FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams

/PRNewswire/ -- The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.

About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI's magnetic and radiofrequency fields can disrupt the pacemaker's setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.

The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker's use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.

"FDA's approval of the Revo pacemaker represents an important step forward toward greater device innovation," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI."

The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.

Revo is manufactured by Medtronic Inc. of Mounds View, Minn.

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Detecting Esophageal Cancer with Light

A tiny light source and sensors at the end of an endoscope may provide a more accurate way to identify pre-cancerous cells in the lining of the esophagus.

Developed by biomedical engineers at Duke University and successfully tested on patients during a clinical trial at the University of North Carolina at Chapel Hill, the device holds the promise of being a less invasive method for testing patients suspected of having Barrett’s esophagus, a change in the lining of the esophagus due to acid reflux. Acid reflux occurs when stomach acid splashes, or refluxes, up into the esophagus.

Long periods of acid reflux can change the cells that line the esophagus, making them appear more like intestinal cells than esophageal cells. These cellular changes can also be a precursor to cancer. As in most cancers, early identification of these pre-cancerous cells often leads to better outcomes for patients. Barrett’s esophagus afflicts more than one percent of the U.S. population, with most patients above the age of 50.

Using an endoscope to reach the esophagus via the nose, physicians shine short bursts of this light at locations of suspected disease and sensors capture and analyze the light as it is reflected back. In particular, they are trying to spot characteristic changes within the layer of cells known as the epithelium, which line cavities and surfaces throughout the body.

“By interpreting the way the light scatters after we shine it at a location on the tissue surface, we can the spot the tell-tales signs of cells that are changing from their healthy, normal state to those that may become cancerous,” said Neil Terry, a Ph.D. student working in the laboratory of Adam Wax, associate professor of biomedical engineering at Duke’s Pratt School of Engineering, who developed the device.

The team published their findings online in the January issue of the journal Gastroenterology.

“Specifically, the nuclei of pre-cancerous cells are larger than typical cell nuclei, and the light scatters back from them in a characteristic manner,” Terry continued. “When we compared the findings from our system with an actual review by pathologists, we found they correlated in 86 percent of the samples.”

UNC gastroenterologist Nicholas Shaheen, M.D., conducted the preliminary clinical trial of the device on 46 patients with Barrett’s esophagus.

“Currently, we take many random tissue samples from areas we where we think abnormal cells may be located,” Shaheen said. “This new system may make our biopsies smarter and more targeted. Early detection is crucial, because the cure rate for esophageal cancer that is caught early is quite high, while the cure rate for advanced disease is dismal, with a 15 percent survival rate after five years.”

The technology that Wax and his team developed for cancer detection is known as angle-resolved low coherence interferometry (a/LCI). The technique is able to separate the unique patterns of the nucleus from the other parts of the cell and provide representations of its changes in shape in real time.

“This optical approach of sampling allows us to cover more tissue sites in less time and has the potential to significantly improve our ability to spot and monitor these pre-cancerous cells,” Wax said. “This type of approach could be used to improve and perhaps one day supplant the physical biopsies currently being used.”

Wax pointed out that since approximately 85 percent of all cancers begin within the layers of the epithelium in various parts of the body, he believes that the new system could also work in such cancers as those of the colon, trachea, cervix or bladder.

The research was supported by the National Institutes of Health, the National Science Foundation and Oncoscope, Inc., a company Wax founded in 2006, based on the Duke technology. Wax has a financial interest in the company, and Terry is a consultant.

Oncoscope plans a clinical trial of the system for approval, and Wax said there could be a commercially available device as early as 2012.

By Richard Merritt

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FDA approves devices for heart failure patients

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients. The new use is for patients with an abnormality known as left bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. The three devices, all manufactured by Boston Scientific Corp., are intended to treat patients with left bundle branch block who have either mild heart failure or heart failure with no apparent symptoms.

