Boston Scientific (Natick, Massachusetts) received its much-anticipated FDA approval in early March to market the Taxus Express2 paclitaxel-eluting coronary stent system. The clearance made the company the second to garner a U.S. approval for a drug-eluting stent (DES), behind the Cypher sirolimus-eluting stent from the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (J&J; New Brunswick, New Jersey), which earned first-to-market honors in April 2003. Boston Scientific launched the product in the U.S. immediately, and said, unlike Cordis at the time of its Cypher rollout, that it had ample inventory in all sizes. The company said it has about 225,000 units of the stent immediately available for sale.
The Taxus product, which incorporates the Express2 coronary stent on the Maverick balloon catheter as its platform, has an approved shelf-life of six months and all seven stent lengths were approved: 8 mm, 12 mm, 16 mm, 20 mm, 24 mm and 28 mm. Also, as expected, diameters between 2.5 mm and 3.5 mm were approved, and the 3.5 mm version is authorized for treatment of vessels up to 3.75 mm in diameter.
Boston Sci launched the Taxus system in Europe and other international markets in February 2003 and, in just a little over a year, has achieved commanding leadership of between 60% and 70% and beyond in many of these markets. Many analysts see the same type of market domination for the product in the U.S. as well.
RBC Capital Markets analyst Phil Nalbone wrote in a research report that he expected the Taxus to capture 15% of the U.S. DES market by the end of the first quarter, 55% by the end of 2Q04 and more than 60% of an estimated $3.8 billion market by the end of the year. "This approval is a breakthrough event for the treatment of cardiovascular disease in the U.S.," said Jim Tobin, president and chief executive officer of Boston Scientific. "Broad, consistent clinical data and extensive real-world experience have clearly demonstrated that polymer-based delivery of paclitaxel is a safe and effective therapy that dramatically reduces restenosis."
Elsewhere in the product pipeline:
Aspect Medical Systems (Newton, Massachusetts) has received 510(k) clearance from the FDA for the BISx system, a level-of-consciousness anesthesia monitoring solution that provides the processing technology required to obtain BIS (for Bispectral Index) information from a device the size of a hockey puck. Using a sensor placed on the patient's forehead, the BIS monitor is designed to translate information from an electroencephalogram (EEG) into a single number that represents each patient's level of consciousness. This number the BIS value ranges from 100 (indicating an awake patient) to zero (indicating the absence of brain activity). Using the BIS value to guide administration of anesthetic medication, clinicians are able to make informed decisions for optimal anesthesia or sedation. The BISx has been designed to integrate with a wide range of patient monitoring platforms sold by prominent monitoring manufacturers.
Bayer Biological Products (Research Triangle Park, North Carolina) reported receiving approval from the FDA for in-house nucleic acid testing (NAT) of HIV in plasma donations. Based on this approval, Bayer BP said it becomes the first plasma fractionator to perform in-house screening for HIV using a FDA-licensed test. As a result, the company said it exerts greater control in confirming the safety of its plasma donations, reinforcing the strict standards already in place for the screening and donation process. Bayer's NAT testing uses Roche Diagnostics' (Mannheim, Germany) polymerase chain reaction technology to rapidly replicate minute amounts of target DNA or RNA to detectable levels, enabling detection of disease-causing human viruses in human blood plasma earlier in the infection cycle.
Biomerica (Newport Beach, California) has introduced a new 10-minute rapid diagnostic test for detecting Helicobacter pylori, a bacterium responsible for more than 85% of ulcers. The one-step test initially will be marketed internationally to doctors and drug stores. Biomerica's rapid test, which will be marketed under the trade name EZ-H.P., uses an advanced technology that requires only a single drop of a patient's blood.
Biotronik (Lake Oswego, Oregon) reported the market release and subsequent nationwide implantations of its Lexos implantable cardiac defibrillator (ICD), the only device available in a small, physiologic shape that provides completely automated, wireless early detection of cardiac events without patient action. The company said the Lexos ICD offers four distinct advantages: a small, thin profile designed to increase patient comfort and reduce incision size; industry-proven capacitors that deliver consistent charge times throughout the life of the device; up to six years longevity that provides fewer device replacements and more cost-effective therapy; and Biotronik's Home Monitoring system. Events are automatically transmitted from the ICD to the Home Monitoring web site, which provides access to patient and device data anytime, from anywhere.
Bonutti Technologies (Effingham, Illinois) received FDA clearance to market an absorbable PLLA anchor for its TranSet Fracture Fixation System. The FDA-approved TranSet is a fracture fixation system that employs suture and anchors to set bones and tissue. The absorbable PLLA anchor slowly degrades over time, eliminating the need for surgical removal.
