Terumo Heart (Ann Arbor, Michigan) moved another step closer in its quest to release its DuraHeart Left Ventricular Assist System on the market, after the Institutional Review Board of the University of Michigan voted in late June to move forward with the device's pivotal trial for a bridge-to-transplant indication.
FDA gave unconditional approval for the trial in March.
The DuraHeart LVAS Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients. It will include up to 40 centers and will last for 2-1/2 years, according to the company.
The DuraHeart LVAS is a third-generation circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure. An LVAS assists the left side of the heart in pumping blood throughout the body.
"Development of the device started in the mid-1990s," Marketing Manager Mark White told Cardiovascular Devices & Drugs. "It works off the principle of centripetal force. The pump itself is shaped like a hockey puck. Fluid enters the center of the pump and flows out in a radial formation."
White said it is the only CE-marked implantable LVAS combining a centrifugal pump with magnetic levitation of the impeller, providing exceptional reliability and minimizing the potential for blood damage and thrombus.
"That's what makes the device unique the magnetic levitation of the impeller this allows the piece of the pump that does the work not to touch the cell. Typically when you use a pump to move blood there are a lot of issues to deal with. You just cannot have a device that ruptures cells."
Here's how it works.
The DuraHeart helps the left ventricle pump oxygenated blood throughout the body. Since a failing heart cannot pump enough blood to the body, the DuraHeart takes over the additional work.
With an implanted DuraHeart LVAS, blood flows from the left ventricle along two paths. Blood flows along its normal route, from the left ventricle directly to the body. At the same time, the DuraHeart Pump assists the heart by pushing blood from the bottom of the left ventricle to the aorta.
DuraHeart consists of seven main parts.
• The primary component is the pump, which is implanted in the abdomen and is about the diameter of a hockey puck.
• The Inflow conduit is a small titanium tube which connects the pump to the heart.
• An outflow conduit comprised of Vaskuteck Gelweave is sewn to the aorta.
• A small controller serves as the brain of DuraHeart and is worn or carried by the patient. It connects to the pump cable and is powered by batteries.
• The batteries provide energy for the pump for a little more than three hours.
• A battery charger provides power to the device and charges it while it remains inactive.
• Finally, there is the hospital console, which allows doctors and hospital staff to monitor and have a degree of control over the pump.
The device is implanted in a preperitoneal pocket in the left upper abdomen. An apical cuff is sutured to the apical hole in the left ventricular apex with 12 mattress sutures of 3-0 Prolene pledgeted with Dacron felt. In the first six mattress sutures, the needle is exited from the apical hole after a full-thickness bite of myocardium, and in six additional mattress sutures, the needle is exited from the epicardial edge of the apical hole. Next, a double purse-string suture with 3-0 Prolene is placed on the Dacron pledgets around the apical hole. After the inflow conduit has been connected to the inlet port of the blood pump, the inflow conduit is secured to the apical cuff. The graft portion of the outflow conduit, which was connected to the blood pump beforehand, is sewn end-to-side to the ascending aorta with a 4-0 Prolene suture. Gentle suture connection of the apical cuff to the left ventricular apex and optimal alignment of the inflow conduit, which is bent by 60 , are crucial in the surgical procedure.
Ultimately Terumo Heart is looking toward getting a designation of permanent use for the device. To accomplish this designation the company plans to have another pivotal trial to be started about a year or so into the current bridge-to-transplant trial.
"We're going to have over 200 patients in (the permanent trial)," White said.
As to when the device might be available on the market with "permanent" labeling, he added that "designation is a little bit harder to peg" than the bridge-to-transplant indication.
Terumo Heart is a business unit of Terumo Medical (Somerset, New Jersey) and develops cardiovascular devices.
Elsewhere in the product pipeline:
• AngioScore (Fremont, California) reported the start of enrollment in the AngioSculpt scoring balloon catheter multi-center coronary bifurcation study, or AGILITY trial. The AGILITY trial will enroll 100 patients with coronary bifurcation lesions at eight premier interventional cardiology programs in the U.S. and follow these patients for nine months. AngioScore says the AngioSculpt scoring balloon catheters represent the next generation in angioplasty catheters for both coronary and peripheral artery disease. Their nitinol elements provide circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding "geographic miss" through their unique anti-slippage properties.
• Astellas Pharma US (Deerfield, Illinois) reported the commercial availability of Lexiscan (regadenoson) injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide MPI a test that detects and characterizes coronary artery disease in patients unable to undergo adequate exercise stress. Lexiscan was designed to produce coronary vasodilation and increase coronary blood flow by activation of the A2A adenosine receptor. Lexiscan is administered as a rapid intravenous injection (about 10 seconds) with no dose adjustment required for body weight. Astellas Pharma US is the U.S. affiliate of Astellas Pharma (Tokyo).
• Biotronik (Berlin, Germany) reported the launch of the Lumax 540 series, which includes implantable cardioverter defibrillators (ICDs) and a cardiac resynchronization therapy defibrillator (CRT-D). Together with Biotronik Home Monitoring, this enables continuous automatic daily data transmission of the patient's cardiovascular status. The information is available to the physicians online allowing them to continuously check their patients' cardiac and device status. The Lumax 540 devices offer the combination of advanced tachycardia therapy management, diagnostic capabilities and remote monitoring technologies that support physicians in creating efficient care pathways for their patients with cardiac devices and further improve patient care.