The CRT-D device combines two functions. As an implantable cardioverter defibrillator (ICD) it senses dangerous abnormal heart rhythms and then attempts to shock the heart back into a normal rhythm. As cardiac resynchronization therapy, it generates small electrical impulses to coordinate the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body.

CRT-Ds are to be used as an addition to, not a replacement for, heart failure drug therapy.

“This approval allows heart failure patients with left bundle branch block to benefit from this therapy," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is pleased to safely make this new technology available for a greater number of heart failure patients."

The FDA based its approval on the results of the 1,820-patient Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) clinical study. The study which followed 1,820 patients for an average of nearly three years at 110 centers in the United States, Europe, Canada, and Israel. It compared CRT-D therapy to ICD-only therapy in specific heart failure patients to determine whether it reduced the risk of death and heart failure. In patients with left bundle branch block, who represented 70 percent of the study group, CRT-D showed a reduction in the risk of death and heart failure by 57 percent, as compared to ICD alone.

The rate of complications was considered to be acceptable by the FDA for this device, however, physicians should adequately inform patients about potential complications.

As a condition of FDA approval, Boston Scientific must conduct two post-approval studies. One study will evaluate complications and long-term mortality benefits of CRT-D in patients with left bundle branch block identified through the National Cardiovascular Data Registry. The other will follow patients from the original MADIT-CRT clinical study every six months for five years to assess long-term mortality benefits of CRT-D vs. ICD.

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FDA Approves New Device for Adults with Severe and Persistent Asthma

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

“The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system.

The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

Possible side effects during the course of treatment may include asthma attacks, wheezing, chest tightness or pain, partially collapsed lung (atelectasis), coughing up blood (hemoptysis), anxiety, headaches, and nausea. The Alair system is designed to reduce the number of severe asthma attacks on a long-term basis. However, there is a risk of immediate asthma attacks during the course of the treatment.

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, those patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device. Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.

Asthma patients considering the Alair system should not be treated while the following conditions are present: an active respiratory infection, coagulopathy (bleeding disorder), asthma exacerbations, or if they have had changes to their corticosteroid regimen 14 days before the proposed treatment.

Asthmatx Inc. is based in Sunnyvale, Calif.

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FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients

The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.

The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as transplants.

Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle pump blood to the rest of the body. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.

A physician designates the pump’s speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump’s operation.

“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”

In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population.

As a condition of the FDA’s approval, the company will conduct a post-approval study to further evaluate the device’s performance. The data will be recorded in the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS) and made available when the post-approval study is concluded. The INTERMACS is a clinical outcomes registry managed by the FDA, the National Heart, Lung and Blood Institute at the National Institutes of Health, the Centers for Medicare & Medicaid Services and participating hospitals and companies.

HeartMate II is manufactured by Thoratec Corp. based in Pleasanton, Calif.

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PrimaBella™ - First FDA-Cleared Prescription Device for Non-Invasive, Drug-Free Relief of Morning Sickness - Now Available

(BUSINESS WIRE)--PrimaBella™, the only non-invasive prescription therapeutic device cleared by the U.S. Food and Drug Administration (FDA) for the treatment of nausea and vomiting due to pregnancy (NVP), is now available. Providing a non-invasive, drug-free treatment for morning sickness, PrimaBella™ has been proven to be safe for both mother and developing baby and can offer quick relief -- the majority of patients report an immediate improvement in NVP symptoms.1

PrimaBella™ is a Class II neuromodulation device worn on the wrist, helping pregnant women experience relief from morning sickness without the concern of negative side effects from drugs, such as sedation.

“PrimaBella™ gives patients peace of mind while providing relief from potentially debilitating nausea and vomiting during pregnancy,” said Mike Hulse, MD, an OB/GYN and Chief of Staff at Northside Hospital Cherokee, in Atlanta, Georgia. “PrimaBella provides physicians like me with an effective treatment for managing NVP patients. PrimaBella’s adjustable features helps patients feel in control of their symptoms.”

