CD&D
and CD&D
A gentle hug.
That's the simple theory behind a treatment for congestive heart failure (CHF), using the strategy of wrapping the heart to support it and, hopefully further out, return it to improved function. The super elastic compliant nitinol structure of the HeartNet device, invented and manufactured by Paracor Medical (Sunnyvale, California), is placed around the heart and looks somewhat like the stretchy mesh material used to protect expensive produce, such as Asian pears.
Not just protecting the heart, HeartNet is designed to augment function, potentially preventing CHF from advancing, by reversing the progressive enlargement. In general, the strategy is similar to the CorCap made by Acorn Cardiovascular (Brighton, Minnesota).
Surgeons from Wayne State University School of Medicine (Detroit) and Oakwood Healthcare System (Dearborn, Illinois) successfully implanted the HeartNet device the first time in a 49-year-old patient in late March. After a four-day hospital stay, the patient went home and reported feeling better, according to the surgeons' report.
"The utility of HeartNet is that it may add to the armamentarium of devices and therapies to delay the progression of heart failure, or even halt it, to avoid advancement to mechanical therapy or a heart transplant," Salik Jahania, MD, a co-principal investigator and the cardiothoracic surgeon who performed the procedure, told Cardiovascular Device & Drugs. "This is a stand-alone therapy with a minimally invasive approach and a short hospital stay" the minimally invasive strategy being extra-important these days.
Paracor plans to enroll patients at up to 30 U.S. centers under an FDA-approved investigational device exemption. Designated Prospective Evaluation of Elastic Restraint to LESSen the effects of Heart Failure (PEERLESS-HF), the study will enroll 272 patients.
Regulator prospects for the device are somewhat qualified by Acorn's struggle to win FDA approval for its CorCap, a sort of jacket placed around the heart via an open surgical procedure. An FDA panel voted in 2005 against recommending PMA approval of CorCap. But the company appealed to the FDA going to its dispute resolution panel — and last spring, won approval for a 50-patient confirmatory trial.
William Mavity, president/CEO of Paracor, said, "My expectation ... is that [Acorn] will be successful. I expect them to get approved. Nobody else is doing this. There's room for a number of other players in this field. But our procedure is simpler [than Acorn's] and the morbidity, arguably, will be less."
HeartNet is implanted through an incision in the left side of the chest, guided by an X-ray camera projecting images on an operating room screen. The tool designed to introduce the HeartNet into the chest cavity contains a number of "fingers" that spread the mesh around the heart and then retract once the device is placed. The procedure typically takes 90 minutes or less.
"The novelty is that it can be implanted minimally invasively," Jahania said. "We open up small hole in pericardium, the lining around heart, and then a plastic tube is inserted in that hole. Through that hole, the crimped neck is delivered ... finger-like plastic extensions unfurl as we deliver the device around both chambers of the heart. Then we pull the handle, like a rip cord, and we withdraw the instrumentation. It's relatively easy to reach in there and adjust if needed. And it requires no suturing to stay in place."
Jahania said another trial, much larger than the current PEERLESS-HF study, will be needed to prove the morbidity benefit.
HeartNet is a permanent implant and does not prohibit future surgeries if needed.
Robert Mentzer Jr, MD, dean of the Wayne State University School of Medicine (Cleveland) and study co-principal investigator, said the implant could "reduce the need for heart transplants among some patients."
The PEERLESS-HF study targets New York Class II-III patients, those who are moderately sick and likely to need mechanical assist devices and heart transplants. These patients have had heart failure for at least six months, received standard therapy and have responded to the extent that they benefited, but continue to have symptoms that put them in Class II-III.
Mavity predicts study completion and approval of HeartNet by 2010 and commercialization of the device in a range of $10,000 to $15,000, potentially for a 200,000-patient population in the U.S.
Last year, Paracor raised $44.35 million in a Series D financing. "At the pace we're moving, it's enough to get us through the trial," Mavity said, but needing another cash infusion to win regulatory approval.
