One of the most important events in the history of modern medical technology occurred last month. “Groundbreaking” is a word easily thrown about by device makers these days, but the word clearly applies to the AbioCor artificial heart – and the FDA approval that gives the go-ahead to Abiomed (Danvers, Massachusetts) for implantation of the device in up to 4,000 patients under its human exemption protocol. That approval marked the achievement of a goal that has been pursued for a half century by a variety of researchers, cardiovascular companies and surgeons, and, of course, hoped for by patients suffering very serious heart disease.
It is no small irony that announcement of the agency approval received a relatively unspectacular amount of attention. It garnered a single day’s-worth of big-story coverage from the national newspaper and TV outlets, with smaller notices by local media outlets, hardly the attention it probably deserves, and no general bannering of its real and broad importance.
The lack of bells and trumpets is perhaps, in part, the result of Abiomed’s general approach to publicity concerning the heart. In launching its 15-patient clinical trial in 2001, the company parceled out only basic information – that the implant had taken place in a particular hospital by certain surgeons, and only a few skimpy details about the patients’ status (the patients only discovered and named usually as a result of investigation by local media in their home towns). Tantalizingly few details about the procedure itself or details about patient condition were given out, with the company continually citing the need to protect the privacy of the patients and their families in order to avoid distractions that would reduce total focus on patient care.
In taking this approach, Abiomed was borrowing a useful page out of artificial heart history. It clearly was attempting to avoid the circus-like media atmosphere that had surrounded the most famous implantation of an artificial heart – the initial and truly pioneering Jarvik artificial heart implanted in the body of retired dentist Barney Clark in 1982. At the time, the use of an artificial heart appeared to be an accomplishment even more miraculous than heart transplantation, and the media were given broad access to Clark and details about his care. While that initially emphasized the pioneering quality of the Jarvik, it also then highlighted Clark’s weakening and eventual painful demise, casting a shadow over continued development of the technology and suggesting that it was just one more medical experiment gone wrong.
Despite the apparent lack of great excitement about approval of the AbioCor, the major headlines may perhaps come in the future, when the heart begins to be implanted in patients on a regular basis, and if it succeeds in providing a great many months and years of eventual life to patients.
But those headlines may be a while in coming, acknowledges Michael Minogue, president/CEO of Abiomed. While the approval marked a heady moment for the company, it will be several months before the first and follow-on implants take place on any sort of regular basis or for more than a handful of patients (the approval for implantation in 4,000 patients is perhaps several thousand-fold more than is needed). Minogue said that because the last patient (the 14th) in the company’s trial was implanted more than two years ago, a good bit of work is required to ramp up the necessary orientation and training for doing the procedure and taking it forward into regular clinical practice.
“There are a couple of phases we have to go through,” Minogue told BB&T, in describing what will be a carefully controlled roll-out to the market and patient use. Besides validating and retraining the centers that did the implantations from 2001 to 2004, Abiomed will be asking them to help train new centers. Minogue said this process would take from six to eight months, beginning with three to five centers and then expanding in phases to what he projected as 10 centers doing the procedure as “a maximum.” He declined to project the numbers of patients who might receive the AbioCor, either short-term or long-term.
That is only one aspect of a great many tasks facing the company. The FDA said it is requiring the company to provide a comprehensive patient information package to patients and families that clearly describes the risks as well as the probable benefits of the device and explains what patients should expect before, during and after surgery. And Abiomed promised the agency that it will continue to do additional laboratory studies and will also conduct a post-marketing study of 25 additional patients. The post-market study was recommended by the Circulatory Systems Devices Panel, a part of the agency’s Medical Devices Advisory Committee.