Nausea may be a result of a dysrhythmic output of the central nervous system, resulting in an erratic stomach rhythm. When activated, PrimaBella™ emits gentle pulses through the median nerve on the underside of the wrist, which travel to the nausea center in the brain. These gentle pulses regulate the nausea signaling process between the brain and stomach (via the vagus nerve), restoring normal stomach rhythm and providing relief of nausea and vomiting.

PrimaBella™ is reimbursable by most insurance plans. For more information, visit www.PrimaBellaRx.com.

About Nausea and Vomiting Due To Pregnancy (NVP)

NVP affects approximately 70-85% of pregnant women and can range from mild symptoms, with a short duration, to severe symptoms that last throughout the pregnancy2. The most severe form of morning sickness (hyperemesis gravidarum) affects approximately 0.5–2% of pregnant women.2 The precise cause of NVP remains unknown.3 Nausea can occur at any time of the day although it is most common upon waking thus earning the common term, morning sickness4.

About PrimaBella™

PrimaBella™ neuromodulation device is intended for use in the treatment of nausea and vomiting due to pregnancy (NVP). PrimaBella™ technology is licensed by Alaven® Pharmaceutical LLC from Neurowave Medical Technologies™. The device is sold through prescription distribution channels and promoted to obstetricians and gynecologists by Alaven’s professional sales force.

IMPORTANT SAFETY INFORMATION

INDICATION: The PrimaBella™ Neuromodulation device is available by prescription only for the treatment of nausea and vomiting due to pregnancy (NVP).

WARNINGS: PrimaBella™ should only be used on the designated area. Nausea and vomiting may be signs of a serious health problem, seek medical attention if symptoms continue. PrimaBella™ is not a curative and should always be used under medical supervision. Treatment outcomes may vary depending on patient characteristics and any medications a patient may be taking. PrimaBella™ should be kept out of reach of children. Pacemaker users: Use this device only as directed on the wrist to prevent possible interference with your pacemaker. Avoid placing the electrodes of the device directly on your chest or near pacemaker. Consult with your physician if you have other implanted devices. PrimaBella™ should not be used above an IV line attached to a patient’s arm. If a patient is using an IV line, PrimaBella™ should be placed on the opposite arm.

CAUTION: PrimaBella™ contains natural rubber latex, which many cause allergic reactions, and is not recommended for use in conjunction with electrocautery or MRI equipment.

SIDE EFFECTS: Skin irritation can occur beneath or around the electrodes. If irritation occurs, move the device to the other wrist. If irritation does not disappear within 24 hours, stop using the device and consult your doctor or pharmacist. Continued use of the device on irritated skin may cause skin injury.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or other health care professional licensed in the state in which they practice.

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Emory, Georgia Tech, Children's Healthcare of Atlanta Team Up on Kidney Replacement Devices for Kids

When children need kidney dialysis because of disease or congenital defects, doctors are forced to adapt adult-size dialysis equipment. No FDA-approved kidney replacement devices exist that are specifically designed for children.

To address this problem, physicians and researchers from Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology have teamed up to develop a kidney replacement device capable of treating children.

Over the past five years, the three institutions have further solidified a cohesive relationship aimed at medical discovery, quality-care improvement and health care innovation.

The team has been awarded a Challenge grant of $1 million from the National Institutes of Health (NIH) to refine a prototype device. The grant is part of the American Recovery and Reinvestment Act (ARRA) funding. Challenge grants are part of a new NIH program to stimulate rapid advances in focused disease areas.

Matthew Paden, MD, assistant professor of pediatrics (critical care) at Emory University School of Medicine and a physician at Children’s Healthcare of Atlanta, is the grant’s principal investigator. Ajit P. Yoganathan, PhD, Regents’ Professor of biomedical engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, is the grant’s co-investigator.