Elsewhere in the product pipeline:
• Abiomed (Danvers, Massachusetts) reporting receiving conditional approval from the FDA to begin its Impella 2.5 circulatory support system study in the U.S. under an investigational device exemption for hemodynamically unstable patients undergoing a percutaneous coronary intervention (PCI) procedure due to acute myocardial infarction (AMI). The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients as compared to optimal medical management with an Intra-Aortic Balloon Pump. There are estimated over 100,000 AMI anterior infarct patients annually in the U.S. These patients suffer failure of the left ventricle, the large main pumping muscle of the heart. Abiomed makes devices that provide circulatory support to acute heart failure patients.
•AtriCure (West Chester, Ohio) reported FDA clearance for its Coolrail linear ablation pen for the ablation of cardiac tissue. Additionally, the first patient was successfully treated using the pen. The Coolrail linear ablation pen is designed to facilitate the creation of an expanded cardiac ablation lesion set during a minimally invasive off-pump procedure. The ORLab system is a mapping, recording and stimulating system which enables electrophysiologists and surgeons to confirm, in the operating room, that the cardiac ablation lines being created are forming electrical barriers, or lines of conduction block. AtriCure makes cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue.
•ATS Medical (Minneapolis) reported the first North American commercial implant of the ATS 3f Aortic Bioprosthesis. ATS says the bioprosthesis uses design concepts intended to preserve native aortic root geometry and function. Through this approach, the company says that the prosthesis more closely mimics native valve function providing excellent hemodynamic performance that may contribute to improvements in key determinants of cardiovascular performance such as coronary blood flow and left ventricular mass regression. ATS makes cardiac surgery products and services.
•Biotronik (Lake Oswego, Oregon) said that the recruitment phase of the Lumos-T Safely Reduces Routine Office Device Follow Up (TRUST) study has been completed early. TRUST is a randomized, multicenter trial of patients with implantable cardioverter defibrillators (ICD) using Biotronik Lumos and Lumax devices. TRUST will evaluate the effectiveness of using Home Monitoring technology to follow-up patients compared to periodic in-office follow-up. Home Monitoring is an innovation in cardiac device technology that Biotronik says it has pioneered. It allows patients to be monitored continuously and wirelessly by their physician from anywhere in the world and from any computer with an Internet connection. Unlike other systems which require cardiac device patients to activate remote monitoring (sometimes using complicated technology), Home Monitoring is automatic, mobile and requires no patient intervention. Biotronik makes remote device patient management systems.
•CardioTech International (Wilmington, Massachusetts) reported receiving all of the necessary approvals to add a second medical center for the clinical trial of CardioPass, the company's synthetic coronary bypass graft. CardioPass is designed to be an effective alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20% of all bypass procedures. CardioPass is made from ChronoFlex, the company's proprietary biodurable medical-grade polymer and engineered to be pulsatile, biostable, torque-resistant and suturable. Once it is implanted, the graft's polymer construction allows it to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex has also been specially formulated to be flexible, enabling CardioPass to pulse like a human vein would as it carries blood to the heart. CardioTech makes polymer materials and manufactures products for the treatment and diagnosis of a range of diseases.
•CryoCor (San Diego) reported the publication of a study on the treatment of atrial fibrillation (AF) using the company's Cryoablation system. The study concluded that, using the Cryoablation system, pulmonary vein isolation benefited 82% of patients with recent onset paroxysmal AF during a mean follow-up averaging 33 months. This is the first and only study to be published that reviews safety and long-term efficacy of AF ablation using cryotherapy, or extreme cold, CryoCor said. The study also demonstrated an excellent safety profile with no occurrences of pulmonary vein stenosis or esophageal injury, which are two serious complications that can occur during AF ablation with radio frequency, or other heat-based, ablation devices. CryoCor makes products for the treatment of cardiac arrhythmias.
•CryoLife (Kennesaw, Georgia) reported implantation of the first CryoValve SG pulmonary human heart valve since the product was cleared by the FDA, performed on a patient at St. Louis Children's Hospital (St. Louis, Missouri). The CryoValve SG is processed with the company's SynerGraft technology, which removes allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. The CryoValve SG is indicated for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves in pediatric and adult patients. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures, commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient's defective aortic valve is removed and replaced with his own pulmonary valve. The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve. CryoLife is a biomaterials, medical device and tissue processing company.
