Clinical and Industry News

Compiled by Cath Lab Digest

Compiled by Cath Lab Digest

AngioDynamics to Acquire Navilyst Medical for $372 Million

AngioDynamics, a provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced it has entered into a definitive agreement to acquire privately-held Navilyst Medical in a transaction valued at $372 million based on the January 30th closing stock price of $14.20.

Navilyst Medical is a global medical device company involved in the vascular access, interventional radiology and interventional cardiology markets. Avista Capital Partners acquired the business from Boston Scientific in 2008, and it generated sales of $149 million in calendar 2011. The acquisition will significantly expand AngioDynamics’ scale, doubling its share of the vascular access market while building critical mass in the peripheral vascular market. The transaction will be accretive to net sales growth, EBITDA margin and earnings per share.

Technology

  • BioFlo® products utilize a novel technology that minimizes the accumulation of thrombus in vascular products such as PICCs, ports and dialysis catheters. BioFlo PICC is approved for use in Canada and Europe and is pending U.S. FDA 510(k) market clearance.
  • Patented Pasv® 3-way valve technology has a long clinical history in ports and PICCs and is designed to automatically resist backflow.
  • Namic has been the gold standard in fluid management in the cardiology catheter lab and interventional radiology office setting for more than 40 years.
  • Automated power injector in development has potential for significant reductions in contrast usage and radiation exposure.

Product Portfolio. The combined companies’ vascular access business will offer a full line of ports, PICCs and other products differentiated by advanced technologies like the Pasv valve and BioFlo from Navilyst, and Smart Port® power-injectable ports featuring Vortex® port technology from AngioDynamics. With Namic, AngioDynamics gains a foothold in the cardiology market, creating opportunities to drive peripheral vascular product sales and better serve these clinicians and their institutions. Additional growth will be brought by AngioDynamics’ VenaCure EVLT® laser varicose vein therapy. In Oncology/Surgery, AngioDynamics’ growing radiofrequency ablation product lines and NanoKnife® System will be augmented by microcatheters from Navilyst.

The Board of Directors of both companies have unanimously approved the proposed transaction, which is expected to close during the Company’s fiscal 2012 fourth quarter ending May 31, 2012, and is subject to customary closing conditions, clearance under certain antitrust guidelines and the approval of AngioDynamics’ shareholders.

About AngioDynamics. AngioDynamics, Inc. is a provider of minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics’ product lines include ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.

About Navilyst Medical. Navilyst Medical, headquartered in Marlborough, MA, was formed in February 2008 from Boston Scientific’s Fluid Management and Vascular Access business units. Its breakthrough products, including the Pasv Valve Technology, Xcela® PICC and Namic® Fluid Management devices, help hospitals create clinical and economic solutions for their patients. The Company distributes its products worldwide and has its lead U.S. manufacturing facility in Glens Falls, NY. For more information, please visit: www.navilystmedical.com.

Siemens 3-D Angiography Imaging Software Cleared by FDA

New processing software simplifies workflow for minimally invasive heart valve implantation

Siemens Healthcare recently received clearance from the U.S. Food and Drug Administration (FDA) for syngo Aortic ValveGuide, an integrated image processing software that helps cardiologists and cardiac surgeons prepare and perform transcatheter aortic valve replacement (TAVR). The syngo Aortic ValveGuide automatically reconstructs a 3D representation of the aortic root from cross-sectional images acquired with the angiography system and provides the best projection angle for the valve replacement. The software selects anatomical landmarks and overlays the 3D image with 2D images acquired during live fluoroscopy, enabling the physician to obtain real-time 3D guidance in the patient’s body while navigating the new valve to its intended location.

During the minimally invasive TAVR intervention, an artificial aortic valve is inserted via the femoral artery or through the apex of the heart. syngo Aortic ValveGuide provides the physician with automated 3D guidance by segmenting the aortic root in 3D mode from images created using the angiography system. With the aid of anatomical landmarks in the 3D vessel representation, syngo Aortic ValveGuide calculates the exact perpendicular view on the aortic root. The C-arm adjusts to the corresponding angulations for live fluoroscopy, enabling the physician to precisely position the new valve. Consequently, as soon as the software overlays the 3D image of the aorta with the 2D live fluoroscopy, the cath lab cardiologist — or, respectively, the heart surgeon in the hybrid OR — can begin the intervention. Since syngo Aortic ValveGuide only requires a short fluoroscopy time prior to the procedure, the patient’s exposure to radiation and contrast can be reduced considerably.

Prior to syngo Aortic ValveGuide, users had to rely on preprocedural (or intraprocedural) CT, manually co-registering it with live fluoroscopy and overlaying it on a live fluoroscopy image to determine the correct angulation. This process required additional steps and highly skilled personnel. The new syngo Aortic ValveGuide uses syngo DynaCT Cardiac — Siemens software that processes CT-like cardiac images from images acquired using the angiography system.

“syngo DynaCT allows us to evaluate the anatomy of the aortic root and the position of the coronary ostiae. The overlay of the intra-procedural 3D image over live fluoroscopy gives us an additional level of confidence for the valve implantation,” says William O’Neill, MD, professor of medicine and cardiology, executive dean for clinical affairs and interim-executive dean for research and research training at the Miller School of Medicine and chief medical officer at University of Miami Health System. “The automated workflow of the syngo Aortic ValveGuide makes the procedure easier — and the indication of a perpendicular view plane helps to make it even safer.”