The toughest and lengthiest job of all may be in winning reimbursements from the Center for Medicare and Medicaid Services (CMS; Baltimore) and private payers. Minogue said that much of the spadework in this area has been done, but the company is likely to have a difficult time in selling its main value proposition: that although the AbioCor is essentially a life support device it may be capable of saving on healthcare costs when compared to the hundreds of thousands of dollars, or even millions, that are needed to support end-stage heart failure patients. The equation supporting reimbursement will doubtless depend largely on many dozens of uses of the heart and the actual additional amount of life that it provides to patients, in order to convince CMS of its economic and clinical benefits.
Abiomed won’t have the job of developing a large marketing campaign to find patients. Minogue said patients will be referred to the implanting hospital through physicians and the network of about 100 heart transplant centers, targeting those patients who are designated as unable to benefit from the standard heart transplant or unable to withstand the transplant procedure. Minogue acknowledged that a key to the success of the AbioCor has been – and will always be – the careful selection of patients, individuals who have very sick hearts and only a short time to live but with other organ systems working well or capable of being revived via the AbioCor. Also to be considered are the issues related to the use of anticoagulation medication.
As it prepares all the things necessary for carrying the AbioCor to actual use, the company is developing the next-generation AbioCor, the AbioCor 2, which the company hopes may be able to extend a patient’s life for up to five years, and be used in women, not just men. Minogue projected first-in-man implants for the AbioCor 2 in 2008, though it hasn’t been determined whether this will come via another humanitarian device exemption or a clinical trial in support of premarket approval. But that is just one project among the company’s growing pipeline of heart support devices. “Before we were a one-product company,” Minogue told BB&T. “Today, we’re a real company with a portfolio of products addressing the No. 1 killer, acute heart failure.”
Paralleling the gradual roll-out for the AbioCor, Minogue added: “We are conservative in our guidance. For this year, we will lose money, but we’ll grow to about $52 million in revenue.”
Elsewhere in the product pipeline:
• Abbott Laboratories (Abbott Park, Illinois) reported completion of enrollment in the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study designed to increase understanding of vulnerable plaque — a lipid-rich coronary plaque that suddenly ruptures — believed to be a key culprit in producing myocardial infarction. The vast majority of heart attacks are now believed to be triggered by the rupture of a lipid-rich vulnerable plaque hidden under a thin fibrous cap on the artery wall, causing blood to clot on the plaque and suddenly blocking the artery, according to Abbott. The PROSPECT study enrolled 700 acute coronary syndrome patients receiving stents in the U.S. and Europe. Patients will be followed for two to five years. The study will use novel intravascular imaging technology, including a virtual histology system developed by Volcano Therapeutics (Rancho Cordova, California), to correlate plaque characteristics, patient risk factors and biomarker measurements with subsequent heart attacks and other cardiac events, potentially paving the way for physicians to identify and treat at-risk patients before a heart attack occurs.
• Allergan (Sydney, Australia) reported the international launch of its LAP-BAND Advanced Platform (AP) system with Omniform Adjustable Gastric Band, its latest offering in laparoscopic adjustable gastric banding for the treatment of morbid obesity. The LAP-BAND AP system features Omniform, a 360-degree inflation area that wraps uniformly around the stomach. The device is available in two size options to accommodate varying patients and surgical techniques. Robert Grant, corporate vice president and president, Allergan, said, “The LAP-BAND AP system with Omniform Adjustable Gastric Band features design attributes of the original LAP-BAND system that minimize the potential for crease-fold failure, and also incorporates our proprietary Omniform technology that allows the LAP-BAND AP system to maintain controlled, even and round inflation throughout the adjustment range of the band.” During surgery with the LAP-BAND system, laparoscopic surgical techniques are used to implant an adjustable, reversible, inflatable band around the upper portion of the patient’s stomach, which creates a small stomach pouch that enables weight loss by creating a feeling of satiety and limiting or reducing food consumption. Allergan develops specialty device and pharma products for ophthalmology, neurosciences, medical dermatology, medical aesthetics and obesity intervention.
