CryoCath Technologies (Kirkland, Quebec), a developer of cryotherapy products to treat cardiovascular disease, said it has received the CE mark for CryoVasc, a catheter for the treatment of chronic cardiac ischemia. Cardiac ischemia is the inadequate flow of blood to a region of the heart, often resulting in severe angina. The company noted that CryoVasc is the sixth cardiac product it has commercialized in Europe. This European approval follows a key U.S. method and device patent issued in June, providing the company with broad coverage for its cardiac ischemia program. "A major commercial opportunity exists for a safe and effective therapy for chronic ischemia. Today's announcement allows us to efficiently move forward with international thought leaders to ultimately position CryoVasc as a best-in-class solution," said Steve Arless, president and CEO of CryoCath. "This approval also highlights our longer-term corporate strategy of augmenting our growing franchise in the field of cardiac ablation with other high-growth opportunities in interventional cardiology," he told BBI.
CryoVasc is a steerable 7 Fr catheter used to deliver cryotherapy in the range of -20 degrees C to -80 degrees C to trigger the formation of new arteries (arteriogenesis), the type of blood vessel that carries oxygenated blood to the cardiac tissue. The CryoVasc, "like the laser catheters goes into the left ventricle and can stimulate, through these controlled freezes, the release of growth factors that causes the growth of new blood vessels," Arless said, calling the technique a form of mechanical angiogenesis. "We've been able to show, scientifically, that when you injure by freezing smooth muscle cells . . . there is an elevated level of vascular endothelial growth factors [VEGF]. We think that this heightened level of VEGF contributes to new muscular artery growth that we see in the animal model when we injure them with cryo. It's not for the purpose of ultimately killing tissue; its for stimulating cardiac tissue to release growth factors that results in the growth of new blood vessels."
The company was inspired to use cryo in the treatment of ischemia by observing its application by such companies as CardioGenesis (Foothill Ranch, California) and PLC Systems (Franklin, Massachusetts) that use lasers to create tiny channels in the heart muscle to trigger the mechanisms of angiogenesis. Ultimately, the company will have to show that its device is superior to these lasers, some of which already have U.S. approval. "We've been able to show in the animal model that we can produce much larger blood vessels [than lasers]," Arless said. "Whether that translates to better clinical outcomes remains to be seen."
Each year there are approximately 260,000 chronic cardiac ischemia patients worldwide who have no surgical or interventional option. In addition to these "no option" patients, another conservatively estimated 300,000 patients undergoing bypass surgery or angioplasty cannot be fully revascularized, making the total available market for cryo-induced arteriogenesis therapy in excess of $500 million worldwide, the company estimated. Europe accounts for approximately a third of this global market.
Elsewhere in the product pipeline:
Anamed (Lake Forest, California) said the FDA has allowed the Phase II expansion of a clinical trial with its PermaVision intracorneal lens for the correction of hyperopia (farsightedness) up to +6 diopters. The agency agreed to allow the firm to immediately enroll an additional 100 eyes in up to five different sites. The PermaVision intracorneal lens is implanted in a sutureless surgical procedure. A flap is created in the cornea, the micron-precisioned lens is placed under the flap and centered over the pupil. The flap is then folded back over the lens and the eye. Fluid dynamics keeps the lens and the flap in place, with no stitches necessary. Unlike LASIK, which removes tissue, this procedure is additive, allowing the lens to be removed or exchanged.
Baxter International (Deerfield, Illinois) and Cerus (Concord, California) subsidiaries said that the companies reached agreement with the FDA on steps for regulatory approval for their pathogen inactivation system for platelets. Baxter and Cerus have been in ongoing discussions with the FDA throughout the submission of their modular application for their pathogen inactivation system for platelets. The steps that have been agreed upon include conducting a supplemental platelet transfusion study and performing additional analysis of the U.S. Phase III clinical trial data. The clinical trial will be carried out using the commercial set and will provide additional data to address FDA questions related to platelet performance in the U.S. Phase III clinical trial. This commercial set has previously undergone successful European clinical testing and is now commercially available in Europe. The two companies expect to complete the additional steps in the next 15 to 18 months with regulatory submission to follow shortly thereafter. Baxter and Cerus' pathogen inactivation system is being developed to potentially protect patients by reducing the risk of transfusion-transmitted diseases.
BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) introduced its BD Vacutainer Push Button Blood Collection Set, a new technology designed to improve the safety of blood collection. BD said the Push Button Blood Collection Set helps improve safety through its design: the needle automatically retracts into the device when the healthcare worker pushes the activation button with his or her index finger. Activation of the safety mechanism while the needle is in-vein reduces the risk of needlesticks. BD said it was encouraged by positive feedback from the 86 healthcare workers at four hospitals in three states, and 13 additional phlebotomists, who participated in pre-launch clinical trials of the device. Based on its design, as well as feedback from healthcare workers, BD said it anticipates that training requirements will be minimal.
