Clinical and Industry News for April 2007

CircuLite Closes $20 million Series B Private Placement Funding Foundation Medical Partners Led Round CircuLite Incorporated, a medical device company focused on the development of a proprietary circulatory assist technology for the management of chronic heart failure, announced the closing of a $20M Series B private placement. Existing investors, including Forbion Capital Partners (formerly ABN AMRO Life Sciences) and Oxford Biosciences Partners, as well as new partners, Foundation Medical Partners, the lead investor, and SB Life Science Ventures participated in the Series B financing. The Series B funding will support the company's First-in-Man trial in 2007 and the start of the United States investigational device exemption Phase I Feasibility trial enrollment in 2008. Paul Southworth, President and Chief Executive Officer of CircuLite, said We are very excited about the clinical potentials of the Synergy Pocket Circulatory Assist device and are confident that the clinical trial outcome data will demonstrate positive clinical benefits in the management of patients with chronic heart failure." Over 5 million patients suffer from heart failure in the United States and there are approximately 500,000 new cases diagnosed each year. For approximately 1 million chronic heart failure patients in the U.S., the disease has progressed to a state in which the patients are receiving limited or no clinical benefit from conventional medical therapy, resulting in a diminishing quality of life. CircuLite has developed a truly unique technology. It is tiny relative to today’s surgical devices and can be placed minimally invasively. This should be attractive to a large group of heart failure patients who currently are not well-treated by conventional medicine, said Bartley Griffith, MD, Chief of the Division of Cardiac Surgery and Director of Heart and Lung Transplantation in the Department of Surgery at the University of Maryland in Baltimore, MD. This miniature device is intended to provide increased cardiac output for these patients, reducing their heart failure symptoms. A device such as the Synergy device is truly needed and has the potential to significantly improve the quality of life of millions of chronic heart failure patients. The company’s Synergy Pocket Circulatory Assist device is in preclinical studies and the company is preparing for the First-in-Man implant in 2007. The Synergy device features a micro-pump that is placed superficially in the pacemaker pocket. The micro-pump is minimally invasively connected to the left atrium and the subclavian artery, and can pump up to 3 liters of blood flow per minute. The minimally invasive placement of the device will allow the transformation of the treatment of chronic heart failure patients from the acute decompensated hospitalized patient to the chronic, ambulatory heart failure patient. The company was founded in 2004 by Accelerated Technologies, Inc. and is headquartered in Hackensack, New Jersey with a GmbH in Aachen, Germany. St. Jude Medical Named Fortune Magazine‘s Most Admired Medical Products and Equipment Company St. Jude Medical, Inc. announced that Fortune Magazine has named it one of America’s Most Admired Companies for 2007. St. Jude Medical ranked No. 1 in the Medical Products and Equipment Companies category. The Most Admired Companies list is included in the March 19 issue. St. Jude Medical is delighted to be recognized yet again by one of the most respected and influential financial publications in the world, said Daniel J. Starks, chairman, president and CEO of St. Jude Medical. This honor is a tribute to the more than 11,000 St. Jude Medical employees around the globe who make life better for patients and who excel in the medical device industry. Fortune Magazine uses a rigorous assessment to determine a company’s overall reputation, including measurements of innovation, people management, use of corporate assets, social responsibility, quality of management, financial soundness, long-term investment and quality of products and services. St. Jude Medical ranked either first or second in the medical products category for: people management, use of corporate assets, quality of management, financial soundness, long-term investment and quality of products and services. Mobile Aspects Releases Next Generation of RFID-Enabled Medical Device and Supply Management System Mobile Aspects, Inc., announced the general availability of iRISupply 4.0, the next generation of its RFID (radio frequency identification)-enabled medical device and supply management system. Common benefits to medical device and supply utilization management include more accurate charge capture, improved security and retrieval of stored items, optimization of inventory levels and elimination of product expiration. Major features include: Adjustable shelving. RFID-enabled shelving within the cabinet-based technology is now adjustable. Re-configurable cabinets. The new cabinet design allows Mobile Aspects to re-configure the cabinet