• American Bio Medica Corporation (Kinderhook, New York) said it has been granted a patent from the U.S. Patent Office for products in the area of saliva diagnostics. Patent No. 7,090,803 is for lateral flow immunoassay test devices that need treatment and incubation of samples such as saliva, urine, blood, plasma, serum, or cerebral spinal fluid to get a meaningful result. American Bio Medica manufactures immunoassay diagnostic test kits. Its products test for the presence or absence of drugs of abuse in urine, or for the presence or absence of drugs of abuse in oral fluids.
• Boston Scientific (Natick, Massachusetts) reported that it has enrolled more than 13,000 patients in the Taxus Olympia registry, designed to evaluate the safety and performance of the second-generation drug-eluting coronary stent (DES), Taxus Libert . Olympia is the world’s largest DES registry and plans to enroll up to 27,000 patients treated for complex coronary lesions, at more than 500 centers worldwide. The company presented six-month data from the initial phase of the Olympia registry at the European Society of Cardiology/World Congress of Cardiology 2006 in September in Barcelona, Spain. The Libert stent features the Veriflexstent design, a flexible cell geometry with thin struts and uniform cell distribution. This platform offers uniform drug delivery in challenging anatomy. Boston Scientific makes less invasive medical devices used in many interventional medical specialties.
• Bruker Daltonics (Billerica, Massachusetts) reported the availability of its ultraflex III smartbeam MALDI-TOF/TOF mass spectrometer. The new ultraflex III uses computer-controlled settings to adjust the laser focus size from 10 um to 80 um for better molecular imaging. Absorbing tissue areas can now be scanned with a very small laser focus and adjustable repetition rates from 1Hz to 200Hz. The ultraflex III boosts sensitivity and increases acquisition speed by a factor of three for LC-MALDI workflows, in comparison to the previous ultraflex II system. Bruker Daltonics develops mass spectrometry life science tools and nuclear, biological and chemical detection products for homeland security.
• CardioDynamics (San Diego) reported a draft coverage decision for hypertension from the Centers for Medicare & Medicaid Services (CMS; Baltimore), proposing to continue the current policy for coverage of impedance cardiography (ICG) for resistant hypertension, defined as patients whose blood pressure is not controlled on three or more medications. Reimbursement coverage is still provided for Medicare patients with shortness of breath and heart failure. The draft decision for hypertension coverage is subject to an immediate 30-day public comment period that was to conclude on Sept. 23. CMS anticipates a final National Coverage Determination by Nov. 21. Cardiodynamics makes noninvasive ICG products and medical device electrodes.
• Carl Zeiss Meditec (Dublin, California/Jena, Germany) has received FDA clearance for the MEL 80 Excimer Laser System for vision correction eye surgery. Results from clinical studies found that 93% of patients were corrected at three months to 20/20 or better visual acuity, and 41% were corrected to 20/12.5 or better at six months. Results also showed that 85% of patients achieved within one-half of a diopter (optical power measurement) of the intended correction at three months post-operative follow-up. The MEL 80 Laser uses a small spot size and Gaussian beam profile, creating an even corneal ablation that protects the surrounding tissue. The ablation process is very fast, so there is less dehydration of the eye. Carl Zeiss Meditec develops eye care solutions to diagnosis and treat the four main diseases of the eye: vision defects (refraction), cataracts, glaucoma and retinal disorders.
• Cepheid (Sunnyvale, California) reported its Xpert GBST test for Group B Streptococcus has been categorized by the FDA as “moderate complexity” under the Clinical Laboratory Improvement Amendments (CLIA). This allows the assay to be performed by institutions registered for CLIA moderate complexity, as well as those registered for high complexity.
• Cook (Bloomington, Indiana) reported that its Celect Vena Cava Filter was successfully implanted on a 44-year-old female patient by Murray Asch, MD, director of interventional radiology at Lakeridge Health Oshawa (Oshawa, Ontario). The product is designed to enhance the filter’s retrievability. In animal trials, the filter has been retrieved without difficulty or complication after being implanted for more than one year, which may prove beneficial to human patients whose risk of pulmonary embolism has lessened sufficiently over time to allow the filter to be withdrawn. Cook manufactures devices for radiology, cardiology, urology and women’s health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.
