Guidant (Indianapolis, Indiana) has given international launch to several products that further expand its position in the minimally invasive cardiac surgery (MICS) market. These products include Guidant's next-generation, off-pump, beating-heart-bypass system and the Vortex, its first vacuum-assist stabilization system. With the launch, Guidant said it is the first medical device company "to offer both vacuum-assisted and mechanical methods of stabilization." The Vortex Stabilization System uses vacuum-assist technology, which enables the physician to immobilize the artery while performing beating-heart bypass. It features a stabilizer foot that gently captures the tissue, providing stabilization at low vacuum settings to minimize tissue trauma.
Ulrich Hake, MD, professor of cardiac surgery at the University of Mainz (Mainz, Germany), called the new system "a leap forward in stabilization technology. Tissue trauma associated with the Vortex Stabilization System appears to be significantly reduced compared to other commercially available vacuum-assist devices."
Approximately 350,000 CABG procedures were performed in the U.S. in 1999, with an estimated 15% to 20% of those of the beating-heart variety, according to company estimates.
Guidant features the off-pump technique developed by CardioThoracic Systems (Cupertino, California) purchased by Guidant in November 1999. The new products are the first MICS instruments to be launched by Guidant since that acquisition and add 10 new offerings to its product line.
Additionally, the company in late January received FDA approval to market what it calls "the world's smallest dual-chamber implantable defibrillator," the Ventak Prizm automatic implantable cardioverter defibrillator (AICD) system. "Defibrillator size, shape, longevity and ease of use are preeminent among the standards against which defibrillators are measured by our physician customers. The Ventak Prizm system excels in all four dimensions," said Jay Graf, president of Guidant's Cardiac Rhythm Management Group (St. Paul, Minnesota).
Guidant cited three "critical" characteristics of the Ventak Prizm AICD: Its small, physiologic shape; 39 cc volume, with an oval shape for ease of implant and patient acceptance; longevity which exceeds that of comparably sized devices by a factor of years, increasing the time between device replacement surgeries; and ease of use due to what Guidant called "a significant advance in user interface simplicity" with its Consult software.
Elsewhere in the product pipeline:
Baxter Healthcare's (Deerfield, Illinois) CardioVascular Group, located in Irvine, California, has launched AVA 3Xi, which it calls "the first advanced venous access device flexible enough for routine cardiac care and surgeries." AVA 3Xi features a multifunctional design for various venous access requirements in a single device by transitioning from a multi-lumen introducer to a triple lumen device with a detachable introducer valve. The multiple infusion lumens enable the clinician to administer multiple medications and fluids while requiring only one insertion site, thus eliminating introducer/triple lumen device change-outs, minimizing pain and discomfort, and reducing the risk of complications and infection. The device was debuted in February at the Society of Critical Care Medicine's 29th educational and scientific symposium in Orlando, Florida.
The investigational oxygen therapeutic Hemopure (hemoglobin glutamer-250 [bovine]) or HBOC-201, produced by Biopure (Cambridge, Massachusetts), has been shown to eliminate allogeneic red blood cell transfusions in a significant number of patients undergoing vascular surgery, according to clinical trial results recently published in the Journal of Vascular Surgery. Phase II study results showed the product well tolerated in a patient population consisting largely of elderly patients with complex medical conditions. Results showed that Hemopure totally eliminated the need for red blood cell transfusions in 27% of patients throughout the entire 28-day follow-up period. Moreover, 39% of Hemopure patients required no allogeneic blood during the 96-hour treatment period and 66% required no allogeneic blood on the day of surgery, further supporting the product's use as an oxygen bridge.
Cardiac Science (Irvine, California) has received FDA 510(k) clearance for the commercial version of its Powerheart ECD, a bedside defibrillator that continuously monitors in-hospital patients at risk of sudden cardiac arrest. After the completion and validation of modifications made to the initial model Powerheart, the company filed for special 510(k) clearance for its commercial version in October 1999. The instrument instantly detects the onset of a life-threatening tachyarrhythmia and, when appropriate, automatically delivers defibrillation. Results from a multicenter study published in the February 1999 issue of Pacing and Clinical Electrophysiology concluded that the Powerheart improves both mortality and morbidity associated with in-hospital cardiac arrest.