Cardiac Science (Irvine, California) reported the marketing launch of a new fourth-generation automated external defibrillator (AED) that targets sophisticated users of lifesaving equipment such as hospital personnel, medical professionals, paramedic firefighters and emergency medical technicians. The company said it anticipates shipments to international customers and distributors to begin in May, with sales in the U.S. pending FDA approval. The Powerheart AED G4 is specifically designed to provide healthcare professionals continuous cardiac monitoring capability and decision-making latitude during the emergency treatment of victims of sudden cardiac arrest. The G4 weighs only six pounds and includes patented features such as one-button operation, RescueReady technology which performs daily self-tests of battery, electronic systems and disposable defibrillation pads as well as configurable STAR biphasic energy protocols and RhythmX detection algorithm.
Datascope (Montvale, New Jersey) reported receiving FDA clearance to market the Trio, its new, low-acuity monitor. The portable patient monitor features full monitoring capabilities including ECG, respiration, blood pressure, oxygen saturation and temperature monitoring. The Trio also provides one of the largest and highest resolution displays in a compact, highly portable package with optional battery power for patient transport, the company said.
Doxa AB (Uppsala, Sweden) reported that the first patient has been treated using its high-strength, bioactive ceramic material, which, upon application, results in a complete chemical integration between the material and bone within a matter of moments. Surgeons at Akademiska University Hospital (also Uppsala) repaired a distal radius fracture through minimally invasive injection of the Doxa material.
EP MedSystems (West Berlin, New Jersey) reported FDA market clearance for its EP-4 Computerized Cardiac Stimulator. The product also has received regulatory approval in the European Union. The EP-4 includes several features unique in the electrophysiology (EP) industry, the company said, consisting of a touch-screen portable PC controlling a two- or four-channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings. The EP-4's four-channel constant current output provides increased versatility for site pacing and emergency backup pacing.
GP Surgical (Nashville, Tennessee), a medical products distributor,NULL, disclosed the recent FDA approval of TiMESH, a new mesh device for hernia repair. The company said TiMESH is the only composite hernia mesh made with titanium, offering surgeons and patients a new treatment option for the most common surgical procedure in America. TiMESH is specifically indicated for laparoscopic and open surgery for the repair of direct or indirect inguinal, femoral, umbilical and incisional hernias; rectal, vaginal and apical prolapses; and parietal reinforcement of tissues and abdominal wall repair. Since 2002 more than 70,000 TiMESH have been implanted inpatients in Western Europe. It is now available to the 750,000 hernia patients seeking treatment each year in the U.S. and can be used during all hernia surgical procedures.
Imaging Sciences International (Hatfield, Pennsylvania) introduced a new compact cone beam computed tomography (CBCT) system that provides what the company teremed "unprecedented" 3-D, digital imaging at half the cost of medical CT units and with less radiation to patients than traditional fan beam computed tomography systems. The i-CAT provides high-definition, in-office 3-D, digital imaging in an easy-to-use unit that requires less than 60 square feet of floor space. The i-CAT's volumetric imaging provides dentists and specialists complete views of all maxillofacial structures, allowing for more thorough diagnosis and planning, as well as more predicable treatment outcomes.
Lerner Medical Devices (Los Angeles, California) has received FDA clearance for the levia Phototherapy System, a UVB phototherapy system for the treatment of psoriasis, vitiligo, atopic dermatitis, seborrheic dermatitis and leucoderma. The levia Phototherapy System emits UVB light within the spectral band of 290 nm to 320 nm directly to the affected area. The levia Phototherapy System includes a light source, a flexible light guide, a fiber-optic brush and a spot handpiece. The desired dose is selected using controls on the Light Source console and the delivery of light to either the brush or the handpiece is controlled from the panel or with a foot switch.
Masimo (Irvine, California) has released the Masimo SET Rad-5 Handheld Signal Extraction Pulse Oximeter, or Rad-5, which it said incorporates all of the primary features of its Radical Signal Extraction Pulse Oximeter and is designed to help even the sickest patients. The Rad-5 is based on the company's main product, the Radical three-in-one pulse oximeter, but the Rad-5 was designed for its small size, long battery life of 36 hours, interface designed to be user-friendly, and multiple-day trending to enable it to be used during transport or in other situations where there is a great deal of movement, or even where power is not available. It features motion-tolerant algorithms. The Rad-5 offers a stand-alone component that can be used as a hand-held when released from the docking station.