• Cook Urological (Spencer, Indiana) reported the availability of the Flexor DL (dual lumen) Ureteral Access Sheath and the BiWire Nitinol Core Wire Guide for the treatment of urological diseases. The Flexor DL adds a secondary, smaller lumen that provides a separate channel for additional devices such as laser fibers, stone retrieval baskets, or working wire guides. It also offers a channel for irrigation or contrast media. The BiWire incorporates two usable tips — one straight and one angled. As a result, either end of the wire can navigate through tortuous ureters. The wire guide’s bonded hydrophilic coating also provides a lubricated surface for effortless advancement. The BiWire has a nitinol core that creates a maneuverable, flexible, and kink-resistant guide for ureteral access. Cook makes products for ureteral and renal access, prostate management, ureteroscopy, and kidney stone management.
• Cordis (Miami Lakes, Florida) reported the availability of its Steer-It Deflecting Tip Guidewire for commercial use in the U.S., Canada and Europe. The Steer-It Deflecting Tip Guidewire is used in positioning catheters and other interventional devices, such as drug-eluting stents, in a patient’s coronary. It can also be used in peripheral arteries. The tip can be manipulated to bend in two directions, and is specially designed to help physicians treat hard-to-reach blockages, including those in tortuous vessels, previously deployed stents or side branches of an artery. Cordis, a Johnson & Johnson company, manufactures interventional vascular technology.
• Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) presented preliminary results from the pilot trials of the BrainGate Neural Interface System at the Neural Interfaces Workshop in Bethesda, Maryland, sponsored by the National Institute of Neurological Disorders and Stroke. The report demonstrated the ability of BrainGate to record cortical activity from a patient with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease). It also showed that a trial participant, unable to speak due to a brainstem stroke, used BrainGate to type messages using a virtual keyboard interface. Cyberkinetics makes neural stimulation, sensing, and processing technology for the neurology industry.
• Diamics (Novato, California) reported it has submitted a 510(k) premarket clearance application to the FDA for its CerCol cervical collection device. CerCol is designed to capture a mirror image sample from 360 degrees of the endocervical canal, the ectocervical area, and the transformation zone of the cervix with a single device. When the CerCol is placed in the cervix, its reusable handle allows for rotation of the disposable collector tip. Diamics manufactures molecular-based cancer screening and diagnostic systems.
• Environmental Tectonics Corporation (ETC; Southampton, Pennsylvania) reported that the Wound Healing Center at Bryn Mawr Hospital (Philadelphia) is using ETC Biomedical’s new BARA-MED XD hyperbaric chamber to support the critical healing of chronic wounds. ETC makes aircrew training systems, public entertainment systems, process simulation systems (sterilization and environmental), clinical hyperbaric systems, and environmental testing and simulation systems.
• Ethicon Products, a division of Ethicon (Somerville, New Jersey), reported launch of the Ultrapro Hernia System (UHS), utilizing the design of the Prolene polypropylene Hernia System. The UHS offers three points of protection — onlay patch, connector and underlay patch for the repair of abdominal wall defects. A reinforced underlay patch on the new UHS enables the Ultrapro Hernia System to be easily deployed by the surgeon, while the lightweight construction provides for flexibility and enhanced patient comfort, according to the company. Ultrapro features lightweight support by providing a mesh burst strength four times stronger than the maximum abdominal pressure, and tissue in-growth with a flexible scar. Indicated for open repair of abdominal wall hernia defects, the Ultrapro Hernia System is a sterile, pre-shaped, 3-D device constructed of an undyed onlay patch connected by a mesh cylinder (connector) to an underlay patch enhanced with circular dyed Prolene stitching.