CardioDynamics International (San Diego, California) reported the results of four BioZ studies presented at the Society of Critical Care Medicine meeting. Two studies demonstrated that the BioZ improves the outcome in heart failure patients in the emergency department. Two additional studies demonstrated that the BioZ's Impedance Cardiography (ICG) can be used to manage critically ill patients in place of the invasive pulmonary artery catheterization procedure. Michael Perry, CardioDynamics CEO, said, "These critical outcome studies further demonstrate the accuracy and importance of our noninvasive ICG technology ... These studies fortify our direct sales force efforts for outpatient heart failure treatment, as well our strategic alliance with GE Marquette's sales force for the hospitals' critical care and emergency departments."
CardioTech International (Woburn, Massachusetts) reported ethical committee approval to begin clinical investigation with its MyoLink small diameter compliant vascular prosthesis from the Royal Free Hospital and University College Medical School (London). The MyoLink graft is designed "to fill the void of surgical options available to patients with reduced circulation to the lower limbs, thereby improving clinical outcome and significantly increasing quality of life," the company said in a statement. The study will recruit 20 patients who require lower limb arterial bypass, and is aimed at below knee bypass where present synthetic vascular grafts are generally regarded as unsatisfactory. Alan Edwards, managing director of CardioTech, said, "Through our formal collaboration with the department of vascular surgery at the Royal Free Hospital, we have completed the pre-clinical work needed to enter into this exciting stage of product development. The clinical studies are an integral part of the process for the European Union's CE marking."
COR Therapeutics (South San Francisco, California) and Schering-Plough (Madison, New Jersey) reported that enrollment in the ESPRIT study of Integrilin (eptifibatide) Injection in 2,400 patients undergoing coronary intervention with stenting has been halted early after an almost 50% reduction in death or heart attack at 30 days at an interim analysis. Stoppage of the trial was recommended by an independent data safety monitoring committee which determined that the study should be stopped due to the significant reduction in the combined incidence of death or myocardial infarction with Integrilin compared with placebo over 30 days following a stenting procedure. The reduction was seen as early as 48 hours in the interim analysis of 1,758 patients. The committee concluded that there was no difference in the incidence of severe bleeding events between Integrilin and placebo, though there was a modest increase in the incidence of moderate bleeding with Integrilin.
Draximage, the radiopharmaceutical subsidiary of Bio-Technology General (Iselin, New Jersey), has begun a Phase III clinical trial of Fibrimage, a diagnostic agent for the detection of deep vein thrombosis (DVT). Fibrimage is a lyophilized (that is, freeze-dried) kit containing FBD labeled with the active ingredient Technetium-99m, prior to use. The product is based on Fibrin Binding Domain (FBD), a recombinant polypeptide with high binding affinity for fibrin, the primary component of DVT. FBD was developed by Bio-Technology General and is licensed to Draximage on an exclusive, worldwide basis. Completion of the Phase III trial, involving 130 patients at various centers across Canada, is expected this year.
EndoTex Interventional Systems (Cupertino, California), a developer of medical applications for thin nitinol, reported FDA approval of its NexStent carotid stent Phase I investigational device exemption, allowing the company to proceed with Phase I clinical trials of the product. Approximately 45 patients will be enrolled at six U.S. sites. The first eight NexStent carotid stents were implanted recently in patients in Argentina and Chile under investigational use. The NexStent is a 30 mm long, conformable, continuous mesh stent for use in vessel diameters of 4 mm to 9 mm.
First Medical (Mountain View, California) said it received a U.S. patent covering fluid transport and sample separation technologies. Titled "Peristaltic System and Method for Plasma Separation," it is the first of several patents expected by the company covering the methods used to move fluid from a closed sampling tube and perform separation steps without biohazard exposure. The technology is deployed in the Alpha Dx system, a rapid immunoassay platform for testing whole blood. The company's first product quantitates up to four cardiac markers for diagnosing and monitoring of acute myocardial infarction. First Medical develops decision support systems combining rapid whole blood immunoassay panels with proprietary software.