“The adaptations doctors are forced to perform make adult kidney replacement devices inaccurate and potentially dangerous when used with kids,” Paden says. “We have invented a new continuous renal replacement therapy device that is designed specifically with kids in mind. It can be used accurately on a six-pound child, all the way up to a football linebacker.”

In the United States, it is estimated that at least 5,000 children per year, or 1 percent of the 500,000 children admitted to intensive care units, require some form of renal replacement therapy. Children may need kidney replacement therapy because of severe infections that lead to the kidney-damaging inflammatory condition called sepsis, or because of congenital defects, which can only be permanently remedied by a kidney transplant.

Paden says adult dialysis equipment can have a tendency to withdraw too much fluid from a pediatric patient, leading to dehydration and loss of blood pressure. Other possible problems resulting from inaccurate dialysis equipment include clotting or internal bleeding. Part of the problem is that the volume of blood required to fill up the tubes leading to and from the apparatus is too large, Paden says. As the child gets smaller, the proportion of blood outside the body gets larger.

Existing dialysis equipment for adults takes up space comparable to a refrigerator, while Paden says the team’s goal is to have a pediatric device the size of a shoebox.

The inventors:

Lakshmi Prasad Dasi, PhD, former research engineer at Georgia Tech, now assistant professor of mechanical engineering at Colorado State University.
James Fortenberry, MD, pediatrician in chief and medical director of critical care for Children’s Healthcare of Atlanta, and clinical associate professor of pediatrics (critical care) at Emory School of Medicine
Matthew Paden
Ajit Yoganathan

The team’s plan is to test their prototype in the laboratory and prepare for live experiments over the next two years, with the goal of being ready for clinical trials in five years.

“This is a project where we are taking technology from the laboratory bench to the basinet,” Yoganathan says. “First, we have to build a machine capable of reliably performing these tasks without damaging blood cells in the process.”

The team’s prototype device is also designed to work in tandem with equipment that replaces the function of the heart and lungs for severely ill patients. Extracorporeal membrane oxygenation (ECMO) equipment is commonly used in neonatal intensive care units for newborns whose lungs can’t work properly. Children requiring ECMO often have fluid overload and swelling. The demand for ECMO has been rising because of H1N1 influenza, which in severe cases leads to respiratory failure.

Emory, Georgia Tech and Children’s Healthcare of Atlanta are in the process of patenting the kidney replacement device. As the technology is developed further, it could be licensed to an existing company or a new start-up company.

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FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.

"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," said Kathleen Uhl, M.D., director of the FDA's Office of Women's Health. "Bleeding can be so heavy that women must miss work, school, or social activities."

"In the primary clinical trial, women using Mirena showed a statistically significant reduction in menstrual blood loss," said Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research.

Participants in the clinical trial had excessive menstrual blood loss prior to treatment and did not have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.

Mirena is recommended for women who have had a child. Clinical studies to support both the contraception and heavy menstrual bleeding indications have excluded women who have never been pregnant.

Since its approval in 2000, the most serious adverse reactions reported in patients using Mirena for any indication include: ectopic pregnancy (a pregnancy in which the fertilized egg grows outside the uterus); intrauterine pregnancy (a pregnancy with Mirena in place); group A streptococcal sepsis; an infection called pelvic inflammatory disease; embedment of the device in the uterine wall; and perforation of the uterine wall or cervix.

The most common adverse events reported by patients in the primary clinical trial using Mirena to treat heavy menstrual bleeding included uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness.

Mirena is made by Bayer HealthCare Pharmaceuticals, Inc., Wayne, N.J.

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American Biotech Labs(R) Obtains FDA Approval for New Wound Care Gel Product

/PRNewswire / -- American Biotech Labs, LLC (ABL), developer of a new class of products based on the company's patented nano-catalytic SilverSol Technology(R), today announced that the company has been granted formal approval by the U.S. Food and Drug Administration (FDA) to market its ASAP Wound Dressing Gel throughout the United States. Clifton Mining Company is a major shareholder in American Biotech Labs.

