EP News

Asahi Kasei Announces Agreement to Acquire ZOLL Medical

Asahi Kasei Corporation and ZOLL Medical Corporation jointly announced that Asahi Kasei, Japan’s leading diversified chemical manufacturer with businesses in the health care, chemicals and fibers, homes and construction materials, and electronics sectors, has entered into a definitive merger agreement with ZOLL, a manufacturer of resuscitation and critical care devices and related software solutions, pursuant to which Asahi Kasei will acquire ZOLL for approximately $2.21 billion. The transaction has been approved by the Boards of Directors of both companies.

Asahi Kasei, through a U.S. subsidiary, will make a cash tender offer to purchase all of the outstanding shares of ZOLL common stock for $93 per share. The purchase price represents a premium of 29.6% over ZOLL’s volume weighted average closing stock price over the 30 trading day period ended March 9, 2012, and a 23.8% premium over the closing price on March 9, 2012. The tender offer is expected to commence within 10 business days and will remain open for a minimum of 20 business days. Closing of the tender offer is subject to customary conditions, including receipt of applicable regulatory clearances and the minimum tender of at least two-thirds of the outstanding shares of ZOLL (on a fully diluted basis). The transaction is not subject to a financing condition. The ZOLL Board of Directors has recommended that ZOLL stockholders accept the offer and tender their shares into the offer when it is made. The transaction is expected to close in the second calendar quarter of 2012.

Following the completion of the tender offer, Asahi Kasei intends to implement a second-step merger pursuant to which all remaining shares of ZOLL common stock not tendered in the offer will be converted into the right to receive the same cash price per share as in the offer. Upon completion of the merger, ZOLL will become a wholly owned subsidiary within the Asahi Kasei Group, managed by the current ZOLL management team and with all current business units and operations remaining intact. ZOLL will also be delisted from the NASDAQ stock exchange at that time.

Moving forward, Asahi Kasei plans strategic investments to accelerate the realization of ZOLL’s mission of leading the world in resuscitation technologies, and to build on the ZOLL platform to achieve Asahi Kasei’s long term strategic objective of creating a globally competitive health care business with a clear and unique focus on the field of critical care. Asahi Kasei has identified health care as a key strategic sector that will power a new phase of growth for the group, and believes that the acquisition represents a significant milestone in fulfilling its core vision for the health care sector: improving patient quality of life through the creation of innovative technologies and devices for critical care.

The acquisition extends the development of Asahi Kasei’s “Health Care for Tomorrow” project, under which the company seeks to advance the development of new businesses through organic growth, targeted acquisitions, and strategic alliances. A key focus area of this effort is the resuscitation sector, an area where ZOLL is already a market leader in the U.S. and has a strong international market presence. This transaction builds on the alliance between the two companies that was announced in July 2011, under which Asahi Kasei has exclusive rights to market and distribute ZOLL’s AED PLUS™ automated external defibrillator (AED) in Japan — the first AED in Japan with a function supporting cardiopulmonary resuscitation (CPR) that incorporates voice guidance and message displays.

ZOLL’s comprehensive set of technologies helps clinicians, emergency medical technicians, and fire professionals treat victims needing resuscitation and critical care. ZOLL develops products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, and therapeutic temperature management. Its innovative product lines, which include LifeVest™, the world’s only wearable automatic defibrillator; temperature management technologies for managing the core body temperature of critically ill or surgical patients; and AutoPulse™, a revolutionary non-invasive cardiac support pump, represent significant potential drivers of growth for the company.