storage design on-site. Increased storage capacity. Storage capacity per cabinet has increased while taking up less floorspace. Shelf lighting. Lighting has been embedded within the cabinet shelving. Increased cluster scalability. For facilities who seek to store larger volumes of inventory within a small proximity area, the new version of iRISupply allows for an increased number of cabinets to be included in a single cluster of cabinets. Next generation of RFID tracking architecture. iRISupply 4.0 utilizes a patent pending three-dimensional reading capability for the tracking and management of medical devices and supplies. The first client to implement iRISupply 4.0 will be the Columbus Children’s Hospital in Ohio, in their two specially designed hybrid cardiac catheterization suites. Mobile Aspects can be found on the web at www.mobileaspects.com. Boston Scientific Announces Program to Improve Anti-Platelet Compliance for DES Patients Boston Scientific Corporation announced a program designed to improve patient compliance with physician-prescribed anti-platelet therapy following implantation of a drug-eluting stent (DES). This program is the first of its kind in the medical device industry and is expected to launch in the United States later this year. It will be made available to all patients who receive a DES, regardless of brand, through their prescribing physician. The program will consist of three core components: An education module offered to DES patients, designed to increase awareness of the importance of following physician-prescribed anti-platelet plans after DES implantation; A patient adherence program, designed to assist patients in complying with their anti-platelet therapy; and A patient assistance program designed to facilitate access to financial support for anti-platelet therapy for patients who qualify. The company said it plans to spend up to $40 million on the program and will begin training for the initial education component of the program immediately. Paul LaViolette, Chief Operating Officer of Boston Scientific, said, We are pleased to offer this program to all DES patients, not just Taxus patients, to encourage participation in the program for all physicians. We expect these efforts will increase compliance and optimize clinical outcomes for DES patients. Second Major Study of Carotid Stenting Reproduces Results of Previous Large Study and Proves Treatment is Safe and Effective for High-Risk Patients to Prevent Stroke CASES-PMS Trial of Carotid Stenting with Embolic Protection in High Surgical Risk Patients Shows Similar Results Regardless of Hospital, Physician Volume, or Physician Experience Via a Formal Training Program A multi-center, prospective, single-arm trial of 1,493 patients adds to the growing body of evidence that carotid stenting with embolic protection is safe and effective for patients at the highest risk for adverse events, and substantiates the low adverse event rates reported previously in the SAPPHIRE trial. The preliminary one-year data from 73 sites, presented at the Society of Interventional Radiology’s 32nd Annual Scientific Meeting, compares the outcomes of patients in the CASES-PMS trial to those of the SAPPHIRE trial stent cohort, and confirms the long-term results and safety profile of carotid stenting with embolic protection in patients who are high-risk for surgery or whose surgery failed the population for whom the treatment is currently approved. The overall stroke rate in the CASES-PMS trial was 4.8 percent at one year. This trial studied the treatment using a embolic protection with the stent. Physicians of varying experience levels at multiple institutions performed the carotid artery stenting utilizing a formal training program and had similar adverse event rates to the highly experienced experts in the SAPPHIRE trial, showing that the training program is valuable and can contribute to patient safety in introducing a relatively new interventional procedure into the mainstream. The primary endpoints of the study measured the 30-day major adverse event rate (MAE) death, stroke and heart attack which were likely to be procedure-related events, and the one-year MAE, which included the 30-day rate plus death and same-side stroke from 31 days to one year. The preliminary one-year cumulative MAE of 11.9 percent in the CASES-PMS trial is similar to the 12.2 percent rates seen with the SAPPHIRE trial stent cohort, and lower that the 20.1 percent for the surgical arm of the SAPPHIRE trial. The CASES-PMS overall stroke rate at one-year was 4.8 percent (seven percent in symptomatic patients and 4.2 percent in asymptomatic). Patients with severely blocked carotid arteries are at high risk for stroke, but many patients with vascular disease are not good candidates for surgery. Now we know we can safely offer these high-risk patients carotid stenting, saving many people from future strokes, says Barry T. Katzen, MD, interventional radiologist, Baptist Cardiac and Vascular Institute, Miami, FL. The CASES-PMS trial was designed to assess the safety and