Computer Motion (Santa Barbara, California) said its Zeus Robotic Surgical System was used for the first time during a beating-heart cardiac bypass operation at the University of Pittsburgh (Pittsburgh, Pennsylvania).
A 63-year-old male patient underwent multi-vessel off-pump coronary artery bypass graft (CABG) surgery at the University of Pittsburgh Medical Center's Presbyterian Hospital in early April. Surgeons used the three-armed robot during the most important part of the operation, when the artery being used as the bypass graft is connected to the heart's main coronary artery.
The procedure marked the start of a national, multicenter trial to evaluate whether the system from Computer Motion can be helpful to surgeons and be safely used for the surgical connection of the left internal mammary artery graft to the left anterior descending artery.
Elsewhere in the product pipeline:
Advanced Catheter Engineering (ACE; Livermore, California) was granted U.S. patent No. 6,214,024, titled "Tissue Cutting Catheter and RF Cutting Method," focusing on linear radiofrequency incisions from the side of the catheter, with or without therapeutic infusion at the treatment site. The utility of the device is not limited to cardiovascular applications, according to ACE. Additional potential applications include drug delivery, percutaneous myocardial revascularization (PMR), tissue biopsy and tumor treatment devices. ACE is a privately held company specializing in surgical and catheter-based technologies.
Boston Scientific (Natick, Massachusetts) said it is launching the Quantum Monorail post-dilatation balloon catheter in the U.S. The new catheter uses the same Quantum Leap balloon material found in the Quantum Ranger catheter. The Quantum Leap balloon material features Hinge Balloon Technology, which the company said offers sizing flexibility at lower pressures and minimal growth at higher pressures. This technology combines both non-compliant balloon properties with the performance characteristics of semi-compliant balloon catheters. catheter is available in stent-matched lengths of 9 mm, 12 mm, 15 mm, 18 mm and 20 mm and in diameters from 2.5 mm to 4.0 mm.
Cares Built (Keyport, New Jersey) received 510(k) clearance for its Apollo Mobile C-Arm. The Apollo C-Arm is available in three different configurations: the Apollo Max, Apollo Plus and Apollo Mini Max. Cares Built makes retrofitable and serviceable digital x-ray systems for human diagnostic imaging.
Curon Medical (Sunnyvale, California) discussed the results of a study, published in the April 2001 edition of Gastrointestinal Endoscopy, a journal of the American Society of Gastrointestinal Endoscopy, with the study designed to evaluate the company's Stretta System for the treatment of gastroesophageal reflux disease (GERD). The multicenter study concluded that the procedure significantly improved GERD symptoms, quality of life and esophageal acid exposure while eliminating the need for acid-reducing medication in the majority of patients. The Stretta System was used to administer a dose of radio frequency energy to the junction of the esophagus and the stomach. Prior to and six months post treatment, patients' symptoms were evaluated by endoscopic examination and pH tests, with the use of GERD medications, patient satisfaction and quality of life assessed before therapy and at one, four and six months after. The survey showed that the patients, 32 men and 15 women, experienced significant improvements in all measurements of heartburn, GERD and esophageal acid exposure and physical and mental satisfaction with the treatment. Furthermore, endoscopic examination showed significant reductions in inflammation of the esophagus. Additionally, after six months, 87% of patients no longer required acid-reducing medication. No serious side effects were observed.
Imaging Diagnostic Systems (IDS; Fort Lauderdale, Florida) said that the U.S. Patent and Trademark Office awarded it a patent titled "Detector Array For Use In a Laser Imaging Apparatus," which was assigned to Imaging Diagnostic Systems as patent No. 6,211,512. The patent describes several different optics variations while scanning the breast without contact between the breast and the optical components. This feature allows the company's CTLM to scan the breast without breast compression. IDS is seeking PMA approval from the FDA for its CTLM system to be used as an adjunct to mammography to aid in the detection of breast abnormalities. Under the new modular submission approach, the company's PMA application has been divided into different modules, each of which will contain documentation required for the FDA review, and the company is completing the next set of modules to be submitted.CTLM is a laser-based breast imaging system uses laser technology and algorithms to create 3-D cross sectional images of the breast.
Invitrogen (San Diego, California) has begun selling a reagent kit to facilitate the use of Genzyme Molecular Oncology's Serial Analysis of Gene Expression (SAGE) technology, a method enabling quantitative analyses of all expressed genes in a tissue or cell line. Unlike other expression profiling technologies such as microarrays, SAGE is an open system that does not rely on a predetermined collection of genes and can be used in a variety of applications such as identifying disease-related genes, analyzing the effects of drugs on tissues and providing insight into disease pathways. Genzyme has an exclusive license for commercial applications of SAGE and offers sublicenses to commercial users of the I-SAGE kit. Invitrogen makes research tools in kit form and provides other research products and services to biotechnology and biopharmaceutical researchers.