Biopure (Cambridge, Massachusetts) said the FDA has told the company it will complete its review and act on its biologic license application (BLA) for Hemopure (hemoglobin glutamer-250 bovine) by Aug. 29. Biopure has applied to market Hemopure in the U.S. for the treatment of acutely anemic patients undergoing orthopedic surgery and for the elimination or reduction of red blood cell (RBC) transfusions. The BLA includes clinical data from a multinational Phase III orthopedic surgery trial and from a similar non-U.S. Phase III general non-cardiac surgery trial. It also contains an integrated database of all 22 Hemopure clinical trials, encompassing more than 1,400 total subjects, of which more than 800 received Hemopure. Hemopure is an oxygen therapeutic consisting of chemically stabilized bovine hemoglobin formulated in a balanced salt solution. This stabilized hemoglobin circulates directly in plasma when infused, increasing oxygen diffusion to the body's tissues.
Biotronik (Portland, Oregon) reported FDA approval of the Tachos ATx implantable cardioverter defibrillator (ICD). The Tachos ATx helps physicians completely manage both atrial and ventricular arrhythmias in their ICD patients. New treatment options available in the Tachos ATx device offer the physician the flexibility to monitor, discriminate and treat the progression of recurring atrial tachyarrhythmias. The device provides multiple options for terminating atrial arrhythmias, including ATP, HF burst, and cardioversion therapy. As demonstrated in the TACT (Tachos Atrial Conversion Therapy) clinical study, HF burst therapy proved to be the industry's most effective painless therapy for the treatment of AF-detected episodes. Patients' quality-of-life indicators also showed significant improvement with the frequency and severity of patients' symptoms being reduced by nearly 40%. The Tachos ATx ICD also includes Biotronik's SMART Detection dual-chamber discrimination algorithm, which the company said is the industry's most effective arrhythmia discriminator with a clinically proven sensitivity/specificity of 100% and 94%, respectively. Other competitive features include 32 minutes of stored, dual-channel electrograms, accelerometer-based, rate-adaptive pacing, backup pacing for all atrial therapies, mode switching and an extensive diagnostic package.
Boston Scientific (Natick, Massachusetts) reported the launch of the Blazer RPM advanced navigation and ablation catheter the first bi-directional navigation catheter available in the U.S. The Blazer RPM catheter features the Blazer catheter platform coupled with the advanced mapping and recording functions available through the RPM (Realtime Position Management) system. Advanced mapping and navigation is a recent advancement that provides guidance of the ablation catheter while creating three-dimensional representations of the heart chambers. By creating visual maps of the heart's conduction system, it can assist in the identification of complex tachycardias. The RPM system integrates advanced mapping, navigation and electrophysiology recording into one unit, allowing a single operator to perform all of the functions. The company said the introduction of the Blazer RPM navigation and ablation catheter means RPM system users now have a choice of ablation technologies: temperature controlled ablation with the Blazer RPM catheter or fluid-cooled ablation with the Chilli RPM closed-loop cooled ablation catheter. Boston Scientific also reported receiving FDA approval and the CE mark for the Cutting Balloon Ultra2 microsurgical dilation device. The company immediately launched monorail and over-the-wire versions of the device in both markets. The device features tiny, longitudinally mounted atherotomes (microsurgical blades) that help reduce resistance of a lesion to expansion. The atherotomes create incisions that relieve stress in the artery as the balloon inflates, reducing the force necessary to expand the vessel. The device's fold mechanism shields the atherotomes and protects the vessel wall as the catheter is passed to and from the treatment site. The Cutting Balloon Ultra2 device combines the company's Maverick2 balloon catheter technology with Bioslide coating and enhancements to the balloon and microsurgical blades. As a result, the Cutting Balloon Ultra2 device's blades are 25% more flexible, the enhanced tip provides for easier guidewire insertion while a newly applied laser bonding technique provides additional flexibility and crossability. The Cutting Balloon Ultra2 is designed to be used as a stand-alone treatment for complex lesions or as a pre-dilatation device for the pre-treatment of lesions where stents will be placed.
Canon USA's (Irvine, California) Medical Systems Division said it showed several new digital radiography (DR) products at the Symposium for Computer Applications in Radiology (SCAR) in Boston, Massachusetts, that feature a variety of medical technology advances and increased versatility to help medical professionals provide improved patient care. One new system, the Canon CXDI-50G, is a large-area portable DR system that can be used at a patient's bedside. The CXDI-50G combines a large imaging area (14" by 17") with a lightweight design (10.6 pounds and less than an inch thick) that extends the range of radiographic exams that can be completed with DR. The product has received FDA 510(k) premarket clearance.