• Braemar (Minneapolis) has introduced the DL900, a digital Holter monitor. The monitor weighs 1.75 ounces, and has extended recording time of up to seven days. A newly designed, custom analog IC for signal acquisition is the technology platform for the advanced capabilities of the DL900. The device combines high-speed USB transfer capability with the ability to use a removable SD memory card. The DL900 provides high-resolution recordings as well as high sampling rate options suitable for both clinical and research applications. A programmable pacemaker detection capability provides the clinician with additional data.
• Card Guard (Rheinfal, Switzerland), the parent company of LifeWatch (Rosemont, Illinois), said it received FDA clearance for its LifeStar ACT III platinum system. The new 3-lead version offers the same full auto-detect and auto-send device functionality and therefore does not require any patient interaction. The LifeStar ACT system can automatically detect and send heart rhythm abnormalities to a LifeWatch monitoring call center that is staffed 24/7 by specialized cardiac technicians who can immediately interpret the data and initiate any necessary next steps.
• Cardiac Science (Bothell, Washington) reported the launch of Pyramis 6.2, the HeartCentrix data management product for the hospital market. The company said Pyramis 6.2 centralizes diagnostic cardiology data for rapid access across all facilities within a hospital network. Pyramis supports hospitals' preferred ECG devices, stress testing equipment, Holter monitors and other devices on a single platform and provides bi-directional communication when paired with most Quinton and Burdick devices. Separately, Cardiac Science said it had completed certification for its HeartCentrix ECG informatics software with the Allscripts Electronic Health Record (EHR). The connectivity between Cardiac Science's equipment and the Allscripts EHR will help physicians streamline the diagnostic cardiology workflow in their offices, eliminate a source of data transcription errors, and provide a unified view of patient diagnostic data. With HeartCentrix ECG informatics, physicians will have immediate access to view or edit a patient's test results electronically and later retrieve the data from the Electronic Health Record.
• Cardiogenesis (Irvine, California) reported an upcoming scientific presentation that describes the use of combining transmyocardial revascularization (TMR) with platelet rich plasma (PRP). The presentation titled "Intramyocardial Injection of Autologous Platelet Rich Plasma combined with Transmyocardial Revascularization" will be presented at the 34th annual meeting of the Western Thoracic Surgical Association. The study involves a group of consecutive patients treated with the Cardiogenesis holmium: YAG Laser TMR System. The authors conclude, "These preliminary results suggest that combining intramyocardial injection of PRP with TMR may be more efficacious at relieving angina and improving myocardial function than TMR alone." Cardiogenesis' holmium: YAG laser system and disposable fiber-optic accessories are used to perform a surgical procedure known as transmyocardial revascularization to treat patients suffering from angina.
• Cook Medical (Bloomington, Indiana) reported the first human use of its Zenith low-profile AAA endograft system. The Zenith Low Profile AAA Endograft System addresses those areas of concern by reducing the size of the delivery sheath to 16 Fr. This development, if proven safe and effective in an upcoming clinical trial, could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues. In addition, it may enable physicians to eliminate the need for a surgical cut down to access the femoral artery and allow the use of the percutaneous entry technique where a needle is inserted to allow the guidewire and delivery sheath to enter the artery with far less trauma.
• CryoCath Technologies (Montreal) reported the introduction of Arctic Front in Hong Kong. Arctic Front, the company's lead product for the treatment of paroxysmal atrial fibrillation (PAF), is a cryoablation balloon catheter that allows physicians to isolate all four pulmonary veins in the treatment of PAF. Arctic Front is a minimally invasive bi-directional, double-ballon cryo-balloon catheter designed specifically to treat PAF.
• The first available two-year data from the European clinical trial evaluating the Rheos Hypertension (HT) system were presented at Hypertension Berlin 2008. Made by CVRx (Minneapolis), the implantable Rheos HT system is designed to control hypertension. The Rheos HT system uses CVRx Baroreflex Activation Therapy technology, which is designed to electrically activate the carotid baroceptors, the body's natural blood pressure sensors. When the baroreceptors are activated, signals are sent through neural pathways to the brain and interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by sending signals to other parts of the body (heart, blood vessels and kidneys) to lower high blood pressure. The Rheos HT includes a small pulse generator that is implanted under the collarbone; two thin lead wires that are implanted at the left and right carotid arteries and connect to the pulse generator; and the Rheos programmer system, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.
• Isotechnika (Edmonton, Alberta) said that voclosporin is positioned to enter a Phase I clinical trial as the drug used in the Cinatra drug-coated coronary stent system developed by the company's partner, Atrium Medical. The Cinatra voclosporin coated coronary stent system is made of a cobalt chromium bare metal stent mounted on a delivery balloon catheter. The stent and the balloon are coated with Atrium's Omega-3 fatty acid coating technology, using voclosporin for its anti-inflammatory properties.
• Medtronic (Minneapolis) reported FDA ap-proval for the Talent thoracic stent graft, a device for the minimally invasive treatment of certain types of aneurysms of the descending thoracic aorta. "There are still many patients undiagnosed and in need of treatment for thoracic aortic disease," said Ronald Fairman, MD, professor of surgery and chief of vascular surgery at the University of Pennsylvania Hospital (Philadelphia). "FDA approval of the Talent Thoracic Stent Graft is an important development in physicians' abilities to treat this life-threatening condition. In my experience, this device offers a superior alternative to open surgery and will allow physicians to perform minimally-invasive thoracic aortic aneurysm repair for a broader population of patients." The Talent makes thoracic endovascular aortic repair accessible to an additional 25% of patients. It is available in a range of diameters from 22 mm to 46 mm.