MedAmicus (Plymouth, Minnesota) has filed a 510(k) application with the FDA for its center-line retractable Guidewire Introducer Safety Needle, a product licensed from and co-developed with Med-Design (Ventura, California). The product retracts into a protective sheath while still in the patient, eliminating the possibility of a needlestick after coming in contact with a patient's blood. MedAmicus makes products for the cardiology, gynecology and urology markets. Med-Design makes safety needle for use in the areas of blood collection, infusion therapy, insertion and injection.
Medwave (St. Paul, Minnesota) said it has submitted a 510(k) for pediatric use of its Vasotrac APM205A continual noninvasive blood pressure monitor to the FDA for review. Vasotrac is designed for measuring a patient's blood pressure on a continual basis, with updates available approximately every 15 heartbeats. The device is being used in anesthesiology, critical care, emergency rooms and cardiology departments in several countries. It has been approved for adult use in the U.S.
Medtronic (Minneapolis, Minnesota) subsidiary Medtronic AVE (Santa Rosa, California) said it has received FDA approval to commercialize its S7 with Discrete Technology coronary stent systems. The S7 coronary stent succeeds the S670 coronary stent and is intended for use in percutaneous transluminal coronary angioplasty. The device is available in both over-the-wire and rapid-exchange versions. The stent is available in diameters of 3.0 mm, 3.5 mm and 4.0 mm and in lengths of 9 mm, 12 mm, 15 mm, 18 mm, 24 mm and 30 mm. The company also said it has opened the DISTANCE trial (Direct Stenting with Angiographic and Clinical Evaluation of the S7) in markets outside of the U.S. That study is evaluating the use of the S7 in direct stenting procedures. The stent is not yet approved for direct stenting in the U.S.
Meridian Bioscience (Cincinnati, Ohio) has launched a one-step device for the simultaneous detection of two waterborne parasites, Giardia and Cryptosporidium. ImmunoCard STAT Cryptosporidium/ Giardia gives easy-to-read results in just minutes, according to the company. Giardia lamblia and Cryptosporidium are waterborne parasites causing acute diarrhea and gastrointestinal distress resulting in hospitalization in severe cases. The global market for Giardia and Cryptosporidium testing is approximately $20 million annually. Meridian makes diagnostic test kits, purified reagents and related products and offers biopharmaceutical-enabling technologies.
Misonix (Farmingdale, New York) has received 510(k) marketing clearance from the FDA for its ultrasound probe used with the SonoReal 3D imaging product. The SonoReal is an ultrasound imaging device developed by BioMediCom, an Israeli engineering company spun off from Silicon Graphics and Sonora Medical Systems. The product is an aftermarket plug-and-play device that converts diagnostic ultrasound units into 3-D imaging systems. Misonix makes medical, scientific and industrial ultrasonic and air pollution systems.
Nanogen (San Diego, California) reported receiving an additional U.S. patent relating to its electronic microarray technology, titled "Methods and Apparatus for Determination of Length Polymorphisms in DNA," the 21st issued to the company. Length polymorphisms in DNA are used in medical and forensic applications, with potential medical applications including detection of changes in the nature of these polymorphisms which may predict a change in an individual's health. The patent cover methods and devices that facilitate automation and miniaturization of repeat sequence analysis.
Nymox Pharmaceutical (Maywood, New Jersey) said that a favorable report would appear in Alzheimer's Reports, a journal published in England. The study documented the results of a large new clinical trial for its AlzheimAlert urinary test. The trial was a double-blind study involving Alzheimer's disease patients and normal controls, with overall 140 participants from five institutions. AlzheimAlert is a designed to aid in the diagnosis of Alzheimer's disease. The test detects elevated levels of a brain protein (neural thread protein or NTP) known to be elevated in the urine of patients with Alzheimer's.
Opticon Medical (Dublin, Ohio) said it will implement an engineering change to a feature of its Option-vf Urinary Catheter before proceeding with the clinical trial that it has organized. "We have an opportunity to further affect both the value and the competitive strength of our product," said Opticon President William Post. "While incorporating this change translates to delaying our patient enrollment for a relatively brief period of time, we consider it essential to have our latest technology and the most recent embodiment of our development as the centerpiece of our clinical study." The company said it does not anticipate making any change to the study protocol when it returns to its investigators to begin patient enrollment.
Organogenesis (Canton, Massachusetts) said its technology business unit submitted three 510(k) marketing applications to the FDA for its engineered collagen products. The business unit was formed in 3Q00 to commercialize Organogenesis' engineered collagen and conditioned medium technologies through partnership and distributorship arrangements. Products made from Organogenesis' Fortaflex can be designed to integrate with bordering tissue over time or remain passive in the body. Organogenesis also submitted a European marketing application for its Apligraf product for treating diabetic foot ulcers and venous leg ulcers. Novartis Pharma AG, of Basel, Switzerland, cooperated on the submission, has global marketing rights and is responsible for international regulatory filings. Apligraf is a cellular, bilayered skin substitute and would be regulated as a drug in Europe.
