CardioVention (Santa Clara, California) last month received FDA 510(k) clearance for an improved version of the traditional heart-and-lung machine that is the workhorse of the cardiac surgery arena. The company received 510(k) clearance from the FDA and already has CE mark approval to market the CORx System in Europe for use in cardiac surgery. The CORx has been designed to replace traditional heart-lung bypass systems and already has been used for a variety of cardiac surgical procedures, including stopped-heart and perfusion-assisted beating-heart surgery, coronary artery bypass-grafting, atrial septal defect and aortic valve replacement.
CardioVention said the machine will minimize the need for blood transfusions, reduce a patient's length of stay in a hospital, reduce inflammation and potentially reduce neurological complications. The company said more than 1.2 million cardiac surgery procedures are performed worldwide annually, resulting in a $1 billion market for cardiovascular surgical products. Of these procedures, 85% of patients are placed on heart-lung bypass, also known as cardiopulmonary bypass (CPB).
Ben Bobo, vice president of marketing and business management at CardioVention, said the device, which is about the size of a beverage can, is the first real advance in CPB technology in nearly three decades. "In the past 30 years, there really hasn't been any change in cardiopulmonary bypass," he told Cardiovascular Device Upate's sister publication, Medical Device Daily. Traditional heart-lung bypass machines require a patient to be connected up to a large cardio bypass circuit that requires 1,500 to 2,000 ml of priming volume just to get a patient connected. Bobo noted that the body attempts to maintain an equilibrium, and when that large of a volume of blood is passing through patient's system, it has to go somewhere. Thus, much of the excess blood is forced to the cellular level, which can cause swelling via pulmonary edema, as well as neurological complications. "If you look at people after they come out of the ER after going on pump, they look like tomatoes – they look swollen."
Heart-lung bypass machines require blood to move across about 14 square meters of surface area as it flows through the machine. Additionally, vital cells, such as platelets, may become trapped in the machine. Because of that, the patient may also require large amounts of extra blood to replace the lost cells and the weakened blood may hinder the healing process.
The CORx is a much smaller system. It only requires that that the blood travel across 1.4 square meters of surface area before entering the body. In addition, less than 500 ml of fluid are required to prime the system, allowing the use of the patient's own blood for priming as opposed to the solution often used. This results in minimal to no hemodilution (increase of the fluid content of blood) to the patient.
From the physician's point of view, the system is a potential godsend. Studies have indicated that the CORx may bridge the gap between the surgeon's choice of either stopped-heart surgery or beating-heart surgery. "The encouraging results indicate the system is not only beneficial for the patient, but also the surgeon," said Mehmet Oz, MD, director of the Cardiovascular Institute of New York Presbyterian at Columbia-Presbyterian Medical Center and associate professor of surgery at the College of Physicians and Surgeons of Columbia University (all New York). In the past, he explained, the surgeon had to choose between using a heart-lung machine to perform stopped-heart surgery or eliminate the effects of the heart-lung machine by keeping the heart beating. "Either way, there was a compromise. Now the surgeon no longer has to make that difficult choice because the CORx system provides the best of both worlds."
Valavanur Subramanian, MD, director of the department of surgery at Lenox Hill Hospital (also New York), said, "Oftentimes during beating-heart surgery, as the surgeon accesses the various vessels of the heart, instability of the heart and circulatory system can occur." With the support of the CORx system, he said, "the patient's hemodynamics are stable, allowing the surgeon to focus on the surgical procedure. As a result, the CORx could potentially increase the number of cardiac surgeries done on a perfusion-assisted beating heart."
The CORx system costs just under $60,000 for the equipment and $1,200 for the disposable items used during each surgery.
Elsewhere in the product pipeline:
Bacchus Vascular (Santa Clara, California) reported FDA approval of an investigational device exemption for its Fino system for the treatment of deep vein thrombosis, which occurs when blood clots form in the deep blood vessels of the legs. These blood clots can block flow from the legs back to the heart and lungs, with clots sometimes traveling to the lungs, which can be fatal. Fino is a minimally invasive device designed to remove blood clots from peripheral veins by enabling rapid disruption and removal of deep vein thrombus. Physicians have already used Fino to successfully treat patients in Europe, Australia and Argentina. Bacchus Vascular is focused on treatments for cardiovascular and peripheral vascular occlusive disease.
Biotronik (Lake Oswego, Oregon) received FDA clearance for its Philos DR-T Pacemaker with home monitoring technology. With the home monitoring system, the Philos DR-T automatically transmits critical data about the patient's condition to the physician's office. The system provides three types of data reports: Scheduled, event and patient-triggered. While data is collected daily, physicians have the option to determine how frequently they want to receive a comprehensive cardio report. Scheduled reports can be sent weekly, biweekly or monthly to show data trends and system status information providing additional information at routine follow-up. Event-triggered reports are sent immediately to physicians when an event such as non-sustained ventricular tachycardia occurs, allowing early detection and intervention.
Cardiac Science (Irvine, California) was granted two additional U.S. patents and a European patent covering technology embodied in its Powerheart Automatic External Defibrillator (AED), its Powerheart CRM and its wearable defibrillator product. The U.S. patents cover an AED battery status indicator and the remote collection of information from a wearable defibrillator, while the European patent extends the protection of the company's biphasic energy waveform. Cardiac Science has filed approximately 10 additional patents, which are pending, related to its technology platform and applications in both hospital and public access defibrillator products. Cardiac Science develops portable public access defibrillators and the only FDA-cleared therapeutic patient monitor that automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms.
CardioFocus (Norton, Massachusetts) received 510(k) clearance from the FDA to market its diode laser for use in surgery with the accompanying Optimaze surgical ablation handpiece, previously FDA-cleared for use on cardiac tissue. Together, the laser and handpiece are used to create rapid and precise lesions in the heart during cardiac surgery. The Optimaze Surgical Ablation System will be marketed worldwide by Edwards Lifesciences (Irvine, California). The Optimaze system creates lesions in the heart with a less-invasive and less time-consuming approach, using a malleable laser tip that can be shaped by the surgeon to create precise lesions in virtually any configuration. These transmural lesions can be created in cardiac tissue in less than a minute. Preclinical studies showed that the Optimaze system created 100% transmural lesions in 67 cases. CardioFocus is developing catheter and surgical products for the treatment of cardiovascular disease using diffuse photonic energy.
CryoCath Technologies (Montreal, Quebec) said its SurgiFrost cryosurgical probe to treat cardiac arrhythmias was used successfully on the first five patients in Italy, with worldwide rollout expected by next month. SurgiFrost is a malleable, single-use cryosurgical probe developed to treat cardiac arrhythmias, including atrial fibrillation (AF). The company said surgeons believe that it is appropriate to treat a patient's AF as a secondary outcome while the patient is being primarily treated for mitral valve disease or coronary vessel obstruction. CryoCath said SurgiFrost "augments our portfolio of therapeutic tools to treat AF, and it will mark our first foray into the U.S. market, providing the company with a beachhead to build a marketing and sales infrastructure to support the anticipated 2003 U.S. launch of our Freezor Cardiac CryoAblation Catheter System to treat cardiac arrhythmias." CryoCath creates cryotherapy products to treat cardiovascular disease across three broad indications – tachyarrhythmia, ischemia and restenosis.
Diomed (Andover, Massachusetts) released its EndoVenous Laser Treatment (EVLT) at last month's Society of Cardiovascular and Interventional Radiology meeting in Baltimore, Maryland. Diomed provides clinical modalities and develops equipment and disposable items used in minimal and micro-invasive medical procedures.
Jomed (Beringen, Switzerland) filed a premarket approval shell for modular review with the FDA of its major stent product line, the Jostent FlexMaster, a coronary stent sold in more than 70 countries. The PMA is intended to lead to approval of the Jostent FlexMaster for small-vessel stenting, a growing indication in stent therapy. The company said it believes the Jostent FlexMaster will provide a platform for bringing new technologies and adding significant value and advantages to interventional procedures. For example, the Josonics concept integrates intravascular ultrasound and visualization into the stent delivery system, improving a physician's capability of placing and sizing the implant correctly. The company said it expects a U.S. launch of the Jostent FlexMaster in the first half of next year.
Medtronic (Minneapolis, Minnesota) reported beginning enrollment for its De Novo and Restenotic Registry clinical trial, designed to determine the safety and efficacy of its new Driver Coronary Stent System, formerly known as the S8. The Driver coronary stent system builds on its S7 platform, which the company considers "one of our most successful coronary stents." The study, designed to show the safety and efficacy of the Driver stent system in treating de novo and restenotic lesions in coronary vessels with a diameter of 3.0 mm to 4.0 mm, will enroll approximately 300 patients at 20 U.S. sites. Six-month angiographic data will be collected from the first 100 patients enrolled in the study. The stent is made of a cobalt-based alloy that is designed to be stronger and denser than the conventional stainless steel used in other stents. This new alloy also is designed to allow for thinner struts, resulting in a lower profile and better deliverability without compromising radial strength and visibility. Medtronic also reported the first implant of the InSync Marquis system, the company's fourth-generation heart failure device and its second to treat patients who also need the protection of an implantable defibrillator. The InSync Marquis was implanted in a 65-year-old man in Linz, Austria. Additional implants of the InSync Marquis as part of clinical trials also have occurred in Sweden and Italy. The InSync Marquis provides cardiac resynchronization therapy (CRT) plus advanced defibrillation capabilities for patients at risk of potentially lethal tachyarrhythmias that may lead to sudden cardiac arrest. The Marquis DR ICD received FDA approval March 1. Based on the Marquis DR platform, the InSync Marquis is 38 cc in size with 30 joules of delivered energy, and charge times of less than 7.5 seconds throughout the service life of the device.