efficacy outcomes of carotid artery stenting using the Cordis Precise® Nitinol Stent and Angioguard Emboli Capture Guidewire, when performed by physicians with varied experience in carotid artery stenting utilizing a formal training program. The study demonstrated that using a detailed training program in carotid artery stenting for physicians with various levels of experience produced outcomes that were similar to those of the highly experienced physicians who participated in the SAPPHIRE trial. We are excited to see a similar safety profile for physicians who were involved in the training program at 73 different sites. This is an excellent model to introduce a new technique very safely into the mainstream, and will allow us to train more physicians, enabling more patients to have this important treatment to prevent stroke, says Dr. Katzen. WaveMark, Inc. is Honored with the RFID Excellence in Business Award WaveMark, Inc. is proud to announce it has been honored with the Excellence in RFID Implementation Award from a field of 96 applicants, as presented by CMP Media and RFID Revolution. The award was earned based on the installation of WaveMark’s RFID-based inventory and usage tracking system in Mercy Medical Center’s six-room cardiac catheterization lab. Sixteen RFID-enabled, 13.56MHz WaveMark smart cabinets were installed in procedure rooms and in storerooms, allowing the cath lab to monitor their inventory of costly consumable supplies, such as cardiovascular stents. In addition, RFID Point of Service (POS) readers are located in the control rooms, where documenting of cases is done, to capture real-time product usage. Each cabinet and POS reports its product status to the WaveMark database. The resulting information is visible via a secure web interface and presented in a series of reports and decision support tools. The judges looked for extensive collaboration between vendors, end-users and suppliers, as they evaluated the submissions. Together, Edwards and WaveMark established a pilot program for Mercy to trial WaveMark’s RFID inventory management solution. By providing pre-tagged products, Edwards Lifesciences illustrated the value of a vendor-customer partnership in the RFID realm. Tagging product at the point of manufacture allowed Edwards to see the movement of their product from the distribution center to customer location to procedure use. Prior to the implementation of WaveMark, over 2,000 items were hand-counted by Mercy each morning, product requisitions were entered manually into the materials system for transmittal to vendors, and there was no system in place to manage expiring or recalled items. This manual process was labor-intensive and prone to error. Implementing WaveMark produced dramatic improvements in all of these areas, such as a projected 30% reduction in high-cost inventory, annual labor savings of approximately 400 hours, and reduced waste of perishable product. These results were made possible with minimal hospital IT resources and no capital expense. WaveMark, Inc. provides inventory management solutions to hospitals and surgery centers. It is headquartered in Boxborough, Massachusetts. More information is available at www.wavemark.net Cordis Corporation Launches Family of Regatta Steerable Guidewires Cordis Corporation announced the launch of the Regatta Steerable Guidewire family in the United States. The launch is marked by the introduction of 12 selections of the Regatta Steerable Guidewire and two choices of the Regatta SB Steerable Guidewire. In April, the company will also add the Regatta HS Steerable Guidewire in two selections. Cordis is offering the Regatta Guidewire family to provide tailored solutions for the placement of catheters and other interventional devices in coronary arteries. The Regatta Guidewires are all-purpose guidewires; the Regatta SB Guidewires are designed to facilitate access to side branches; and the Regatta HS Guidewires include features that ease placement in highly narrowed arteries. The different selections for each version refer to variations in tip type, tip profile, lateral support and/or wire length. All versions in the Regatta Guidewire family feature a next-generation hydrophilic coating technology that prevents swelling and a single-piece steel core wire that enhances torque. In addition, the Regatta Guidewires and the Regatta HS Guidewires offer a micro-ridge design for additional torque control. The Regatta HS Guidewires also feature a rounded wedge tip that facilitates the introduction of the wire in highly narrowed lesions, and the Regatta SB Guidewires come with an innovative shaping ribbon that is oriented in the plane of a J-shape, helping physicians locate and access side branches. The U.S. launch of the Regatta Guidewire family will be followed by market introductions outside the United States starting in a week. Cordis is the worldwide distributor of the Regatta Guidewire family as a result of an agreement between Cordis and Brivant Limited signed in 2006.

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