The FDA 510(k) medical device approval letter confirms that ABL may market ASAP Wound Dressing Gel "for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations." The product utilizes ABL's innovative SilverSol Technology, which has garnered multiple patents in the U.S. and several countries throughout the world, including a broad-use patent that provides the company with exclusive rights to use its silver-based products to combat many of the world's most destructive pathogens, including malaria, tuberculosis, MRSA and HIV.

"We are delighted with the FDA's decision to grant approval for ABL to broadly market our ASAP Wound Dressing Gel," said Dr. William Moeller, a managing director of American Biotech Labs. "We feel this is a singularly effective wound care product, and it is a tremendous validation for us that ABL products have now received approval from the FDA as well as from the EPA."

ABL has performed extensive anti-microbial studies against bacteria, yeast, fungus and other pathogens. Information about these studies is available at research section of the ABL Website, www.americanbiotechlabs.com/researchprotected/researchmenu.html.

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FDA Approves Cardiac Adhesion Barrier for Pediatric Use

The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.

Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.

Adhesions are bands of scar tissue that develop after surgery, infection, or other trauma. The bands can develop in any part of the body but are most commonly found in the abdomen, pelvis, or chest. Cardiac adhesions bind the outer membrane of the heart to surrounding tissue, which may restrict heart activity and complicate any additional surgical treatment. While scar tissue is part of the body’s natural healing response, adhesions can become densely fibrous and difficult to surgically navigate, which can pose problems for patients who require repeat surgeries.

In the United States, there are 350,000 to 400,000 children with congenital cardiac abnormalities. Many neonatal and infant patients must undergo multiple surgeries before their defect is corrected while other children require additional operations as they grow. This product gives physicians another tool to help decrease this type of complication that may occur.

Repel-CV is intended for children who are likely to require additional heart surgery. In a clinical study, patients who received Repel-CV were found to have less area of severe adhesions—21 percent of the surgical site. Patients who did not receive Repel-CV were found to have severe adhesions occupying 47 percent of the surgical site.

“Designing and testing medical devices for children is challenging because they are still growing,” said Daniel G. Schultz, director of FDA’s Center for Devices and Radiological Health. “Approval of Repel-CV is an example of FDA’s commitment to work with regulated industry to make more safe and effective pediatric medical devices available.”

Repel-CV is manufactured by SyntheMed Inc. in Iselin, N.J.

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FDA Approves Humanitarian Device Exemption for Deep Brain Stimulator for Severe Obsessive-Compulsive Disorder

The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

The Reclaim system uses a small electrical generator known as a pulse generator to create electrical stimulation that blocks abnormal nerve signals in the brain. This small battery-powered device is implanted near the abdomen or the collar bone and connected to four electrodes implanted in the brain through an insulated electric wire known as the lead. Two device systems may be implanted to stimulate both sides of the brain or one device may be implanted with two lead outputs.

Human device exemptions facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people per year in the United States. To receive approval, a company must demonstrate the safety and probable benefit of the device.

“Deep brain stimulation using the Reclaim system may provide some relief to certain patients with severe obsessive compulsive disorder who have not responded to conventional therapy,” said Daniel Schultz, M.D., director, Center for Devices and Radiological Health. “However, Reclaim is not a cure for OCD. Individual results will vary and patients implanted with the device are likely to continue to have some mild to moderate impairment in functioning and continue to require medications.”

OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as handwashing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these actions provides only temporary relief, but not performing them markedly increases anxiety.

The approval of the human device exemption was based on a review of data from 26 patients with severe treatment resistant OCD who were treated with the device at four sites. On average, patients had a 40 percent reduction in their symptoms after 12 months of therapy. While all patients reported adverse events, the majority of these events ended after an adjustment was made in the amount of electrical stimulation.

Patients who require electroconvulsive shock therapy should not be implanted with the Reclaim device. Other patients who should not use the device include persons who will undergo magnetic resonance imaging (MRI) or deep tissue heat treatment known as diathermy.

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