CardioGenesis (Foothill Ranch, California) said it will continue to pursue approval for its percutaneous transmyocardial revascularization treatment (PTMR) for angina, or PMR, following an FDA panel's vote against recommending the treatment system. The Circulatory Device Systems Panel of the Center for Devices and Radiological Health on July 16, voted 7-2 against recommending the company's Axcis laser system for reducing the symptoms of angina, and the company said it "will work closely" with the FDA to gain marketing clearance "while aggressively continuing ... focus on the growth of TMR." In heavy Nasdaq trading following the panel's decision, the company's share priced dropped by more than two-thirds, falling below the $1-per-share level. Michael Quinn, chairman and CEO of CardioGenesis, expressed disappointment with the decision – which was based primarily on concerns over the company's data regarding adverse events – but said he "appreciated [the panel's] guidance on where to focus the company's efforts." He noted that the panel had acknowledged the treatment's ability to relieve angina pain and that the system, "once approved, will become a widely used and effective procedure." Additionally, he said that the company will increase its marketing efforts for the treatment in Europe and Asia, where the system already has been approved. Quinn added about the panel vote: "We intend to add complementary products for the treatment of cardiovascular disease that fit well into our distribution model, and we expect to expand our offerings, both domestically and internationally."
Elsewhere in the product pipeline:
Acuson (Seattle, Washington), a Siemens company, said it has added new technological features for the KinetDx Solutions Network. Key features of the KinetDx Total Viewer system enable physicians and sonographers to automatically transfer cardiac calculations data from the Sequoia Echocardiography system to the KinetDx DS3000 or the CWS3000, eliminating time spent writing up worksheets and improving the turn-around of final reports. According to Acuson, the system upgrade expands the capabilities in cardiac imaging through the automatic transfer of cardiac calculations data from the Sequoia or Aspen echocardiography systems to the KinetDx worksheet and report package. This feature will eliminate the time a sonographer spends manually creating worksheets for physicians, and it will increase the accuracy of final reports. In addition to echocardiograms, the system makes it possible for physicians to pre-fetch and view cardiac angiography, computed tomography and magnetic resonance images, which expands the multi-modality capabilities of KinetDx in both cardiology and general imaging, the company said. The angiography viewer allows cardiologists to view cardiac catheterization images and compare them with the ultrasound images commonly taken before and after catheterization.
Boston Scientific (Natick, Massachusetts) said it has begun enrollment in its international TAXUS II drug-eluting stent clinical trial led by principal investigator Antonio Colombo, MD, of EMO Centro Cuore Colombus (Milan, Italy). The TAXUS program is a series of studies aimed at collecting clinical information on Boston Scientific's paclitaxel drug-eluting stent technology for reducing coronary restenosis, the regrowth of vascular tissue within an artery after angioplasty and stenting. The company said that Paclitaxel, the active component of the popular chemotherapeutic agent Taxol, has demonstrated promising results in preclinical studies for reducing the processes leading to restenosis. The stent is designed to provide direct delivery of paclitaxel through a polymer on a stent at the desired location with a very predictable and controlled release to prevent restenosis. TAXUS II is a 532-patient, multicenter, international study where patients are randomized to receive either a paclitaxel-eluting stent or a bare, stainless steel control stent. In addition to monitoring clinical outcomes, intravascular ultrasound (IVUS) will be used to study safety and performance of two separate dose releases of paclitaxel. Boston Scientific has acquired worldwide co-exclusive rights from Angiotech Pharmaceuticals (Vancouver, British Columbia) to use paclitaxel to coat its coronary stent products and other vascular and non-vascular products. Angiotech develops medical coatings and treatments for chronic inflammatory diseases.
CardioDynamics International (San Diego, California) has submitted a 510(k) application to the FDA for its new remote monitoring system, the BioZ dTEL which uses noninvasive ICG technology and allows data to be transmitted to physician offices, via the Internet. The DiTEC clinical program is designed to assist nephrologists by enhancing cardiac evaluation and disease management activity of the patient in the dialysis setting, thereby, augmenting the overall cardiac care provided by the treating nephrologists. Michael Perry, CardioDynamics CEO, said, "We are committed to the development of Internet-based ICG devices, and discussions are in progress with leading medical monitoring companies for inclusion of our proprietary technology into their product offerings." CardioDynamics' primary products, the BioZ Systems, use proprietary BioZ Impedance Cardiography (ICG) technology to noninvasively provide hemodynamic data not previously available in the physician's office and many hospital settings.
