular procedures. Angiolink's EVS...

Biosensors' BioMatrix a non-polymer DES.(Business Developments)
December 1, 2004... Thus far, the two drug-eluting stent (DES) products commercialized in the U.S. utilize a polymer as a method of incorporating drug and device. But the first-generation use of polymers may not be a model for future DES technologies, according to...

Angiotech Pharmaceuticals (Vancouver, British Columbia) reported that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act (HSR) has expired pertaining to the proposed grant of an exclusive license to Boston Scientific (Natick, Massachusetts) with respect to the use of paclitaxel and other agents on medical devices in the coronary vascular field of use.(Agreements)(Brief Article)
December 1, 2004... Angiotech Pharmaceuticals (Vancouver, British Columbia) reported that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act (HSR) has expired pertaining to the proposed grant of an exclusive license to Boston Scientific...

Cardiac Science (Irvine, California), a maker of automated external defibrillators (AEDs), said it has entered into a distribution arrangement with Hagemeyer North America (HNA; Charleston, South Carolina).(Agreements)(Brief Article)
December 1, 2004... Cardiac Science (Irvine, California), a maker of automated external defibrillators (AEDs), said it has entered into a distribution arrangement with Hagemeyer North America (HNA; Charleston, South Carolina). Under the agreement, Cardiac Science...

CryoCath Technologies (Montreal), which calls itself the global leader in cryotherapy products to treat cardiovascular disease.(Agreements)(Brief Article)
December 1, 2004... CryoCath Technologies (Montreal), which calls itself the global leader in cryotherapy products to treat cardiovascular disease, said it has agreed to terms on a partnership that grants ATS Medical (Minneapolis) co-promotion rights in the U.S....

Fischer Imaging (Denver) said it has signed an agreement with Virtual Imaging (Delray Beach, Florida) to supply components to be incorporated into a digital X-ray system designed for trauma and general radiographic use.(Agreements)(Brief Article)
December 1, 2004... Fischer Imaging (Denver) said it has signed an agreement with Virtual Imaging (Delray Beach, Florida) to supply components to be incorporated into a digital X-ray system designed for trauma and general radiographic use. Fischer will sell U-arm...

In Vivo Medical Diagnostics (IVMD; Inverness, Scotland) said that the company is supporting Inverness Medical Innovations (Waltham, Massachusetts), a manufacturer and marketer of rapid diagnostic products for the professional and consumer markets, in its development of a Prothrombin Time monitor for use in U.S. clinical trials.(Agreements)(Brief Article)
December 1, 2004... In Vivo Medical Diagnostics (IVMD; Inverness, Scotland) said that the company is supporting Inverness Medical Innovations (Waltham, Massachusetts), a manufacturer and marketer of rapid diagnostic products for the professional and consumer...

Wilson Greatbatch Technologies (WGT; Clarence, New York) reported signing an agreement with St. Jude Medical (St. Paul, Minnesota) to extend the terms of their current supplier partnering agreement through the end of 2008.(Agreements)(Brief Article)
December 1, 2004... Wilson Greatbatch Technologies (WGT; Clarence, New York) reported signing an agreement with St. Jude Medical (St. Paul, Minnesota) to extend the terms of their current supplier partnering agreement through the end of 2008. The current...

Does race-based drug point to new ground?(Market Updates)
December 1, 2004... The annual scientific sessions of the American Heart Association (AHA; Dallas) primarily feature broad platforms for new product rollouts, an avalanche of clinical trials and even, occasionally, some interesting debate. And this year's edition...

Arrow International.(Personnel File)(Philip Fleck)(Frederick Hirt)(Brief Article)
December 1, 2004... Arrow International (Reading, Pennsylvania) reported the promotion of several executives to positions of new responsibility and the retirement of Philip Fleck, president and chief operating officer, effective Dec. 31. Fleck has a total of 33...

Bioheart.(Personnel File)(Brief Article)
December 1, 2004... Bioheart (Weston, Florida) recently more than tripled the size of its R&D facility and reported several additions to its research staff. Richard Spencer has joined the company as vice president, clinical affairs and physician relations. He...

CryoLife.(Personnel File)(D. Ashley Lee )(Brief Article)
December 1, 2004... CryoLife (Kennesaw, Georgia) has promoted D. Ashley Lee from vice president of finance, treasurer and CFO to executive vice president, treasurer and CFO. Lee joined the company as controller in 1994. CryoLife processes and distributes...

CryoCath gets FDA nod for Freezor MAX.(Product Pipeline)
December 1, 2004... CryoCath Technologies (Montreal), a company developing cryotherapy products to treat cardiovascular disease, reported that its Freezor MAX catheter has received a supplemental premarket approval (PMA) indication from the FDA, allowing it to...

Abbott Laboratories.(Product Pipeline)(Brief Article)
December 1, 2004... * The diagnostics division of Abbott Laboratories (Abbott Park, Illinois) has expanded the product offering for its AxSYM automated immunoassay system with an updated test for the detection of cardiac troponin. The company is now ready to...

Boston Scientific.(Product Pipeline)(Brief Article)
December 1, 2004... * Boston Scientific (Natick, Massachusetts) reported the start of enrollment in the ARRIVE 2 registry program, which plans to enroll 5,000 patients at about 60 centers in the U.S. The program is designed to collect and analyze "real world"...