CardiacAssist (Pittsburgh, Pennsylvania) received 510(k) clearance from the FDA for its Transseptal Cannula, a part of the company's TandemHeart Percutaneous Transseptal Ventricular Assist (PTVA) System. Cardiologists and cardiac surgeons typically prescribe the TandemHeart System in critically ill heart failure and cardiogenic shock patients for short-term circulatory support. The FDA 501(k) clearance now allows the company to market the complete minimally invasive TandemHeart PTVA System to physicians across the U.S. as a short-term circulatory support system. The Transseptal Cannula is the final component of the TandemHeart PTVA System to be cleared by the FDA. The TandemHeart PTVA System was previously awarded the CE mark for commercial sale in Europe in 2000. CardiacAssist said it continues to evaluate the TandemHeart PTVA System in the U.S. at various centers through a pivotal FDA clinical trial. This cardiogenic shock trial is now over 30% complete, and is investigating the hemodynamic support of the TandemHeart PTVA System compared to conventional intra-aortic balloon pump therapy.
Cardiac Science (Irvine, California) said that the June 1 edition of the American Journal of Cardiology includes a clinical study that demonstrates the high level of sensitivity and specificity of the company's Powerheart CRM fully-automatic bedside monitor defibrillator in detecting and providing therapy for life-threatening supraventricular tachycardia (SVT) arrhythmias, which often result in sudden cardiac arrest. The 98-patient study was performed at the Arizona Heart Institute's (Phoenix, Arizona) electrophysiology laboratory and was designed to determine how well the Powerheart device and its embedded proprietary Rhythmx software technology could discriminate between SVT and ventricular tachycardia and determine if life-saving defibrillation therapy was appropriate.
CardioTech International (Woburn, Massachusetts) reported the conclusion of an in vivo study using a microporous polyurethane-encapsulated coronary artery stent. This opens a potential market of $3 billion annually in the drug-eluting stent field, the company said. Eleven Yorkshire pigs were implanted for 30 days with a microporous stent using CardioTech's proprietary ChronoFlex polyurethane. The microporous encapsulation was achieved by using a proprietary electrostatic technique. At the conclusion of the experiment, the implant sites were evaluated for neointimal area, medial area and percent stenosis at the proximal, middle and distal edge locations. The ChronoFlex polymer showed no signs of causing inflammation, or intimal hyperplasia in the arterial walls.
Encore Medical (Austin, Texas) said that its Surgical Division has introduced the Foundation Shoulder offset head system. The new system, for use in shoulder implants, offers orthopedic surgeons numerous sizes of replacement glenoid and humeral products, and allows for a vast variety of options in head alignment. Using a Foundation stem and an offset head, the Foundation Shoulder System is designed to address the specific needs of each individual. The addition of offset heads to the Foundation Shoulder System has increased surgical options and intra-operative flexibility, while maintaining ease of use. The Foundation Shoulder System offers multiple head options, two styles of glenoid components, as well as long-stem options for revision applications. The system also consists of a fracture trial system that allows surgeons to easily position the implant.
Gynecare (Somerville, New Jersey), the women's health division of Ethicon, a Johnson & Johnson (New Brunswick, New Jersey) company, said a new study shows that nearly nine out of 10 women who underwent treatment for menorrhagia (heavy menstrual periods) with the Gynecare Thermachoice Uterine Balloon Therapy System five years ago have avoided hysterectomy. The study, published in the Journal of Human Reproduction, proves that endometrial ablation performed with uterine balloon therapy offers a viable alternative for a woman seeking to avoid major surgery and preserve her uterus. The study followed up with 260 women from 10 participating centers in Europe and Canada who underwent treatment with uterine balloon therapy between 1994 and 1996. Of the 188 (72%) women that responded to the questionnaire, 25 had undergone hysterectomy and 21 had a repeat endometrial ablation procedure. Among the respondents, hysterectomy was avoided in 86%, and, among those women, 88% did not undergo a second ablation procedure.
LuMend (Redwood City, California) said the FDA has cleared an expanded indication of the Frontrunner CTO Catheter for crossing chronic total occlusions (CTOs) in the peripheral vasculature. This includes the superficial femoral artery, subclavian and iliac arteries. The Frontrunner Catheter is the only FDA-cleared device with a specific indication for crossing chronic total occlusions in both the coronary and peripheral vasculature. The Frontrunner CTO Catheter is designed to address clinical challenges by facilitating rapid and reliable placement of conventional guide wires across CTOs. The Frontrunner technology features controlled, blunt micro-dissection that gently separates atherosclerotic plaque, creating a passage through the CTO. This enables guide wire access and provides physicians with the opportunity to treat patients using less-invasive coronary procedures, the company said.