The first implant in an expansion of Medtronic's (Minneapolis, Minnesota) ENDEAVOR II clinical trial in Europe took place last month at the Hospital of the Merciful Brother (Trier, Germany). The expanded trial arm is directed toward increasing patient exposure to the company's investigational Endeavor drug-eluting coronary stent, with a total of 300 patients to be enrolled at about 15 international sites. Data from the expanded trial will be used to support product approvals globally, Medtronic said. The Endeavor drug-eluting stent system combines the Driver coronary stent, the drug ABT-578 and a PC polymer into a system designed to reduce restenosis.The ABT-578 compound is licensed to Medtronic by Abbott Laboratories (Abbott Park, Illinois). Medtronic also licenses Abbott's proprietary phosphorylcholine coating technology, designed to serve as the delivery matrix, which controls the elution of ABT-578 directly into the arterial wall. The trial will include the standard endpoints of major adverse cardiac events (MACE) at 30 days, target lesion revascularization, target vessel revascularization and target vessel failure at nine months, with angiographic and intravascular ultrasound follow-up at eight months. The initial phase of the ENDEAVOR II trial, which included 1,200 patients, completed enrollment in January. Medtronic also reported receiving FDA approval for the first fully automated pacemaker to speed up slowly beating hearts. Enpulse is the first implantable pacemaker that does not require a doctor to regularly measure the minimum amount of energy needed to stimulate the heart to beat faster. Enpulse automatically monitors and adjusts the level of electrical impulses at regular intervals.
Medwave (Danvers, Massachusetts) said that a study titled "Near Continuous, Non-Invasive Blood Pressure Monitoring in the Out-of-Hospital Setting" was accepted for oral presentation during the Society for Academic Emergency Medicine annual meeting to be held in Orlando, Florida, in mid-May. The study tested the utility of Medwave's Vasotrac APM205A non-invasive blood pressure monitor in ground ambulances, helicopters and fixed-wing aircraft.
Nellcor (Pleasanton, California) reported the results of a study that found the Nellcor MAX-FAST Forehead Sensor provides accurate and more reliable oxygen saturation values during pulse oximetry moni- toring of patients in the pediatric intensive care unit and the operating room. The researchers also discovered the MAX-FAST sensor worked effectively on challenging patients where digit sensors failed to provide accurate readings, the company reported. The findings were presented at last month's Society of Critical Care Medicine meeting in Orlando, Florida.
Pall (East Hills, New York) said it received FDA clearance to market its new LaparoShield Conditioned Insufflation Gas (CIG) System. By conditioning the carbon dioxide (CO2) gas used in laparoscopic surgeries, it becomes more characteristic of the environment of the abdominal cavity, according to the company. Heated and humidified carbon dioxide has been shown to reduce recovery times, post-operative pain and complications. This provides a new level of safety and comfort for the rapidly growing number of patients undergoing minimally invasive abdominal surgery. The LaparoShield CIG System provides warm and humidified CO2 into a patient's abdominal cavity for insufflation during laparoscopic surgery. Insufflation is the standard medical practice where gas is blown into a body cavity in order to create space for surgical procedures. Pall is a leader in the growing fields of filtration, separations and purification.
SmartPill Diagnostics (Buffalo, New York) reported that Massachusetts General Hospital's (Boston, Massachusetts) Institutional Review Board has approved physiological trials using the SmartPill Capsule. The trials will generate data that characterizes pressure and pH in the GI tract and will involve at least eight patients. The size of a vitamin pill, the SmartPill Capsule is a capsule endoscopy device that uses patented technology to measure peristaltic pressure, pH and transit time, and determine real-time location; factors that aid in the diagnosis of gastroparesis and dyspepsia (GI motility disorders).
Sono-Tek (Milton, New York) reported the first sales of its stand-alone AccuMist stent coating system, a tool designed for use in developing processes to spray coat arterial stents with polymers containing drugs that inhibit the development of scar tissue, which can lead to the recurrence of arterial blockage. AccuMist's soft, precisely targeted spray produces uniform coatings, the company said. The stand-alone system contains facilities for programming both linear movement and rotation of the stent, and an easily accessible spray area for loading and unloading, as well as a precision liquid delivery system capable of providing a wide range of flow rates.
