Medical Device Daily Contributing Writer

NEW YORK – Numerous companies from across the device/drugs/diagnostics spectrum presented during BMO Capital Markets' 2008 Focus on Healthcare Conference at the Millennium Broadway hotel last week, with one of the areas of emphasis being atrial fibrillation (AF).

AF is the most common form of chronic heart arrhythmia seen in clinical practice. It causes the heart's upper chamber (atria) to quiver, or fibrillate, rapidly instead of beating in a normal pattern. AF also is associated with more serious and life-threatening disorders such as embolic stroke, which is three to five times more likely in AF patients than in those not suffering from it.

Drugs for controlling the rapid ventricular rate associated with AF are the first line of therapy, but fail to work in an estimated 40% to 50% of patients.

Ablation catheters are used to create lesions in cardiac tissue to block the abnormal electrical impulses that cause AF. It is a minimally invasive interventional procedure and should be distinguished from surgical ablation which is typically performed as concomitant to another open health procedure such as repair or replacement of a heart valve or coronary artery bypass surgery.

Interventional cardiologists and electrophysiologists perform off-label ablation catheter procedures to treat AF. To date, the FDA has not cleared any devices specifically for the treatment of AF. The first ablation catheter to receive FDA clearance for treating AF is expected to be from Biosense Webster (Diamond Bar, California), a subsidiary of Johnson & Johnson (New Brunswick, New Jersey).

AtriCure (West Chester, Ohio) markets a range of products for treating AF, either concomitant with an open-heart surgical procedure or in a sole therapy minimally invasive procedure. Its Isolator bipolar ablation system has FDA clearance for soft-tissue indications in thoracic and general surgical procedures and is used during open-heart surgery to create lesions in cardiac tissue to block the abnormal electrical impulses that cause AF. It has been used in more than 50,000 procedures at some 700 medical centers.

The Isolator system comprises a compact automated power generator, clamps that use bipolar radio frequency (RF) energy to create transmural lesions and a multifunctional pen designed for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias.

Earlier this year, the company introduced the Coolrail linear ablation pen that is used with the bipolar ablation clamps to replicate the Cox-Maze surgical procedure through a minimally invasive sole-therapy approach. President/CEO David Drachman presented the company's 15-month plan for new product launches, which includes a disposable cryogenic probe, a second-generation Coolrail device with expanded features, multielectrode thoracoscopic clamp, and a left atrial appendage clip.

CryoCath Technologies (Kirkland, Quebec) makes cryoablation therapies for AF, both catheter-based and open surgery-based. Its ArticFront cryoballoon has the CE mark and is sold in Europe.

The company is conducting the STOP AF pivotal investigational device exemption randomized trial with an enrollment of 270 patients with paroxysmal AF. The primary endpoint is freedom from detectable AF after12 months.

The Arctic Front catheter is delivered to the left atrium via the FlexiCath steerable sheath. The two-hour procedure consists of wiring the target vein with a 0.035" compatible guide wire. The catheter is deployed in the left atrium and inflated before being advanced toward the wired vein. There is no need for 3-D mapping.

More than 3,100 patients have been treated with the ArticFront cryoballoon. The company expects to obtain PMA approval from the FDA by the end of 2009.

CryoCath's products include the Freezor family of cryocatheters that are designed to create focal lesions to treat atrioventricular reentry tachycardia and the CryoConsole, a microprocessor-based electromechanical refrigeration unit which processes refrigerant to create cryogenic temperatures.

Privately held Estech (San Ramon, California) markets a diverse line of minimal access instruments to cardiothoracic surgeons. These products are for cardiac ablation, coronary bypass, valve repair and replacement, and heart failure surgery.

The company's focus is on developing medical devices that enable the least invasive cardiovascular surgical procedures, but not catheter ablation products. Its Cobra surgical system is a multiple-electrode, temperature-controlled RF ablation system for the treatment of AF. It uses precisely controlled RF energy to create reproducible and uniform transmural lesions during cardiac surgery.

Estech says surgical AF outcomes and complication rates are superior to catheter-based technologies and the sector will have a 40% annual growth rate through 2011.

BioSphere Medical (Rockland, Massachusetts) is the leading marketer of microspheres used in embolotherapy procedures to reduce blood flow to targeted tissues in order to achieve a therapeutic benefit. Its products include Embosphere microspheres for treating uterine fibroids, hyper-vascularized tumors and other arteriovenous malformations.

HepaSphere microspheres are used to treat primary and metastatic liver cancer. The microspheres are precisely calibrated, spherical, hydrophilic, micro-porous beads made of an acrylic co-polymer (trisacryl) which is then cross-linked with gelatin. This patented design allows a more complete and targeted occlusion of the blood vessels feeding a hyper-vascularized tumor or arteriovenous malformation.

The hydrophilic surface and spherical shape prevent aggregation within the catheter lumen and in the vasculature, promoting ease and accuracy of delivery. The elastic properties of the microspheres allows for their temporary deformation which facilitates their passage through small delivery systems.

Vision Sciences (Orangeburg, New York) manufactures advanced flexible endoscopy products. Its EndoSheath system includes a digital videoscope and a sterile single-use sheath that slides over the insertion tube of the endoscope for quick and efficient endoscope turnover while ensuring a sterile procedure.

The company aims to establish its sheath as a standard of care for "small insertion tube" endoscopy such as bronchoscopy, cystoscopy, trans-nasal esophagoscopy and ENT. The combination of its scopes and sheaths result in a unique "open architecture" endoscopy. Its sheaths come in several configurations and channel sizes, thus allowing the physician to configure and customize the scope for the specific procedure.

The absence of a channel in its scopes (the channel is part of the single-use sheath) overcomes the common and expensive problem of breakage that occurs with other endoscopes. The company also has eliminated the need for an external light source, and has integrated inside the scope a high intensity LED-based light source that lasts for more than 50,000 hours and has a life-time warranty from the company.

In June, the company signed a manufacturing and supply agreement with SpineView (Fremont, California) for its CCD-based video endoscopy platform to be used in certain minimally invasive spine surgery procedures. Medtronic (Minneapolis) is licensed to manufacture Vision Sciences' ENT sheaths and to distribute its scopes to ENT markets worldwide.

Bio-Imaging Technologies (Newtown, Pennsylvania) is a clinical research organization that serves the pharmaceutical, biotechnology and medical device industries by managing clinical data in which there is an imaging component. Conducting trials for medical devices is a small but growing portion of its overall business, with those trials thus far for musculoskeletal and cardiovascular products.

The company has completed six acquisitions in the 2001-2008 period and has operations in Leiden, the Netherlands, and Lyon, France. In March, Bio-Imaging Technologies acquired Phoenix Data Systems (King of Prussia, Pennsylvania), a leading company in electronic data capture and data management, in a cash-and-stock transaction totaling $24 million.

This was its largest acquisition and added 37% to its staff, which now totals about 450 employees. It also expands the range in the stage of drug development at which the company's services have been typically rendered from Phase I to Phase III. To date, Bio-Imaging Technologies has been involved in 800 clinical trials on behalf of 150 clients.

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