•Edwards Lifesciences (Irvine, California) reported the first three human implants of its transcatheter aortic heart valve. Edwards' balloon-expandable pericardial tissue valve features a cobalt chromium alloy frame that reduces the profile by four to five French. This enables easier access into and within the patient's vasculature for delivery of the valve without open-heart surgery. In this transcatheter replacement procedure, the SAPIEN bovine pericardial valve is compressed onto a balloon to the approximate diameter of a pencil, threaded through the patient's circulatory system from the leg using the RetroFlex transfemoral delivery system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision. The new valve will also be offered in additional sizes. The FDA conditionally approved the investigational device exemption clinical trial in late 2007. The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data in support of a commercial approval application.
• ELA Medical (Denver), a Sorin Group company, reported the FDA's approval to market Isoline, its latest generation of defibrillation leads. ELA said that the Isoline defibrillation leads have a multi-lumen structure with a silicone body and include an ETFE protective coating placed around the cables leading to the electrodes. The Sorin Group makes medical technologies for cardiac surgery.
•Initial results from an international clinical trial of the Left Ventricular Assist System from HeartWare (Framingham, Massachusetts/Sydney, Australia) were presented by Georg Wieselthaler, MD, cardiothoracic surgeon at Vienna General Hospital, at the annual meeting of the International Society for Heart and Lung Transplantation (Addison, Texas) in Boston.The data demonstrated a six-month survival rate of 91% among the first 23 patients implanted with the HeartWare device. Of the 23 patients, 21 met the primary endpoint of the trial, defined as survival to 180 days or transplantation. These included 19 patients who were supported by the HeartWare system at 180 days and two patients who received transplants, after 157 days and 176 days respectively. Wieselthaler said that one of the key features of the pump system is its small size, allowing it to be implanted in the chest and thereby avoiding the abdominal surgery generally required to implant these types of devices. Douglas Godshall, CEO of HeartWare, said the early clinical success "give us great confidence as we move towards the start of our U.S. clinical trial and towards commercial release of the product in Europe."To date a total of 32 patients have been enrolled in HeartWare's international clinical trial, the company reported. The average duration of support across this patient group exceeds 220 days per patient. The cumulative period of support across the group exceeds 7,000 days or roughly 19 years. The current international clinical trial of the HeartWare LVAD is being carried out at five centers in Europe and Australia.
•Masimo (Irvine, California) reported that a new clinical study, recently published in the Journal of Emergency Medicine, found the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter to be "a safe, easily applied tool at triage that can identify cases of unsuspected elevated levels of carbon monoxide (CO) poisoning" otherwise undetected. The research team noted that identification of CO toxicity in the ED is challenging because many patients may not know or suspect that they were exposed to CO and are unable to provide clinicians with sufficient history to prompt testing for carboxyhemoglobin (COHb). In addition, the symptoms of CO poisoning can be similar to the flu. However, missing the opportunity to diagnose CO poisoning at the ED because screening large populations of patients by invasive blood testing for CO toxicity is not practical and not routinely performed in the ED setting can lead to "inadvertently returning a patient to the site of CO exposure and may lead to further toxicity with the possibility of long-term neurological, psychiatric, or cardiovascular complications." Masimo bills itself as the inventor of Pulse CO-Oximetry and Measure-Through-Motion & Low Perfusion Pulse Oximetry.
• MediGuide (Haifa, Israel) and Royal Philips Electronics (Amsterdam, the Netherlands) reported launch of clinical trials in the U.S. using the Philips Integris Allura Flat Detector catheterization lab (Allura FD-10) integrated with MediGuide's Medical Positioning System (gMPS) technology. The trial at Columbia-New York Presbyterian Hospital (New York) is being conducted under an investigational device exemption (IDE) and uses the MediGuide gMP Enabled Guided Measurement Catheter (GMC) with the integrated Philips-MediGuide technologies. The gMPS system and GMC device are CE-mark certified and are limited to investigational use only in the U.S. Philips and MediGuide have been cooperating since 2003 in the field of cardiac navigation. The gMPS system is used for intravascular evaluation of coronary anatomy and is intended to enable real-time tip positioning and navigation of a gMPS-enabled diagnostic or therapeutic device used in coronary or cardiac intervention in the cath lab environment, on both live fluoroscopy or recorded background. The system is indicated for use as an adjunct to coronary angiography. The gMPS-enabled GMC intravascular device is intended to be used in conjunction with conventional X-ray angiography systems to enable real-time tip positioning and navigation, quantitative length measurement, 3-D lumen reconstruction, qualitative 3-D foreshortening indication and landmarking, in patients who are candidates for coronary angiography and/or percutaneous coronary intervention. MediGuide, a company spun off from Elbit Systems, is a provider of technology, solutions and applications for intra body navigation and less-invasive procedures, with a focus on cardiology.