• GE Healthcare (Waukesha, Wisconsin) and Volcano Therapeutics (Rancho Cordova, California) reported FDA 510(k) clearance for the integration of Volcano’s intravascular ultrasound imaging (IVUS) capabilities onto GE’s Innova all-digital X-ray cath lab imaging system – the first time such systems have been integrated. GE said that the digital cardiovascular imaging system is designed to give interventional cardiologists and interventional radiologists “a clearer view of coronary and peripheral vessel morphology in a more accessible manner than previously available.” The integrated product, which the companies will commercialize under the name “Innova IVUS,” comes as a direct result of the agreement entered into by GE Healthcare and Volcano in March. That agreement was reported at this year’s meeting of the American College of Cardiology (ACC; Bethesda, Maryland).
• Impliant (Milford, Connecticut) reported that it has received FDA approval to begin a clinical trial for its TOPS system, a total posterior arthroplasty system designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. “Our surgeon investigators view the TOPS System as a viable alternative to spine fusion to treat patients with late stage degenerative pathologies,” said Todd Potokar, president of Impliant. Impliant develops spine arthroplasty solutions for motion preservation.
• Medtronic (Minneapolis) said a study published in a recent issue of Circulation, the journal of the American Heart Association (Dallas) provided evidence of the safety and effectiveness of the Medtronic Endeavor drug-eluting coronary stent system for patients with coronary artery disease, with a clinically significant treatment effect that is being sustained over time. The trial enrolled 1,197 patients at 72 facilities in 17 countries and was the first and largest drug-eluting stent trial outside the U.S. comparing a drug-eluting stent to a bare-metal stent. “These excellent clinical outcomes have been maintained at nine months, 12 months and 24 months. Compared to bare-metal stents, Endeavor is safe and effective in reducing the rates of clinical and angiographic restenosis, and is a highly deliverable stent that has significant anti-restenosis properties and a favorable safety record with dual anti-platelet therapy,” said William Wijns, MD, the co-principal investigator of the trial.
• Nanogen (San Diego) reported that it has been issued six patents by the U.S. Patent Office for inventions related to diabetes and Alzheimer’s disease (AD) and biomarkers. Patent No. 7,052, 849,“Protein biopolymer markers predictive of insulin resistance”; patent No. 7, 049,397, “Biopolymer marker indicative of disease state having a molecular weight of 1211 daltons”; and patent No. 7,087,435, “Biopolymer marker indicative of disease state having a molecular weight of 2735 daltons,” relate to the use of mass spectrometry and time-of-flight detection to identify various biomarkers such as those associated with metabolic Syndrome X and conditions linked to Syndrome X. Early stages of Syndrome X are characterized by insulin resistance, abnormal blood lipids and high blood pressure; later stages lead to overt diabetes, kidney failure and heart failure. Patent No. 7,026,129, “IG lambda biopolymer markers predictive of Alzheimer’s disease,” and patent No. 7,074,576, “Protein biopolymer markers indicative of Alzheimer’s disease,” relate to the utilization of mass spectrometry and time-of-flight detection measures to elucidate biopolymer markers associated with Alzheimer’s disease and Syndrome X. Patent No. 7,070,945, “Process for determining the presence of monomeric brain associated human glutamine synthetase in patients exhibiting mild cognitive impairment,” claims a method for determining those patients suffering from mild cognitive impairment who have a likelihood of progressing to Alzheimer’s disease. The method involves directly detecting the presence of a biochemical marker, specifically human glutamine synthetase, by immunoassay of bodily fluids. In addition, a method for distinguishing between AD and non-AD dementia is disclosed.