Commenting on the transaction, President and Representative Director of Asahi Kasei, Taketsugu Fujiwara, said, “We are very excited to be joining forces with ZOLL, with whom we have enjoyed a productive partnership over the past nine months. In the medical devices business, the U.S. market leads the world, not only in size and scope, but also in technological innovation, so establishing a strong infrastructure in the U.S. is an important step for Asahi Kasei. This transaction will allow us to build on ZOLL’s strong U.S. business position and its technology leadership, with ZOLL forming the cornerstone of our critical care business. Together we will pursue new opportunities in the high-growth markets of Asia. We look forward to working with the management and all the employees of ZOLL to develop a critical care business renowned worldwide for its ability to turn technological advances into sophisticated medical tools that save lives and deliver invaluable improvements in the quality of life of patients and their families.”

Richard A. Packer, Chief Executive Officer of ZOLL, commented, “We are delighted with this transaction and believe that it is in the best interest of our shareholders. In addition, we are convinced that Asahi Kasei’s ownership will create the right environment for ZOLL and its team to continue transforming the science of resuscitation. We believe that Asahi Kasei will provide the right kind of support to help launch ZOLL’s next phase of growth, and we are excited to be working together with Asahi Kasei. We expect all parts of ZOLL to continue to thrive as part of Asahi Kasei.”

UBS Investment Bank is acting as financial advisor to Asahi Kasei and Cleary Gottlieb Steen & Hamilton LLP is acting as Asahi Kasei’s legal counsel. Brown Brothers Harriman is acting as financial advisor to ZOLL and Goodwin Procter LLP is acting as ZOLL’s legal counsel.

Boston Scientific to Acquire Cameron Health, Inc.

Boston Scientific Corporation announces the exercise of its option to acquire Cameron Health, Inc., a privately held company based in San Clemente, California. Cameron Health has developed the world’s first and only commercially available subcutaneous implantable cardioverter defibrillator – the S-ICD^® System. Unlike conventional implantable cardioverter defibrillators (ICDs), which require thin, insulated wires (leads) to pass through the venous system and into the heart, the entire S-ICD System sits just below the skin and leaves the heart and blood vessels untouched. This one-of-a-kind technology has the potential to expand the reach of ICD therapy, offering physicians and appropriate patients a new alternative to traditional ICDs, while strengthening Boston Scientific’s arrhythmia management portfolio.

The S-ICD System has received CE Mark and has been commercially available in select geographies, including several major European countries, since 2009. The system has been clinically evaluated in a variety of studies and has been implanted in more than 1,000 patients worldwide. Cameron Health received expedited review status and submitted its PMA application to the U.S. Food and Drug Administration (FDA) in December 2011. Boston Scientific anticipates FDA approval for the S-ICD System in the first half of 2013.

“With Cameron, we gain a strong, experienced team of professionals who are pioneers in this novel technology, and we are thrilled to welcome them to Boston Scientific,” said Hank Kucheman, Chief Executive Officer of Boston Scientific. “The acquisition of Cameron Health builds on Boston Scientific’s commitment to introducing innovation in the CRM space and represents an important part of our strategy to generate top-line revenue and market share growth. We believe that the S-ICD System represents a breakthrough treatment for patients at risk of sudden cardiac arrest and strengthens our ability to deliver value to physicians, their patients and healthcare systems around the world. We expect that the S-ICD System, combined with recent ICD and CRT-D launches, upcoming pacemaker launches, and the recently acquired WATCHMAN^® left atrial appendage closure device, will create a compelling and highly differentiated portfolio of arrhythmia management products,” continued Kucheman.

“The S-ICD System represents a new category of rhythm management devices that is unlike anything available today,” said Kenneth A. Ellenbogen, MD, FACC, Professor of Medicine and Director of the Electrophysiology Laboratory at the Medical College of Virginia. “This system provides physicians with a new alternative in the treatment of patients at risk for sudden cardiac arrest and should become first-line therapy for patients who may benefit from not having a lead in the heart.”

“The S-ICD System was designed to eliminate the complications associated with transvenous leads, creating an important new treatment option for patients at risk of sudden cardiac arrest,” said Kevin Hykes, President and CEO of Cameron Health. “We look forward to joining the Boston Scientific team, which will allow us to expand our commercialization efforts and bring this proven therapy to more patients around the world.”

The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150 million payment upon FDA approval of the S-ICD System, plus up to an additional $1.050 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval. The Company expects to fund these payments through the cash flow of its business. The Company currently expects the transaction to be approximately $0.01 dilutive in 2012 and approximately break-even in 2013 to earnings per share on an adjusted basis and more dilutive in both years on a GAAP basis as a result of acquisition-related net charges and amortization, which will be determined following closing of the transaction. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.

The S-ICD^® System is restricted under Federal law for investigational use only and is not for sale in the U.S.

TYRX Announces Launch of New Patient Education Web Site HeartDeviceInfection.com

TYRX^®, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections, announced the launch of its new patient education web site, HeartDeviceInfection.com.

HeartDeviceInfection.com, targeting patients and caregivers, has been created to raise awareness of surgical site infection associated with cardiac implantable electronic devices (CIEDs) including pacemakers and implantable defibrillators, and to offer information and resources for reducing that risk.

“With CIED infections growing much faster than implantations, being very expensive to treat, and having a one-year mortality rate of ~30%, it is very important to widely and rapidly educate patients and caregivers that there is technology available that can help prevent these infections,” stated Dr. Charles Kinder, Director, Heart Rhythm Program, Heart Care Centers of Illinois.
By launching HeartDeviceInfection.com, we are able to reach a very broad and diverse audience of patients and caregivers looking for information to address their heart health concerns. HeartDeviceInfection.com will serve as an important resource to help reduce the number of cardiac device infections impacting patients and the heath care system,” stated TYRX CEO, Robert White.

About TYRX, Inc.

TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx^® Antibacterial Envelope, designed to reduce surgical-site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in implantable pacemaker and defibrillator related endocarditis, including “superbugs” or MRSA*. Following commercial release, the AIGISRx Envelope has been used in over 25,000 patients nationwide. The company estimates that over 2% of all U.S. implantable pacemaker and defibrillator patients in 2012 will receive an AIGISRx product during their procedure.

TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center.

* Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009; 32(7) 898-907.

eCardio Announces Publication of Manuscript on the Use of Mobile Cardiac Telemetry to Improve Diagnostic Accuracy and Enable More Efficient Patient Care

eCardio Diagnostics, a leading provider of remote cardiac arrhythmia monitoring, announced the acceptance for publication of the manuscript titled, “The Use of Mobile Cardiac Telemetry to Improve Diagnostic Accuracy and Enable More Efficient Patient Care.” The article appears in the Arrhythmia Section of US Cardiology journal’s February issue and is currently available online.

The manuscript’s lead author, Steven Zweibel, MD, FACC, FHRS, wrote that even though mobile cardiac telemetry (MCT) is a relatively new technology (first approved by the U.S. Food and Drug Administration in 2002), the use of it has been proven to provide superior diagnostic capability for patients with palpitations, syncope, and pre-syncope because it allows for detection of both symptomatic and asymptomatic arrhythmias, including atrial fibrillation (AFib).

Dr. Zweibel is Director of Electrophysiology at Hartford Hospital and Assistant Professor of Medicine for the University of Connecticut School of Medicine.

The article references a specific patient case study of a 56-year-old male with a history of palpitations with documented runs of both supraventricular tachycardia and AFib. Because the MCT monitor provides specific documentation on the initiation and termination of arrhythmias, Dr. Zweibel received the clinical detail he needed for diagnosing the patient, and he was able to determine that invasive procedures or medication trials would be unnecessary.

“We’re thrilled to have such a well-respected electrophysiologist reaffirming the superior clinical benefits of MCT monitors as a cost-effective diagnostic alternative to other available technologies,” said Larry Lawson, President and Chief Executive Officer of eCardio Diagnostics.