Ortho-Clinical Diagnostics (Raritan, New Jersey) received premarket approval from the FDA for what it said is the first diagnostic anti-hepatitis B surface antigen assay on a random access system. The company said this assay could be used as an aid in determining immunity of an individual to hepatitis B virus (HBV). The Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators is for the qualitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum using the Vitros ECi Immunodiagnostic System. The company said that the assay results may be used as an aid in the determination of susceptibility to HBV infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Ortho-Clinical Diagnostics is a Johnson & Johnson company.
Pheromone Sciences (Toronto, Ontario) reported receiving approval for the multicenter efficacy clinical trial of its PSC Fertility Monitor. The trial, to be carried out in 140 subjects, will take place at Duke University Medical Center (Durham, North Carolina) and Thomas Jefferson University Hospital (Philadelphia, Pennsylvania). The U.S. study follows on the heels of the positive clinical results reported from a pilot study conducted at Toronto General Hospital demonstrating that the monitor predicted ovulation within +/- 1.38 days of the actual date of ovulation, while also providing women with up to four days' advance notice. Pheromone is focused on commercializing technologies in the field of human reproduction and sexuality.
Purdue Research Foundation (West Lafayette, Indiana) has received U.S. patent No. 6,187,039 for a tubular medical graft made from tissue-engineered small intestine submucosa (SIS). The patent describes a tube of implantable SIS for use as a graft material for arteries, veins, ureters, urethras, shunts or any application where a compliant, biocompatible tube is needed within the body. The animal-derived SIS tissue is processed to produce a biocompatible material and the SIS material is then made into a tubular graft, the material configured into 3-D grafts of any reasonable length, wall thickness or diameter. Cook Biotech (CBI; also West Lafayette), a unit of Cook (Bloomington, Indiana), makes several medical products based on SIS. The company uses a process that it said maintains the integrity of the naturally occurring SIS acellular matrix. CBI has developed products that are surgically implanted to reinforce damaged or weakened tissues. After implantation, SIS acts as a scaffold for tissue growth and over time is replaced with the body's own tissue.
Spectranetics (Colorado Springs, Colorado) said that an article in the April 1, 2001, issue of the American Journal of Cardiology demonstrated the safety and effectiveness of excimer laser coronary angioplasty to treat a subset of patients with acute coronary syndromes. The article evaluated feasibility, safety and acute results of percutaneous excimer laser coronary angioplasty (ELCA) in acute coronary syndromes. Fifty-nine patients were treated with ELCA, including 33 patients with unstable angina pectoris (UAP) and 26 patients with acute myocardial infarction (AMI). The study showed procedural success rates of 100% and 97% for the AMI and UAP groups, respectively. Spectranetics presently contraindicates excimer laser angioplasty in AMI and acute thrombosis.
STAAR Surgical (Monrovia, California) reported receiving the CE mark for the SonicWave Phacoemulsification System used to remove a cataract lens from the eye. International shipments of the device began last month. The company's sonic technology removes cataract material by using low frequency (40 Hz to 400 Hz) sonic pulses, thus helping to avoid the generation of heat and reducing the risk of corneal burns. STAAR makes minimally invasive medical devices for use in refractive, cataract and glaucoma surgery.
Vascular Architects (San Jose, California) said it has received FDA 510(k) clearance to market its aSpire Covered Stent and Controlled Expansion Delivery System in the U.S. for treating tracheobronchial strictures. The company had recently received CE mark approval to market the device in Europe for treating peripheral vascular disease. The stent is a spiral nitinol stent completely covered by a thin layer of ePTFE, which is designed to provide greater lumen wall coverage than metallic stents. It is available in lengths of 2.5 cm, 5.0 cm and 10 cm and diameters from 6 mm to 14 mm. and is delivered using the company's Controlled Expansion delivery system. The stent and its delivery system are currently being clinically evaluated in the U.S. under two separately approved investigational device exemptions for the treatment of iliac and superficial femoral artery occlusions, and of dysfunctional arterio-venous access grafts. Vascular Architects makes devices for treating peripheral vascular disease and nonvascular obstructions.
VidaMed (Fremont, California) has launched marketing programs for its Precision Office TUNA System for the treatment of benign prostatic hyperplasia (BPH). The company received FDA marketing approval in February. VidaMed said the Precision product, designed for the physician office environment, offers a faster treatment time of 20 minutes for an average-sized prostate, compared with about 30 minutes for current therapies, including its own PROVu System. The Precision System has an intuitive user interface featuring Precise Reassurance Technology which monitors intra-prostatic temperature 50 times each second and provides real-time feedback during significantly shorter treatment cycles.
VSM MedTech (Vancouver, British Columbia) said that the launch of the BPM-100 in the U.S. was to begin May 1, through McKesson HBOC, exclusive distributor of the product. The BPM-100 automated blood pressure monitor is designed to improve the diagnosis of hypertension.