Cath Lab Digest - September 2007 - (Page 52)

52 CLINICAL AND INDUSTRY NEWS SEPTEMBER 2007 Miniature Blood Pump from CircuLite Successfully Implanted in First Chronic Heart Failure Patient Synergy Device Designed to Provide Partial Circulatory Assist in Patients with Chronic Heart Failure C ircuLite™, Inc. reported the launch of the company’s clinical development program for its Synergy™ Pocket Circulatory Assist Device with the successful implantation of the first patient in a European feasibility trial. Synergy is a miniature implantable blood pump, the size of a AA battery, that can be implanted superficially in a pocket, like a pacemaker. The device is designed to provide longterm, partial circulatory support in patients with chronic heart failure. The primary objective of the first-in-man trial is to assess the safety of the device in patients with chronic heart failure who are waiting to receive heart transplants. Bart Meyns, MD, PhD, Professor and Chief of Cardiac Surgery at Gasthuisberg University Hospital (Katholieke Universiteit) in Leuven, Belgium, performed the first implant. “The first implant of the Synergy device was very successful and the patient has already been discharged home and is doing very well,” said Prof. Meyns, principal investigator of the trial. “While CircuLite’s feasibility clinical study is in a bridge-to-transplant setting, the ultimate need for this type of device will be among those chronic heart failure patients who may not be eligible for a heart transplant. A partial support approach to chronic heart failure treatment may be better able to address the treatment needs and improve the quality of life for this unserved group of patients, who otherwise have no other options.” The CircuLite technology is designed to provide a new treatment option for over two million chronic heart failure patients worldwide who continue to be significantly symptomatic despite appropriate, optimal medical and device-based therapies. While feasibility studies will examine the hemodynamic and clinical effects of the Synergy device in patients that are awaiting heart transplants, CircuLite’s ultimate goal is to expand the treatment of heart failure to the chronic, ambulatory patient in order to improve their quality of life by giving them an elective, less-invasive option to increase blood flow from the heart. The Phase I study will include up to three European hospitals and will enroll chronic heart failure patients awaiting heart transplantation and whose heart function is in a state of decline. Patients will be surgically implanted with the device. The trial will evaluate the safety of the device for up to six months. CircuLite developed this trial to evaluate Synergy in a surgical, bridge-totransplant setting in order to collect initial data to establish clinical proof-ofconcept; however, the further development of the device will be focused on nonsurgical, endovascular implantation for use as a long-term therapy. “The current trial design is an important first-step for our Synergy device, but our eventual plan is to utilize a minimally invasive procedure and for patients to be implanted with the device sooner, before they have reached the later stages of chronic heart failure. This treatment paradigm would ensure that patients could benefit as much as possible from this long-term therapy,” said Daniel Burkhoff, MD, PhD, CircuLite’s Medical Director and Adjunct Associate Professor of Medicine at Columbia University Medical School. The Synergy Pocket Circulatory Device is a small implantable blood pump designed to provide long-term, partial circulatory support to patients with chronic heart failure. The key component of the Synergy device is the proprietary and patented micro-pump technology acquired after eight years of development at the Helmholtz Institute in Aachen, Germany, in collaboration with Katholieke Universiteit in Leuven, Belgium. The device is designed to be small enough to be implanted subcutaneously in the “pacemaker pocket” through a minimally invasive procedure. Synergy is designed to supplement the heart’s native pumping function, potentially increasing blood flow and allowing the heart to rest and potentially recover, possibly improving the quality of life of chronic heart failure patients. For more information, visit www.circulite.net. ■ Restricting Blood Flow May Help Heart Bypass Patients I n a potentially significant discovery for heart bypass patients, British researchers are reporting that limiting blood flow to an arm before surgery produced better results in a small trial of patients. Restricting blood flow before surgery reduced levels of troponin T, a cardiac protein that is released into the bloodstream after injury to the heart and is associated with poor outcomes after surgery, the researchers said. “If you remotely precondition the heart before surgery, you get significant protection,” said study researcher Dr. Derek Yellon, of University College London's Hatter Cardiovascular Institute. “You can significantly reduce troponin T in patients undergoing bypass surgery.” “Remote preconditioning is a phenomena in which, if one deprives the blood supply to an organ or tissue, other than the heart, that initiates a protective mechanism on the heart,” added study lead author Dr. Derek J. Hausenloy, also from the Hatter Cardiovascular Institute. The findings are published in the Aug. 18 issue of The Lancet. In the trial, the British researchers restricted blood supply to the heart by restricting blood flow in an arm. Yellon and Hausenloy studied 57 patients undergoing coronary artery bypass surgery. Twenty-seven of the patients underwent heart preconditioning — restrictions of blood flow — before the operation. Preconditioning consisted of three, five-minute cycles of restricting blood FoxHollow Technologies Introduces SilverHawk EXL F Continued on next page oxHollow Technologies, Inc. launched its latest advancement in plaque excision technology: the SilverHawk® EXL. This device is designed to remove atherosclerotic tissue that blocks arteries in the lower leg of patients suffering from peripheral artery disease (PAD). The SilverHawk EXL has a lengthened nosecone and includes MEC ™ (Micro Efficient Compression) Technology, featuring laser-drilled vent holes in the tip of the catheter. These micro vent holes release fluid pressure, providing more space for the collection of tissue in the tip of the device. When combined with the longer nosecone, this new technology allows for increased tissue collection capacity. These improvements may shorten overall procedure time by reducing the number of insertions required by the physician to remove the diseased tissue. In vitro bench test results demonstrate nearly five times more tissue capture per insertion than the previous device. The SilverHawk catheters utilize a tiny rotating blade to shave plaque from artery walls and a reservoir nosecone to collect the excised plaque from the patient. ■ http://www.circulite.net

Table of Contents Feed for the Digital Edition of Cath Lab Digest - September 2007

St. Dominic Hospital The Genous Bio-engineered R Stent Percutaneous Treatment of Peripheral Arterial Chronic Total Occlusions: Device Options and Clinical Outcomes Contents Clinical Editor’s Corner Percutaneous Revascularization of Peripheral Chronic Total Occlusion — Which Patients, Why, and How? Myocardial Infarction and Syncope: A Manifestation of the “Raynaud-Prinzmetal Syndrome”? Essential Technical Components of the Transradial Approach If You Build It, Will They Come? Evidence-Based Medicine with Drug-Eluting Stents Back to School: The Value of Education in Cardiovascular Services The ACVP Standards and Competencies: Are You Using Them Effectively? What Do You Think? My Experience with Fibromuscular Dysplasia and Stroke A Brief Review of Fibromuscular Dysplasia Letter to the Editor A Look at On-the-Job Training: Perceptions, Reality and Our Profession Doing the Wave: Inventory Management with RFID The Ten-Minute Interview with… Paul Pinsker, RCIS CLD’s Annual Salary Survey Harrisburg Area Community College Volunteer Survey CEU Education Center SICP* Section Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Clinical & Industry News

Cath Lab Digest - September 2007

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