• NMT Medical (Boston) reported receiving conditional approval from the FDA for modifications the company requested to its current investigational device exemption (IDE) for its pivotal patent foramen ovale (PFO) migraine clinical study, MIST II (Migraine Intervention with StarFlex Technology). The company said the changes are supported by its previous trials — MIST and BEST (BioStar Evaluation STudy). The FDA granted approval to adjust the primary endpoint for the study from resolution to reduction of migraine headaches and to upgrade the implant used in the study from the Starflex to NMT’s new bioabsorbable implant, BioStar. MIST II’s modified design will evaluate the safety and effectiveness of NMT’s catheter-based implant technology for the treatment of migraine headaches in patients with a PFO. The clinical study seeks to enroll about 600 migraine patients, who will either receive an implanted device or a fake procedure to test for the placebo effect. It appears that the company decided to alter the trial based on its experience with the first MIST trial with the StarFlex. In March results reported at the American College of Cardiology (ACC; Bethesda, Maryland) showed that the MIST trial failed to meet its goal of eliminating at least 40% of migraine headaches after six months. Also, the company apparently made good on a promise to retool the MIST II trial after the endpoint miss with its predecessor.
• OmniGuide (Cambridge, Massachusetts) reported the availability of the OmniGuide fiber, a hollow-core photonic bandgap fiber that provides a flexible delivery system for CO2 laser surgery. Omniguide works with the Massachusetts Institute of Technology (MIT; Cambridge, Massachusetts) to commercialize patented research conducted at MIT on omnidirectional reflectors and fibers.
• Perceptronix Medical (Vancouver, British Columbia) reported that Health Canada has issued a Class III in vitro Diagnostic Device License for the company’s ClearSign Sputum Test for the detection of early lung cancer. The ClearSign Sputum Test measures DNA in thousands of lung cells collected from induced sputum (the fluid from a deep cough). The test is indicated for people who are suspected of having lung cancer due to high-risk smoking or industrial carcinogen exposure, and the presence of symptoms or other indications such as suspicious radiography. Like other cancer detection tests such as the Pap or PSA test, the ClearSign Sputum Test provides a likelihood assessment for cancer to help identify people who require follow-on tests such as bronchoscopy, radiography, etc. Perceptronix makes early cancer detection technologies.
• Quest International (Irvine, California) reported that the Totoku ME551i2, 5 megapixel display has been granted FDA 510(k) clearance for use in all digital mammography applications. The ME551i2 is a 21.3 inch, 5 megapixel, DICOM-compliant diagnostic display with an 11.9-bit grayscale palette and 750 cd/m2 brightness. In addition, the (L)-Uniformity Matrix luminance equalization feature achieves highly accurate luminance uniformity across the screen. The (L)-Sentinel II photometer is mounted in front of the screen and monitors the backlight constantly to accurately stabilize luminance.
• Royal Philips Electronics (Andover, Massachusetts) reported that its line of HeartStart Defibrillators is compliant with American Heart Association (AHA), European Resuscitation Council (ERC), and International Liaison Committee on Resuscitation (ILCOR) 2005 Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC). All HeartStart Defibrillators now shipping, including the Home, OnSite (HS1), FRx, FR2+, XL and MRx, support the new protocol of single-shock defibrillation, followed by immediate CPR, which is recommended in the updated guidelines. Royal Philips is a worldwide leader in defibrillation technology and electronics.
• Siemens Medical Solutions (Malvern, Pennsylvania) introduced the Modularis VarioStar, a lithotripsy system for urological procedures. The VarioStar can be moved into under-table and over-table positions for conventional and case-specific stone treatment. Alignment control was integrated into the therapy head to monitor the relative position of the lithotripsy module to the C-arm. In case of misalignment, a signal warns the operator to interrupt treatment. Modularis VarioStar requires 510(k) review, and is not yet commercially available in the U.S.