Computer Motion (Santa Barbara, California) released the latest version of its Zeus system, using MicroWrist technology. With this new version, the company said, surgeons can familiar open surgery movements, while performing endoscopic procedures through tiny 5 mm ports. The 46 Zeus systems currently in use worldwide can be upgraded to the MicroWrist technology. The company expects the majority of its current customers to upgrade. The cost of upgrading is anticipated to be less than $200,000 per system. According to Computer Motion, Zeus with MicroWrist provides a fundamental change in surgeon ease of use and system functionality while maintaining the previous advantages of the Zeus product platform. Features of the device include a 5 mm articulating wrist instruments that mimic open-surgery movements in endoscopic procedures; an open platform design that supports integration of complementary technologies such as 3-D visualization and bi-polar/ultrasonic devices; a small system size; and lightweight, modular arms for easy setup, flexible positioning, rapid disassembly and portability. Current plans call for a 3Q01 product launch.
Cook (Bloomington, Indiana) has initiated a U.S. clinical trial of its coronary stent coated with the anti-cancer drug paclitaxel. The company reported that the first patient with was recently implanted with its Logic PTC Coronary Stent at the Elyria Regional Medical Center (Elyria, Ohio), marking the beginning of the study's enrollment. Cook has developed a proprietary, polymer-free technology to coat coronary stents with paclitaxel to inhibit restenosis, or the reclosing of a stented artery. Paclitaxel, which Cook licensed from Angiotech Pharmaceuticals, is thought to prevent excessive cell regrowth at the site of the angioplasty, thus reducing or eliminating restenosis. During the manufacturing process, the metal body of the stent is coated with a small quantity of the drug. Then, after placement of the stent, the paclitaxel is gradually released into the cells of the arterial wall. Cook recently completed patient enrollment in its Asian- and European-based clinical trials of paclitaxel-coated stents. The FDA has approved Cook for a U.S. trial consisting of five centers and 50 patients, which began with the procedure in Elyria, but the company anticipates enrolling as many as 800 patients in 30 to 50 centers, with enrollment wrapping up sometime in early 2002. The study group will receive a one-dose coated Logic stent, with the control group receiving a Logic stent that is uncoated. Cook was the first manufacturer to introduce coronary stents to the U.S. in 1993.
CryoCor (San Diego, California) reported the expansion of its clinical trial to treat heart arrhythmias with additional clinical procedures being performed by physicians at the Academic Hospital Maastricht (Maastricht, the Netherlands). The CryoCor Cardiac Cryoablation System uses intracardiac cryotherapy to treat patients with rapid and irregular heartbeats, including atrial fibrillation. The system delivers refrigerant to the tip of an intravascular catheter. Once positioned inside the heart, the catheter can produce temperatures below -80 degrees Celsius to selectively inactivate the arrhythmia-inducing tissue and thereby prevent rapid and irregular heart rhythms. The company said that the team of physicians at the Academic Hospital Maastricht used the Cardiac Cryoablation System to successfully treat their first patient, a 45-year old man suffering from both atrial fibrillation and atrial flutter. After completing this initial clinical trial, which currently is being performed in The Netherlands, Hong Kong and Germany, CryoCor said it plans to apply for a CE mark that will allow CryoCor to market the Cardiac Cryoablation System in Europe. The company said it also is planning to submit a request to the FDA that will allow it to conduct similar human clinical trials for cardiac arrhythmias in the U.S.
Guidant (Indianapolis, Minnesota) reported the European release of its Contak Renewal device for heart failure treatment. The Renewal cardiac resynchronization therapy defibrillator (CRT-D) was designed to address two critical issues in treating heart failure, the company said, quality of life and risk of sudden cardiac death (SCD). The device monitors heart rate variability, a tool designed to track and measure the status of heart failure patients. Renewal also uses data from an accelerometer sensor to track trends in a patient's activity level. Renewal CRT-D products use independent electrical stimulation to the left and right ventricles to address dyssynchrony in cardiac contractions. SCD often occurs due to extremely fast ventricular arrythmias. To prevent that, Renewal uses Guidant's Ventak Prism implantable defibrillator. The company said that the first implants of the Contak Renewal 2 have taken place, led by investigators at the German Heart Institute (Berlin, Germany). So far, there have been 10 implants as part of the Guidant clinical protocol to evaluate performance via post market studies. The Renewal 2 CRT-D's new features include: Heart Failure Expert Ease, an automatic feature that allows the physician to optimize a patients cardiac resynchronization therapy by providing suggested setting for programming the device; the LV (Left Ventricle) Offset to adjust the timing of the stimulation to optimize ventricular contraction; and Biventricular Trigger for the synchronous ventricular contractions for patients with atrial arrhythmias.
Jomed NV (Ulestraten, the Netherlands) a European developer of products for minimally invasive vascular intervention said that the FOX, a PTA catheter, has been cleared by the FDA for marketing in the U.S. PTA catheters are used to open up non-coronary arteries and place stents in a minimally invasive fashion. The company said it expects to launch the FOX in the U.S. toward the end of the year.
MedAmicus (Plymouth, Minnesota) has received 510(k) clearance from the FDA to market its center-line retractable Guidewire Introducer Safety Needle, a product licensed from and co-developed with Med-Design (Ventura, California). Mark Kraus, vice president and general manager, said the device also meets the guidelines of the Needlestick Safety and Prevention Act, which went into effect. Kraus said he expects market launch of the product in 3Q01. MedAmicus makes percutaneous delivery systems. Its products include venous vessel introducers, safety needles and other disposable delivery products for use in the implantation of pacemakers, defibrillators, catheters and infusion ports sold through OEM relationships with other medical device companies. Med-Design develops safety needle devices covering applications within the areas of blood collection, infusion therapy, insertion and injection.
Pulse Metric (San Diego, California) has launched what it said is believed to be the first FDA-cleared hemodynamic monitoring device. The device, called the DynaPulse Pathway, is a standard blood pressure monitoring system that also provides a hemodynamic information for the evaluation of cardiac function. The system has been designed to provide clinicians with a comprehensive assessment of the patient's cardiac function during the course of a routine blood pressure measurement. The DynaPulse Pathway system uses a simple upper-arm cuff to measure blood pressure values (systolic, diastolic and mean arterial pressure) and heart rate. Using proprietary patented technology, the system also is able to calculate other critical hemodynamic parameters, including cardiac output, systemic vascular resistance, left ventricular contractility, left ventricular dP/dt, and arterial compliance/distensibility. "The company received FDA clearance on the basic device that measures blood pressure and measures waveforms about seven years ago," said Allen Ruzkowski, senior vice president of Pulse Metric. "We received 510(k) clearance for measuring arterial compliance (the flexibility of arteries) in October 2000. Additionally, we were given clearance to measure cardiac output – the volume of blood that the heart ejects in liters per minute – in January of this year." He added that this last clearance allows a physician using the device to calculate systemic flow of blood. The device is connected to a PC in a doctor's office or in the home and the pulse wave-shaped data that are generated are sent over the Internet to the company's servers where the algorithms are processed. The data can also be trended over time to reveal a patient's medical history. Ruzkowski said the device might prove especially valuable to patients with congestive heart failure.
Response Biomedical (Vancouver, British Columbia) has filed regulatory submissions with the FDA and the Canadian Therapeutic Products Directorate for market clearance of both its RAMP Reader and the first RAMP whole blood test. The RAMP System is designed to deliver laboratory comparable results in 10 minutes. The first test for which Response is seeking clearance is for myoglobin, a cardiac marker that is measured to assist in the diagnosis of a heart attack. The company said that testing with RAMP could provide doctors with the information needed to diagnose and treat heart attack patients before irreversible heart damage or death occurs. Rapid diagnosis reduces costs associated with unnecessary hospital admissions. RAMP also can aid in reducing the number of patients who are undiagnosed and have subsequent heart attacks, according to the company. In addition to myoglobin, tests are being developed by Response for two other common cardiac markers: CK-MB and troponin I. As a group, these markers are effective as aids in the diagnosis of heart attacks, provided that test results are received in a timely manner.
Scios (Sunnyvale, California) received an approvable letter from the FDA for Natrecor as an intravenous treatment for patients with acutely decompensated congestive heart failure. The company said the FDA is prepared to approve the new drug application following the finalization of Natrecor labeling and completion of a pre-approval inspection. The FDA's Cardiovascular and Renal Drugs Advisory Committee unanimously recommended approval of Natrecor in May. If approved, the company said, Natrecor will become the first new treatment for acutely decompensated cardiovascular heart failure in more than a decade. Natrecor is a recombinant form of B-type natriuretic peptide.
St. Jude Medical (St. Paul, Minnesota) reported that surgeons at Evanston Northwestern Healthcare (Evanston, Illinois) performed open-heart surgery using a connecting technology that replaces the traditional suture in the procedure. The FDA approved the new device, the St. Jude Medical Symmetry Bypass System Aortic Connector, this past May, and since June 1, surgeons have used the aortic connector in 15 coronary artery bypass graft procedures. The connector enables surgeons to perform a minimally invasive, "no touch" coronary bypass graft surgery on a beating heart. The new aortic connector allows surgeons to attach vein grafts to the aorta with a star-shaped rivet, a mechanical procedure taking less than 10 seconds vs. three to five minutes to sew the connection by hand. St. Jude also received FDA premarket approval of its Livewire TC Compass, an advanced mapping and ablation electrophysiology catheter that can assist clinicians in clinical management of supraventricular tachycardias (SVTs), including atrial fibrillation (AF). The system is designed to locate the focal triggers of heart arrhythmias responsible for initiating SVTs, including atrial fibrillation. The catheter system also features ablation capabilities for the RF ablation of selected SVTs, including Wolff-Parkinson-White syndrome, atrioventricular nodal reentrant tachycardia and atrioventricular node ablation, the company said. U.S. market release is planned for 3Q01. According to St. Jude, the new system represents a "significant advance in mapping technology for paroxysmal atrial fibrillation PAF, since a single catheter can provide bipolar, unipolar and vector mapping capabilities, all without the need for expensive capital equipment systems."