• Omron Healthcare (Kyoto, Japan) reported development of the HEM-Solar series, solar-powered digital blood pressure monitors. There will be two blood pressure monitors for the series, a manual upper-arm and automatic upper-arm model. Both are charged by exposure to sunlight through the solar panel at the back of the product. After four hours of direct exposure to sunlight, the manual model can take more than 100 readings while the automatic model can take 28 readings. The products feature AES (-1) plastic material, which is durable against UV light; an important component given the device's frequent exposure to sunlight. The devices also feature embossed buttons on the front panel to protect against exposure to precipitation. Omron aims to release the products in spring 2009. Omron Healthcare makes medical, home healthcare and wellness products.
•Polymer Technology Group (PTG; Berkeley, California), a biomaterials company, reported that its customer, Sunshine Heart, passed the five-year milestone on durability-testing of its C-Pulse implantable heart assist device. C-Pulse is a non-blood-contacting heart assist therapy for patients with moderate to severe heart failure. C-Pulse includes two polymers from PTG. Sunshine Heart is seeking an Investigational Device Exemption feasibility trial with C-Pulse. "We started with PTG with an exploratory development program, then advanced to a manufacturing program, resulting in a very durable Cuff for the C-Pulse," said Donald Rohrbaugh, CEO of Sunshine Heart. PTG, co-founded in 1989 by Robert Ward, the company's CEO. PTG specializes in R&D and the design, scale-up and manufacture of new polymers, medical devices and components, saying that its portfolio includes two extensively tested biomaterials in clinical use: BioSpan segmented polyurethane and Bionate polycarbonate urethane.
• SynCardia Systems (Boston) reported the introduction of the prototype of its new four-pound Companion II Driver, the next step in its Companion Driver System series. The Companion Drive System is designed to be docked into the Companion Hospital Cart for use in the operating room and intensive care unit. Once the CardioWest artificial heart patient is stable, the Drive Unit is designed to be re-docked into the Companion Discharge Caddy for mobility around the hospital and recovery at home.
•Synthetic Blood International (Costa Mesa, California) said it intends to file a clinical protocol with the FDA for its planned Phase II-b clinical trial of Oxycyte in Traumatic Brain Injury (TBI) patients. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute. The decision to file the protocol was made after the FDA accepted without comment the report on the results of the TBI Phase II-a safety study. Synthetic Blood International makes pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring.
•Toshiba America Medical Systems (TAMS; Tustin, California) has received FDA clearance for two new CT clinical applications designed to improve throughput and enhance workflow, while further reducing contrast and radiation dosage. The applications, SURECardio Prospective and Variable Helical Pitch (vHP), are available for new Toshiba Aquilion 32- and 64-slice CT systems. The SURECardio helps reduce patient dose by up to 80% during coronary CTA exams by using a helical acquisition technique to provide one continuous image instead of multiple images produced by the current step-and-shoot techniques. SURECardio Prospective automates scan parameters and reconstruction based on the patient's heart rate. It also speeds exam time and eliminates the need to use additional contrast as with the step-and-shoot method. Variable Helical Pitch (vHP) increases workflow and efficiency by enabling physicians to complete an exam of more than one anatomical region consecutively i.e. without stopping to alter the helical pitch of the exam. TAMS makes diagnostic imaging systems.
•The U.S. Army Institute of Surgical Research (ISR; San Antonio, Texas) has issued the results of a study showing that WoundStat, a product from TraumaCure (Bethesda, Maryland) is the most effective wound treatment available to stop severe bleeding, the No. 1 cause of death for soldiers in battle. Only WoundStat was 100% effective at stopping high-pressure arterial bleeding in severe wounds, according to the report. WoundStat is a granular mix that comes in a lightweight pouch. WoundStat is non-toxic and TraumaCure says that it has no side effects, such as heat generation, that have plagued other products. It works even in heparinized blood, and is effective in all temperatures. TraumaCure does research concerning ballistic injuries.