Irvine Biomedical (Irvine, California) reported successful completion of Phase I clinical trials with the Super-4 catheter ablation system, indicated for use in the treatment of Type I atrial flutter. The study involved treating 10 patients at three sites. The Super-4 system consists of the IBI-150OT4 radiofrequency (RF) ablation generator and the Super-4 steerable, multi-electrode ablation catheter. The IBI-150OT4 RF ablation generator delivers 150 watts, while the Super-4 catheters are equipped with temperature sensors at each of four ablation electrodes. Programmable software allows delivery of RF energy in either sequential or simultaneous modes to create linear lesions in the endocardium.
Medtronic (Minneapolis, Minnesota) has received FDA clearance for its Reveal Plus Insertable Loop Recorder (ILR), which it calls the "first implantable heart monitor with new auto-activation capabilities." The monitor is designed to give physicians more precision in diagnosing the cause of suspected heart-related symptoms such as dizziness, palpitations, seizures, or syncope. Smaller than a pack of gum, the Reveal Plus recorder is placed under the skin of the upper chest using local anesthesia and continuously monitors the heart's electrical activity and records ECG information in a 42-minute loop, replacing old ECG data with new data which is stored and can be non-invasively retrieved by the physician. The Medtronic Reveal Plus ILR is the second-generation successor to the Medtronic Reveal recorder, introduced in 1998 and thus far implanted in nearly 5,000 patients worldwide.
NMT Medical (Boston, Massachusetts) has FDA approval for another indication for its CardioSEAL Septal Occluder under the agency's Humanitarian Use Designation regulations, the third such approval received for the device since September 1999. The new approval is for closing patent foramen ovale (PFO) in patients with recurrent cryptogenic stroke, due to presumed paradoxical embolism through a PFO, and who have failed conventional drug therapy. PFO is a transient hole in the heart that may open under straining efforts (such as coughing or defecating) and has been implicated as a possible cause of embolic strokes.
North American Scientific (Chatsworth, California) reported that Theseus Imaging subsidiary has achieved a significant technical milestone in clinical studies of its Apomate kit for use in imaging apoptosis associated with organ transplant rejection. Using the Apomate kit for the preparation of Technetium Tc-99m recombinant human Annexin V, Theseus successfully correlated noninvasive imaging of apoptosis with biopsy-proven cardiac transplant rejection. Nuclear medicine images obtained using routine instrumentation demonstrated localization of the imaging agent in patients with transplant rejection, compared to the current protocol of repeated cardiac catheterization and endomyocardial biopsy. Apomate uses a non-invasive imaging procedure featuring a new technique involving molecular imaging of the biochemical changes associated with rejection.
Nortran Pharmaceuticals (Vancouver, British Columbia, Canada) reported the presentation of studies showing the ability of Nortran's compounds to block cardiac potassium channels. This feature of the company's anti-arrhythmic drug candidates helps ensure that Nortran's drugs not only are effective, but also are safe. The data confirms primate tests showing that Nortran's drug candidates are strongly atria-selective. The data showed that all four drugs tested demonstrated significant blocking of the potassium channels that are most important in the atria of the heart. This specific ion channel blockade contributes significantly to the ability of the drug candidates to safely prevent or treat atrial arrhythmia. The data were presented at the annual meeting of the Western Pharmacology Society.
PharmaSonics (Sunnyvale, California) has introduced its URx intravascular sonotherapy (IST) technology at the EURO-CVS Cardiovascular Summit, which showcased new international developments in interventional cardiology and cardiovascular surgery. In live telecasts of two patient cases, the URx IST system was demonstrated to more than 1,300 physicians and other health care professionals attending the conference in The Hague, the Netherlands. IST is designed to preventing in-stent restenosis caused by intimal hyperplasia. PharmaSonics says it is the first company to use sonotherapy, which is therapeutic ultrasound energy delivered via catheter, for this therapeutic application.
Radiance Medical Systems (Irvine, California) has received an FDA investigational device exemption (IDE) to begin human clinical trials of its RDX Catheter Radiation Delivery System. The trial will assess the value of the RDX system in reducing the recurrence of restenosis following the interventional treatment for atherosclerotic disease. Titled BRITE (Beta Radiation to Reduce In-Stent Restenosis), the study will evaluate the device's use in patients who have previously had a coronary stent implanted and have returned with restenosis at the implant site. Approval of this IDE is conditional upon the company's providing additional technical information. The initial phase of this multi-center study will begin immediately and is expected to be completed prior to the end of 2000. Dr. Ron Waxman, director of vascular brachytherapy at Washington Hospital Center (Washington), will be the principal investigator for the initial phase of the study.