MIV Therapeutics (MIVT; Vancouver, British Columbia) said it has achieved a significant milestone by successfully passing an independent thrombogenicity animal trial of its proprietary hydroxyapatite (HAp) coating. The trial, conducted to evaluate any evidence of clotting in the bloodstream, was performed by Toxikon (Bedford, Massachusetts) under the direction of Dr. Chin Tay, PhD. Stainless steel and cobalt-chromium stents coated with MIVT's biocompatible HAp coating were implanted in the arteries of dogs. MIVT has developed two formulations of a HAp stent coating and protected these collaborative technologies with three patents. Hydroxyapatite is a biocompatible porous material that makes up bone mineral and the matrix of teeth. MIVT's thin film, nano-coated formulation is designed to protect surrounding tissue from the chemical interaction of metal stents without drugs. The multi-layer formulation is designed to provide a porous coating for drug-elution purposes and recently received a Natural Sciences and Engineering Research Council of Canada research grant.
Ortho-Clinical Diagnostics (Raritan, New Jersey), a Johnson & Johnson company, said that its Micro Typing Systems subsidiary received 510(k) clearance from the FDA to begin marketing the Ortho ProVue, the first fully automated blood banking system that will further safeguard blood collected and screened for use in transfusion medicine. The company said that when integrated with the ID-Micro Typing System Gel Test, Ortho ProVue will improve the blood bank's accuracy and productivity, and provide process control, increasing blood safety.
Proxima Therapeutics (Alpharetta, Georgia) reported the initiation of a new post-market study to evaluate the GliaSite Radiation Therapy System (RTS) as the primary method of radiation treatment in patients with newly diagnosed brain tumors. The study, conducted at the Semmes-Murphey Clinic at Methodist Healthcare (Memphis, Tennessee) and the University of North Carolina Hospital (Chapel Hill, North Carolina), aims to determine whether internally administering concentrated doses of radiation and chemotherapy directly to the tumor site could become a standard first-line approach to treating newly diagnosed brain cancer. Cleared by the FDA for the treatment of resected malignant brain tumor, GliaSite RTS is comprised of a balloon catheter that is inserted into the cavity created by the surgical removal of the malignant brain tumor, then filled with Iotrex, a proprietary liquid radiation source. Over three to seven days, GliaSite delivers radiation directly to the tissue surrounding the cavity, where tumors are most likely to recur, while reducing radiation exposure to healthy brain tissue.
St. Jude Medical (St. Paul, Minnesota) reported the enrollment of the first patients in its RHYTHM ICD V-V (left ventricle, right ventricle) optimization phase of the RHYTHM (Resynchronization Hemodynamic Treatment for Heart Failure Management) ICD study. Enrollment in this phase of the study will be completed using both control patients from the original study phase, as well as patients newly enrolled in the V-V phase of the RHYTHM ICD study. The study is evaluating the efficacy of the Epic HF implantable cardioverter defibrillator (ICD). The V-V optimization phase extends the study's protocol to include cardiac resynchronization therapy (biventricular pacing) with programmable V-V timing (programmable interventricular pacing delay). This option is only available in the V-V optimization phase. The device also can be programmed to pace either the left or right ventricle first. The initial phase of the RHYTHM ICD study protocol evaluates simultaneous biventricular pacing only. This is a double-blinded study, with both the patient and heart failure physician unaware of which patients are receiving optimization therapy.
Varian Medical Systems (Palo Alto, California) has received 510(k) clearance from the FDA to market a new version of its VariSeed treatment planning software for permanent seed implant brachytherapy, used in treating prostate cancer. VariSeed facilitates dynamic dosimetry and real-time treatment planning. The program enables clinicians to use anatomical images to create an interactive and personalized treatment plan in the operating room during an implant procedure. A new, optional Twister longitudinal volume acquisition module enables doctors to use ultrasound images of the prostate that have been taken without repositioning the probe. VariSeed 7.1 also features a new Needle Editor that permits a doctor to visualize planned seed placements within the prostate volume, and then to interactively move, add or delete seed placements and observe how the dose distribution will be affected, before using needles to place the seeds within the patient's prostate.
Venetec International (San Diego, California) reported the launch of two new StatLock catheter securement devices, StatLock IV Plus and StatLock IV Ultra. StatLock IV Plus and StatLock IV Ultra upgrade patient and healthcare worker safety, while delivering cost savings for healthcare facilities. StatLock IV Plus features the StatLock IV extension set plus a new retainer design that is easier to operate than all previous StatLock tube-set retainers. The device is universally compatible with all peripheral IV catheters. StatLock IV Ultra uses a precision-molded, over-the-hub retainer that locks it into place with one simple motion. It allows end-users to continue using any catheter extension set they choose.