Clinical and Industry News

Bayer Launches JETSTREAM Navitus L Atherectomy Catheter

Bayer HealthCare has introduced the JETSTREAM Navitus L Atherectomy Catheter. Positioned as the largest diameter rotational atherectomy device in the JETSTREAM catheter family, the Navitus L catheter can create a lumen 30% larger than the standard Navitus device. Intended to treat above-the-knee PAD, the Navitus L can be used in multiple lesions morphologies, including calcium and thrombus while providing differential cutting, to remove the lesion materials while preserving the soft vessel walls. Like all JETSTREAM Atherectomy catheters, the Navitus L provides continuous, active aspiration and the unique front-facing cutting head. Like the original Navitus, the Navitus L offers two-stage cutting with expandable blade technology allowing physicians to treat both CFA and SFA disease with a single catheter.

CardiAQ’s Nonsurgical Bioprosthetic Mitral Heart Valve Successfully Implanted

Nearly 50% of patients suffering from a diseased mitral heart valve with severe, symptomatic regurgitation are denied open-heart surgery because it is considered too risky; in the future, transcatheter mitral valve implantation may offer new hope for these patients.

CardiAQ Valve Technologies, which has developed a self-conforming and self-anchoring technology for nonsurgical transcatheter mitral valve implantation (TMVI), announced that a bioprosthetic mitral heart valve was successfully implanted as a compassionate treatment into an 86-year-old male suffering from severe mitral regurgitation (MR 4+). The breakthrough TMVI procedure was performed on June 12, 2012, at The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark, by interventional cardiologists Lars Søndergaard, MD, and Olaf Franzen, MD, cardiovascular surgeon Susanne Holme, MD, anesthesiologist Peter Bo Hansen, MD, and echocardiographer Nikolaj Ihlemann, MD.

“Our TMVI system is designed to make nonsurgical mitral heart valve replacement a future alternative to open-heart surgical replacement and repair,” said Rob Michiels, CEO of CardiAQ Valve Technologies. “While several companies have been trying to perfect a percutaneous approach to repair the mitral valve, we believe that such technologies will have a very difficult time demonstrating sufficient efficacy in treating such a heterogeneous disease,” added Michiels. “CardiAQ’s nonsurgical valve implantation approach is designed to become a disruptive technology with a much broader application.”

“CardiAQ has focused on replacement or implantation-not repair-for three reasons: Replacement of the diseased mitral valve offers (1) the best chance of eliminating regurgitation, (2) the widest applicability across patient and disease variations, and (3) can be made into a simple, fast, straightforward interventional, i.e., nonsurgical, procedure,” said Brent Ratz, co-founder and COO.

“As cardiac surgeons, we are taught that residual mitral regurgitation will only lead to more mitral regurgitation and progressive symptoms. That is why we have focused our efforts on developing a replacement technology with the potential to eliminate clinically significant MR, not just reduce it,” said Arshad Quadri, MD, chairman, founder/inventor and CMO of CardiAQ. “Moreover, many of these inoperable patients suffer from functionalMR, which is actually a result of ventricular dilatation. CardiAQ’s chordal-sparing approach, combined with its unique anchoring system, provides what can best be described as a ‘face-lift for the heart’ that may also help promote positive remodeling of the ventricle.”

Caution: The CardiAQ^™ Valve Technologies System is not available in the USA for clinical trials until further notice and is NOT available for sale.

Bayer Launches Medrad Mark 7 Arterion^® Injection System

Bayer HealthCare’s Radiology and Interventional unit has launched the new Mark 7 Arterion^® Injection System, the latest in the Medrad Mark series of angiographic injectors. The first Medrad Mark injector was introduced for use in angiograms more than 40 years ago.

“The Mark 7 Arterion system’s user interface facilitates the setting up and performing of contrast injections,” said Robyn Reising, of Decatur Memorial Hospital where the very first Arterion system was installed in the U.S. “The front-load system streamlines the pre and post-procedure activities and the clear syringe allows us to monitor the purging of air.”

In 1964, the first Medrad injector – called the Heilman-Wholey Injector – was the first flow-controlled angiographic injector commercialized in the U.S. The Arterion is the  7th in the Mark series for angiography.

Find more information at www.bayerhealthcare.com.