Medwave (St. Paul, Minnesota) reported presentation of an abstract at the International Anesthesia Research Society meeting, highlighting the ability of the company's Vasotrac device to accurately reflect cardiovascular changes from its waveform. The abstract showed how the waveform provided by the Vasotrac monitor displayed measurable changes in the values for blood pressure as well as for the systolic cardiac function. In addition, the waveforms produced by the Vasotrac were similar in morphology to those obtained by invasive arterial catheter placements. Medwave's Vasotrac APM205A is designed for measuring a patient's blood pressure non-invasively on a continual basis, with updates available approximately every 15 heartbeats. The system is being used in anesthesiology, critical care, emergency rooms, sleep study labs and cardiology departments in various markets, including the U.S.
Meridian Medical Technologies (Columbia, Maryland) reported results of a multicenter clinical study with its Prime ECG electrocardiac mapping system at the annual meeting of the American College of Cardiology in March, demonstrating the superiority of the new device in the early diagnosis of heart attacks that are frequently missed by conventional ECG systems. Meridian recently received FDA clearance to market the Prime ECG system. The new study measured the Prime ECG system's ability to detect acute ST-elevation MI (STEMI), compared to a traditional 12-lead ECG system in a multicenter trial involving 647 patients with chest pain. Investigators found that Prime achieved a sensitivity of 93% for STEMI, a 63% improvement over a sensitivity of 57% percent with the 12-lead ECG. Specificity was 95% for both systems. Positive troponin tests were used as the gold standard for comparison.
Scios (Sunnyvale, California) reported that its Natrecor (nesiritide) drug for people with severe congestive heart failure provides patients with early relief and gives physicians additional treatment choices, according to Cleveland Clinic research. Published in the Journal of the American Medical Association, the study showed that Nesiritide, approved last year by the FDA, was more effective than intravenous nitroglycerin when used in addition to standard treatment for congestive heart failure. The trial, Vasodilation in the Management of Acute CHF (VMAC involved 489 patients, was completed in 55 hospitals between October 1999 and July 2000. Intravenous nesiritide was compared with intravenous nitroglycerin and a placebo. Changes tracked were dsypnea, or shortness of breath, and pulmonary capillary wedge pressure (PCWP). Clinicians found the reduction in PCWP was significantly greater in the nesiritide group than in nitroglycerin or placebo groups. Patients who received nesiritide also reported feeling less breathless, while 4% of the patients who received nesiritide had hypotension, or low blood pressure, compared with 5% of the nitroglycerin group. The company said clinicians concluded the research suggests that using nesiritide might reduce the need to use inotropes to treat people with acutely decompensated CHF.
St. Jude Medical (St. Paul, Minnesota) released the Ultimum family of hemostasis introducers, combining proprietary materials and manufacturing processes to provide insertion performance into the vasculature. The introducer also features a more versatile valve, enabling it to be used in a wider range of clinical procedures. Ultimum introducers were designed to provide minimal risk of vessel access complications, even in patients with scar tissue, a rapidly growing population of patients. St. Jude said the introducers feature a dual-layer sheath cannula and new dilator configuration. The company said the new valve design provides "optimal catheter feel and maneuverability – while maintaining hemostasis – on guidewires as small as .014 inches," which allows the Ultimum introducer platform to be used in both cardiology and endovascular procedures. In other news, St. Jude received premarket approval from the FDA for its Riata family of defibrillation leads, which the company calls "the world's thinnest, most advanced implantable cardioverter defibrillator (ICD) leads." Available in both active and passive fixation models, the Riata lead is the most recent addition to St. Jude's line of ICD products. Full U.S. commercial release of the Riata lead family is anticipated next month. The Riata defibrillation lead couples an ultra-thin lead body for improved handling and implantation characteristics with a multi-cable design for increased strength and durability.
TransVascular (Menlo Park, California), a developer of products to treat coronary and peripheral vascular disease and congestive heart failure, received 510(k) clearance from the FDA to market its CrossPoint TransAccess catheter. The CrossPoint is a dual lumen catheter designed to facilitate the placement of catheters within the peripheral vasculature. TransVascular noted that peripheral vascular disease is often characterized by extremely long blockages in the arteries in the leg, particularly the superficial femoral artery. Interventionalists must successfully cross the blockage with a guide wire before performing balloon angioplasty and stenting to open the blockage and reduce the likelihood of subsequent re-blockage. The company said the CrossPoint catheter is designed to facilitate the return of the guide wire to the true lumen of the vessel beyond the blockage, allowing the interventionalist to proceed with the intended angioplasty and stenting of the blocked artery.