Somanetics (Troy, Michigan) said that clinical study results demonstrate that the INVOS Cerebral Oximeter is effective in identifying vasospasm during long-term monitoring of sub-arachnoid hemorrhage (SAH) patients. The INVOS Cerebral Oximeter is the only patient monitoring system commercially available in the U.S. that non-invasively and continuously monitors changes in the regional oxygen saturation of the blood in the adult brain. The study evaluated 55 aneurysmal SAH patients monitored continuously with the INVOS and twice daily with transcranial Doppler exams and concluded that the cerebral oximeter was effective as a non-invasive, non-operator-dependent tool for identifying vasospasm and guiding medical and neuro-interventional therapies. Rocco Armonda, MD, director of cerebrovascular surgery and interventional neuroradiology at Walter Reed Army Medical Center (Bethesda, Maryland), said that traditional evaluation of cerebral ischemia in post-aneurysmal subarachnoid hemorrhage patients "is expensive, invasive and technically demanding. The cerebral oximeter is a very effective device for identifying early signs of potential ischemia."
Spectranetics (Colorado Springs, Colorado) has received FDA 510(k) clearance to market its Spectranetics Support Catheter for accessing and/or crossing lesions, primarily to provide support to an angioplasty guidewire. The catheter complements Spectranetics' other one-time-use products for interventional cardiovascular therapy. The company plans to begin marketing the Support Catheter during the current quarter and believes it is a high-margin product in a market estimated at 30,000 procedures annually. Spectranetics specializes in technology for interventional cardiovascular therapy and also excimer laser technology for peripheral vascular applications.
SpectRx (Norcross, Georgia) has demonstrated a working palm-sized laser prototype device for creating microscopic holes in skin as part of its bloodless continuous glucose monitoring system under development. The prototype creates a pattern of micropores in the dead outer layer of skin through which interstitial fluid is collected in a three-day patch. A study conducted by SpectRx, and presented at the 1999 American Diabetes Association meeting, with 20 diabetics wearing the continuous monitoring system, showed a correlation coefficient of 0.90, when compared to a finger stick method, over a glucose range of 60 mg/dl. to 400 mg/dl.
St. Jude Medical (St. Paul, Minnesota) reported the first implants of its Genesis system, a new device-based ventricular resynchronization system for the treatment of congestive heart failure (CHF) and suppression of atrial fibrillation (AFib). Genesis is comprised of the Frontier 3x2 electrical stimulation device, the Aescula LV Left-Heart Lead and the Alliance Left-Heart Delivery System (LHDS). The Frontier 3x2 device and Aescula LV lead were implanted using the Alliance LHDS in a Class 4 heart failure patient and a Class 3 heart failure patient. Daniel Starks, president and CEO of St. Jude's Cardiac Rhythm Management Division, said the system helps to manage "several complex cardiac conditions that can be significantly worse when they occur together." The Frontier device and Aescula lead provide ventricular resynchronization therapy for the treatment of CHF, and the Frontier also incorporates St. Jude's Dynamic Atrial Overdrive algorithm for the suppression of AFib.
Sulzer Carbomedics (Angleton, Texas), the critical care company of Sulzer Medica (Winterthur, Switzerland), has received FDA clearance to market the AnnuloFlex flexible annuloplasty ring for mitral valve repair. The AnnuloFlex ring is implanted in the heart's mitral valve in order to recreate and maintain the normal shape and function of the mitral valve. If the natural valve's annulus, or opening, is expanded or distorted, the heart valve will allow the blood to leak back through the valve after it has closed. This can weaken the patient's heart and physical condition. The AnnuloFlex ring also enables customizing of the implant according to the patient's valve disease or surgeon preference. First implantations of the AnnuloFlex ring occurred on Jan. 18 at the Mayo Clinic (Rochester, Minnesota) and the Downstate Medical Center (Brooklyn, New York). Additionally, the company recently introduced the CardioFix Pericardium for intra-cardiac repair and pericardial closure. CardioFix is a patch, prepared from bovine pericardium, used to repair both congenital and acquired defects within the heart. The CardioFix patch has both CE and FDA authorization.