SpectRx (Norcross, Georgia) reported last month that it is initiating FDA pivotal clinical trials of its non-invasive cervical test by submitting final protocols to hospitals participating in the study. It also reported that any device ultimately commercialized as a result of the studies would be accomplished by its subsidiary, Guided Therapeutics, which is focused on commercializing non-invasive cancer detection technology. The formation of that subsidiary is the result of an effort to separate its diabetes and cancer opportunities. For the pivotal trials, each site's Institutional Review Board is reviewing the protocols, which were developed with input from the FDA as well as physicians from throughout the U.S. Formal testing of patients will get under way after the review process is completed, the company said. More than 1,000 women have been tested with prototypes of the cervical cancer detection devices. The device works by using the company's technology that analyzes light reflected from the cervix to identify cancers and pre-cancers painlessly and non-invasively. SpectRx said the device creates an image of the cervix designed to highlight the location and severity of disease. By detecting biochemical and morphological changes at the cellular level, the technology is able to distinguish between normal and diseased tissue. The unnamed device is different from a typical Pap or test for human papillomavirus, since it does not require a tissue sample or laboratory analysis. Also, results of the diagnostic test are available immediately.
An FDA advisory panel agreed in mid-March that an artificial heart from SynCardia Systems (Tucson, Arizona) demonstrates adequate safety and efficacy for use as a bridge to transplantation in patients with end-stage heart failure. The Circulatory System Devices Advisory Panel voted to recommend approval of the CardioWest Total Artificial Heart (TAH), provided that SynCardia agrees to several conditions. The vote was 10 in favor with one abstention. Among the lengthy list of conditions, the panel limited use of the CardioWest TAH to transplant hospitals. Another condition would require SynCardia to follow patients implanted with the CardioWest for the first year after receiving the device. The CardioWest TAH, which already is commercialized in France, Germany and Canada, keeps a patient alive until a transplant heart is available. The device completely replaces the diseased heart and immediately restores normal blood pressure and cardiac output, facilitating recovery of end-organ function, such as the kidney and liver. Marvin Slepian, company president and chief executive officer, said the device can remain inside a patient "until a new heart is available, but on average it is usually about 80 days." Developed by the University of Arizona Medical Center (Tucson, Arizona), the device consists of two ventricles connected to the respective native atria and greater vessels. An air hose or drive line covered with double velour material passes from each ventricle transcutaneously to a console that pulses pressurized air and monitors pump function.
Sysmex America (Mundelein, Illinois) reported that the Sysmex pocH-100i, a compact complete blood count and three-part differential hematology analyzer, has been cleared by the FDA. The instrument has the smallest footprint and smallest sample requirement of any hematology analyzer released by Sysmex. Sampling is done in a "closed tube" environment to assure safety for the operator, the company said.
Tecan (M nnedorf, Switzerland) reported the introduction of Freedom EVO Clinical, a series of automated liquid-handling solutions for diagnostic laboratories. The Freedom EVO Clinical provides flexible, scalable and upgradeable solutions for applications such as fully automated ELISA sample processing, blood typing and molecular diagnostic testing. The new platform offers deck sizes of 75 cm, 100 cm, 150 cm and 200 cm.
Varian Medical Systems (Palo Alto, California) reported that it has received FDA clearance of the On-Board Imager accessory for its Clinac and Trilogy medical linear accelerators. The new imaging accessory is designed to improve the precision and effectiveness of cancer treatments by giving doctors the ability to target and track tumors more accurately. The On-Board Imager is mounted on the treatment machine via robotically controlled arms that operate along three axes of motion, so that they can be positioned for the best possible view of the tumor. A 150 kV X-ray tube generates precise, high-resolution, computed tomography-quality images from a moving gantry. The On-Board Imager will be available as an option on all of Varian's newly installed high-energy Clinac linear accelerators, and as an upgrade for most digital Clinac accelerators already in place. It will be a standard feature on all Trilogy linear accelerators.
Vision-Sciences (Natick, Massachusetts) reported the introduction to the U.S. market of the ENT-1000, an EndoSheath system that includes a small (2.4 mm) diameter Ear-Nose-Throat Endoscope and a Slide-On EndoSheath. The ENT-1000 is designed to enhance the range and quality of ENT procedures. The slim insertion tube diameter is designed for ease of scope passage through small openings, while providing maximum patient comfort. At 300 mm, the overall working length enables full access to the laryngeal region, and the articulation provides maneuverability to enable ideal viewing.
VNUS Medical Technologies (San Jose, California) has introduced a new line of surgical instruments used to perform ambulatory phlebectomy, the mini-surgical removal of varicose veins. The VarEx instrument line provides a complementary solution to the Closure System, a radiofrequency device used in the treatment of saphenous vein reflux. VarEx instruments offer an octagonal handle shape, for a comfortable grip and ease of use. A broad array of tip styles, in different sizes and shapes, accommodate a variety of surgical techniques and physician preferences. All instruments are manufactured of high-quality surgical stainless steel and are reusable.