“I also believe nationwide insurance carriers will find additional value in documented patient case studies such as Dr. Zweibel’s study,” said Lawson. “Moving forward, and in the context of total patient healthcare, I hope more insurance carriers will view MCT technology as a cost-conscious way to enable superior member outcomes.”

Additionally, Dr. Zweibel stated that the benefits of the MCT monitor were strengthened further through the use of eCardio’s uniquely designed Academic Medicine Site (AMS). AMS enables physicians to see data quickly, be alerted to critical and serious heart rhythms, and view reports at any time of day.

According to Paul Minardi, eCardio’s Vice President of Academic Medicine, AMS can be configured to the needs of each academic institution or teaching hospital based on their workflow. With AMS, they can track fellowship participation, gain confirmation from attending physicians, regenerate reports and time/date stamp each study with the user’s credentials, while allowing for a code of Federal Regulations 21 part 11, HIPAA-compliant electronic signature to be placed on studies.

Minardi said, “We launched eCardio with the belief that physicians needed flexibility, speed and accuracy not only with regards to the devices monitoring their patients, but also from the standpoint of how they would receive information on those patients throughout their studies and maintain that data within their own electronic medical records.”

AMS can be provided as a stand-alone tool or customized to work with a variety of EMR systems, and it is continually enhanced as feedback is gained from thousands of end users.

About eCardio

eCardio Diagnostics, LLC is one of the nation’s leading providers of comprehensive and advanced technologies, devices, services and solutions for the diagnosis, monitoring and subsequent clinical management of cardiac arrhythmias, predominantly in an ambulatory setting. eCardio provides leading-edge diagnostic innovations and solutions that optimize the flexibility, speed and accuracy of cardiac arrhythmia diagnoses.

About Hartford Hospital

Hartford Hospital, founded in 1854, is one of the largest teaching hospitals and tertiary care centers in New England with one of the region’s busiest surgery practices. It is annually ranked among America’s Best Hospitals by US News & World Report and has been recognized nationally for the quality of many of its programs, including cardiology, cancer, stroke and joint and spine care. The 867-bed regional referral center provides high-quality care in all clinical disciplines. Among its divisions is The Institute of Living, a 114-bed mental health facility with a national and international reputation of excellence. Jefferson House, a 104-bed long-term care facility, is also a special division of Hartford Hospital. The hospital’s major centers of clinical excellence include cardiology, oncology, emergency services and trauma, mental health, women’s health, orthopedics, bloodless surgery and advanced organ transplantation. Hartford Hospital owns and operates the state’s only air ambulance system, LIFE STAR.

About US Cardiology

US Cardiology is a peer-reviewed biannual journal comprising review articles, case reports, practice guides, theoretical discussions, and original research. It features balanced and comprehensive articles written by leading authorities, addressing the most important and salient developments in the field of cardiology.

Medtronic Receives CE Mark for Pacemaker Lead That Will Expand Patient Access to MRI Technology

Medtronic, Inc. announced the receipt of CE Mark (Conformité Européenne) and launch of the CapSure Sense MRI^™ SureScan^® pacing leads, which are approved for use during Magnetic Resonance Imaging (MRI). Medtronic introduced the first MR-Conditional pacemaker system in the world in 2008 and in the U.S. in 2011.

The newly approved leads are the smallest MR–Conditional leads available in the world. As passive-fixation leads (which attach to the heart with small tines), they will give physicians an additional option that is MR-Conditional, or designed to be safe for the MRI environment when used per the specified MR Conditions for Use.¹ Previously approved Medtronic MR–Conditional leads are active fixation leads, which fasten directly into the cardiac tissue.

With approximately 60 million MRI procedures performed worldwide each year,² there has been increasing demand for MR–Conditional pacing systems. MRI procedures are indicated for 17 percent of pacemaker patients within 12 months of device implant.³

“The CapSure Sense MRI SureScan^® leads address an unmet clinical need for thoroughly tested MRI conditional passive fixation leads,” said Gianluca Botto, MD, director of EPS Unit at St. Anna Hospital in Como, Italy. “With this new lead, there is now a full portfolio of options available for physicians and their patients, when this lead is combined with an MR–Conditional device.”

