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April 23, 2009

Vascular Closure Devices at the Crossroads

Article preview reprinted Medtech Insight - April, 2009 

Find out how the rapid proliferation of catheter-based interventional devices and procedures over the past two decades has revolutionized the diagnosis and treatment of coronary and peripheral vascular disease, enabling physicians to gain access to diseased vessels using only an introducer needle, guidewire, and catheter.

Vascular Closure Devices at the Crossroads

Article preview reprinted Medtech Insight - April, 2009 

The success of these techniques has spawned a movement to bring other procedures under the interventional umbrella, which over the past several years has expanded to encompass abdominal and thoracic aortic aneurysms, blockages in the carotid and cerebral arteries, and most recently, the rapidly evolving fields of atrial fibrillation (AF) ablation and heart valve replacement and repair.

All told, there are some 15 million procedures performed worldwide each year using interventional, catheter-based techniques, and this number is expanding yearly as aging populations demand less invasive treatments and advances in the technologies themselves extend transcatheter therapies to a wider range of patients. This revolution in patient care has generated multibillion dollar product markets for the wires, catheters, and other devices used to perform these procedures; but there is another huge device opportunity out there—one that is often overlooked. This opportunity addresses an essential part of each and every transcatheter procedure: hemostasis at the site of the vascular puncture, the hole that is made in an artery or vein to allow passage of the catheter and devices into the vasculature.

Lingering Concerns and Misconceptions

For every percutaneous procedure performed, there is a puncture site that needs to be addressed. These punctures are typically made in vessels associated with high-pressure blood flow and must be stabilized or they will continue to bleed. But given the advanced delivery systems and other devices now available to enable transcatheter procedures, the most common way of achieving puncture site hemostasis—applying manual pressure to the site—seems comparatively archaic. In fact, manual compression has been around since catheter-based procedures were first devised in the 1950s. And although it does the job, it is far from ideal. Manual compression is time consuming, resource intensive, and uncomfortable for patients, who must lie still with a weight on their groin for six to eighteen hours following their procedure.

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Companies mentioned in this article:

Abbott Laboratories Inc.

AccessClosure Inc.

Brigham and Women's Hospital

CardioDex Ltd.

Cardiva Medical Inc.

Cook Group Inc.

Cook Biotech Inc.

Covidien Ltd.

Confluent Surgical Inc.

Getinge AB

Datascope Corp.

Johnson & Johnson

Cordis Corp.

Ensure Medical Inc.

Kensey Nash Corp.

Morris Innovative Research Inc.

Sadra Medical Inc.

St. Jude Medical Inc.

Radi Medical Systems

Vascular Closure Systems Inc.

Vasorum Ltd.

Medtech Insight delivers the quality content you need on medical technologies impacting the spectrum of surgical, orthopedic, cardiovascular, and other markets. Written and edited by seasoned industry participants and experts, the Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices (cardiothoracic & vascular surgery, general surgery, orthopedics & spine surgery, interventional radiology/cardiology, etc.). Learn more at www.medtechinsight.com.

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