CryoCor.(Product Pipeline)(Brief Article)
December 1, 2004... * CryoCor (San Diego) reported receiving FDA 510(k) clearance for the Breva Surgical Probe, part of its Cardiac Cryoablation System, which includes a control console and a probe/console interface. The Breva Surgical Probe is intended to be used...

Endologix.(Product Pipeline)(Brief Article)
December 1, 2004... * Endologix (Irvine, California) reported that it has received a conditional approval letter from the FDA, allowing it to commercially distribute the Powerlink system, an endoluminal stent graft (ELG) for the minimally invasive treatment of...

Endomed.(Product Pipeline)(Brief Article)
December 1, 2004... * Endomed (Phoenix) reported the market release of its AccuSet introducer catheter for the delivery of EndoFit Aortic Endovascular Grafts. The AccuSet catheter allows for precision positioning and control during endograft deployment. The...

ev3.(Product Pipeline)(Brief Article)
December 1, 2004... * ev3 (Plymouth, Minnesota) has received 510(k) clearance from the FDA for the use of the company's Protege GPS Nitinol Self-Expanding Long Stents to treat malignant biliary strictures. The stents are used during a minimally invasive procedure...

Guidant (Indianapolis) said it has begun enrollment in CAPTURE (Carotid Acculink/Accunet Post Approval Trial to Uncover Rare Events), an FDA-required post-approval study of carotid artery stenting performed by physicians from multiple specialties.(Product Pipeline)(Brief Article)
December 1, 2004... * Guidant (Indianapolis) said it has begun enrollment in CAPTURE (Carotid Acculink/Accunet Post Approval Trial to Uncover Rare Events), an FDA-required post-approval study of carotid artery stenting performed by physicians from multiple...

Kensey Nash.(Product Pipeline)(Brief Article)
December 1, 2004... * Kensey Nash (Exton, Pennsylvania) said it has received a comment letter from the FDA related to its application for 510(k) clearance for its TriActiv System. The company said it is preparing its response to the letter and intends to file a...

Medtronic.(Product Pipeline)
December 1, 2004... * A new clinical study reported the journal Circulation shows that patients with mild heart failure may benefit from cardiac resynchronization therapy (CRT) in much the same way that those with moderate or severe heart failure do, which could...

Medtronic Vascular (Santa Rosa, California) reported that the first patient was enrolled in the MAVErIC III Clinical Trial, the third in a series of studies to evaluate a system of devices to treat blockages in the carotid arteries that can lead to ischemic strokes.(Product Pipeline)(Brief Article)
December 1, 2004... * Medtronic Vascular (Santa Rosa, California) reported that the first patient was enrolled in the MAVErIC III Clinical Trial, the third in a series of studies to evaluate a system of devices to treat blockages in the carotid arteries that can...

Quinton Cardiology Systems.(Product Pipeline)(Brief Article)
December 1, 2004... * Quinton Cardiology Systems (Bothell, Washington) has started shipping the Q-Stress version 3.5 cardiac stress testing system. The company said its latest software version delivers substantial clinical and ease-of-use advantages, while...

Recom Managed Systems.(Product Pipeline)(Brief Article)
December 1, 2004... * Recom Managed Systems (Studio City, California) reported that its Model 100 ambulatory electrocardiograph diagnostic device now meets the applicable requirements of the FDA-recognized voluntary consensus standards for ambulatory...

Synthetic Blood International (Costa Mesa, California) said a report of an Oxycyte study in a rat stroke model has been accepted for publication in Neurological Research.(Product Pipeline)(Brief Article)
December 1, 2004... * Synthetic Blood International (Costa Mesa, California) said a report of an Oxycyte study in a rat stroke model has been accepted for publication in Neurological Research. The report, "Early Administration of a Second-Generation...

Thoratec (Pleasanton, California) reported that Everardo Flores has become the first patient ever to log 365 days of support on the HeartMate II left ventricular assist system (LVAS), its next-generation heart assist device designed to provide long-term cardiac support for patients with end-stage heart failure.(Product Pipeline)(Brief Article)
December 1, 2004... * Thoratec (Pleasanton, California) reported that Everardo Flores has become the first patient ever to log 365 days of support on the HeartMate II left ventricular assist system (LVAS), its next-generation heart assist device designed to...

Trimedyne.(Product Pipeline)(Brief Article)
December 1, 2004... * Trimedyne (Irvine, California) said the U.S. Patent and Trademark Office has allowed its patent application on a new laser angioplasty device. The patent covers optical fiber devices designed to make smooth channels through plaque deposits in...

Vasomedical (Westbury, New York) reported that Phase 2 of the International EECP Patient Registry (IEPR-2) has met its enrollment target of 2,500 patients.(Product Pipeline)(Brief Article)
December 1, 2004... * Vasomedical (Westbury, New York) reported that Phase 2 of the International EECP Patient Registry (IEPR-2) has met its enrollment target of 2,500 patients. IEPR-2 collects additional data to better characterize angina patients with coexisting...

Ventracor (Sydney, Australia) reported that St. Vincent's Hospital (also Sydney) had performed two implants of its VentrAssist "artificial heart" as part of a global trial to gain European approval.(Product Pipeline)(Brief Article)
December 1, 2004... * Ventracor (Sydney, Australia) reported that St. Vincent's Hospital (also Sydney) had performed two implants of its VentrAssist "artificial heart" as part of a global trial to gain European approval. The company said five implants have now...