To assure the safety of patients and the effectiveness of the patients’ pacing therapy, the CapSure Sense MRI leads were tested in more than 400,000 scenarios that evaluated different patient body types, scanning locations, MRI scanner types and lead lengths.

“Now patients and physicians will have access to MRI passive leads approved for full body MRI scans,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “This is a major step forward in addressing both patient access and providing physician options.”

References

1. Wilkoff B, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm 2011;8:65-73.
2. Sutton R, Kanal E, Wilkoff BL, et al. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: Clinical study design. Trials 2008;9:68.
3. Sommer T, Naehle CP, Yang A, et al. Strategy for safe performance of extrathoracic magnetic resonance imaging at 1.5 Tesla in the presence of cardiac pacemakers in non–pacemaker-dependent patients: A prospective study with 115 examinations. Circulation 2006;114:1285-1292.

Heart Rhythm Society Releases Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation

The Heart Rhythm Society (HRS), written in joint partnership with European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS), issued an international consensus statement on indications, techniques and outcomes of catheter and surgical ablation of atrial fibrillation (AF).

The HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of AF is an update to the first AF consensus document released in 2007, and is published in the March edition of HeartRhythm, the official journal of the Heart Rhythm Society. The new statement was written in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS).

AF is one of the most common heart rhythm disorders affecting more than 2.5 million Americans and millions more around the world. Today, catheter and surgical ablation of AF are common, rapidly evolving procedures. The HRS/EHRA/ECAS expert consensus statement includes recommendations for patient selection, producer techniques, management and follow-up, new definitions and research trial design, among other updates.

“It is without question that AF is a growing heart health issue requiring state-of-the-art treatment to ensure the best possible outcome,” stated co-lead author of the statement, Hugh Calkins, MD, FHRS, CCDS, first vice president of the Heart Rhythm Society, professor of medicine at the Johns Hopkins University School of Medicine and director of cardiac arrhythmia services and the electrophysiology laboratory at The Johns Hopkins Hospital. “As we continue to learn more about the treatment of AF, it is important to update our resources accordingly, and in this case, our document is intended to improve patient care by providing the most current foundation of knowledge for those involved in catheter and surgical ablation of AF.”

HRS convened a diverse panel of 45 experts representing seven international organizations to focus on the most recent advancements in the field of catheter and surgical ablation. The expert consensus statement includes 11 topic areas:

• AF definitions, mechanisms and rationale for ablation
• Indications for catheter and surgical ablation of AF
• Techniques and endpoints for AF ablation
• Technologies and tools
• Other technical aspects; anticoagulation, anesthesia and esophageal monitoring
• Follow-up considerations
• Outcomes and efficacy of AF ablation
• Complications
• Training requirements and competencies
• Surgical ablation of AF
• Clinical trial considerations and definitions

Specifically, the statement provides notable updates in the areas of indications and techniques. These updates include, but are not limited to the following:

• The addition of class and level of grades of indications for catheter and surgical ablation of AF when performed by an electrophysiologist or surgeon who has received the proper training and/or has a certain level of experience.
• The specific recommendations regarding the management of anticoagulation strategies before, during and post-ablation, including information on newer anticoagulants.
• A list of 53 definitions intended to guide clinical research.

“It is important to note the highly collaborative nature of this document and the comprehensive recommendations that have been put forth by an international panel of experts in our field,” stated Bruce L. Wilkoff, MD, FHRS, CCDS, president of Heart Rhythm Society. “This statement, along with other consensus documents issued on an annual basis, is intended to provide a uniformed standard of care with the goal of improving the overall safety and efficacy of patient care around the world.”

About the Heart Rhythm Society

The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of more than 5,100 heart rhythm professionals in more than 72 countries around the world.