• SpectRx (Norcross, Georgia) reported the availability of the new SimpleChoice twist and twist Pro insulin pump infusion sets with 5 mm catheters, introduced at the recent American Association of Diabetes Educators 2006 meeting in Los Angeles. The company said the less-invasive catheters are the shortest on the market and designed for ease of insertion and more comfortable wearing experience for those who use insulin pumps. The twist product line also features the only 360-degree rotating design on the market. Bill Arthur, SpectRx president/COO, said, “The freedom of movement provided by the 360-degree rotating design, combined with the shortest catheter on the market, makes the twist the infusion set product for pump wearers seeking comfort and mobility.” The SimpleChoice twist Pro is for use with Medtronic Paradigm-brand insulin pumps; the SimpleChoice twist is for use with all other Medtronic pumps as well as all makes of Deltec, Animas and Disetronic insulin pumps.
• Stryker (Kalamazoo, Michigan) reported that it has received FDA 510(k) clearance for its hip bearing system, LFIT Anatomic Femoral Heads with X3 Polyethylene liners. The new implant system combines Stryker’s Low Friction Ion Treatment (LFIT) technology with X3 advanced bearing technology and is anatomically sized for more natural hip performance. The result is total hip replacement designed to help minimize dislocation and its associated healthcare costs, while providing an alternative to metal on metal bearings. Stryker makes products and services for orthopedics including implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries.
• Synthetic Blood International (SBI; Costa Mesa, California) reported treatment of the seventh and eighth patients in a Phase IIa proof-of-concept Oxycyte study in traumatic brain injury. Consistent with the results in previous patients treated in this trial, Oxycyte administration in the two patients “significantly increased” brain oxygen tension over baseline, SBI said. Due to a data monitoring malfunction in a previously treated patient, a ninth patient will be enrolled and treated in the Phase IIa study to provide the required eight-patient trial data. Synthetic Blood said it expects to complete and report data! from this trial before the end of the year. SBI’s open-label, Phase II pilot study is being conducted at Virginia Commonwealth University.
• Uroplasty (Minnetonka, Minnesota) reported that it has received an approvable letter for its pre-market application (PMA) from the FDA for what would be the company’s third product on the market in the U.S., Macroplastique Implants, or what are known as “bulking agents” for stress urinary incontinence (SUI) in females. It would add to its I-STOP Mid-Urethral Sling, also for SUI, it said. To carry out the procedure — which can be done in a physician’s office — the physician injects through a needle Macroplastique into the muscle surrounding the urethra that has “weakened over time” in a procedure that takes 15-20 minutes. The increased bulk from the agent is designed to allow the urethra to close more effectively, preventing urine from leaking during so-called “stress” activities. Uroplasty said the approvable letter follows FDA’s completion of the scientific review of the safety and efficacy of Macroplastique. The FDA determined that the PMA is approvable, subject to the FDA’s satisfactory audit of Uroplasty’s manufacturing facilities, methods and controls and being in compliance with applicable Quality System Requirements.
• Varian (Tokyo) has introduced its 400-MR magnetic resonance spectrometer. This NMR system gives non-specialists access to state-of-the-art methods for molecular characterization and quantitation. The compact footprint of the 400-MR makes it easier to accommodate in small analytical laboratories in pharmaceutical, biotech, chemical and academic environments. Varian supplies scientific instruments and vacuum technologies for life science and industrial applications.
• WaveLight (Sterling, Virginia) reported that the FDA has approved its wavefront-guided procedure, a LASIK treatment approach that combines the Allegro Analyzer with the 200-hertz Allegretto Wave excimer laser. WaveLight said it now offers U.S. physicians the choice of Wavefront Optimized and wavefront-guided LASIK treatment options, both of which demonstrate similar outcomes in clinical studies, according to the company. The company said that the primary difference between WaveLight’s standard WaveFront Optimized systems and its Wavefront-guided LASIK system is that Wavefront-guided technology can help those patients that have spherical aberrations, which are associated with glare and halo effects and nighttime driving problems, a side effect of LASIK procedure ranging from occasional to frequent. The Allegretto Wave wavefront-guided LASIK procedure was approved by the agency for the reduction or elimination of up to -7.00 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane.