An aneurysm is a weak, enlarged area in an artery (blood vessel). Over time, the force of normal blood pressure can cause it to rupture, which can be life-threatening and cause significant disability in survivors. The American Association of Neurological Surgeons estimates that every year 30,000 people in the United States experience a ruptured brain aneurysm. Aneurysms are more prevalent in people ages 50 to 60 and three times more prevalent in women.

The size of an aneurysm can vary from small (less than .25 inches) to giant (larger than 1.25 inches). Its shape may also vary; for example, it may be balloon-like with a narrow neck extending from the artery or it may resemble a bulge with a wide or indistinct neck.

The Pipeline Embolization Device (PED) is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy that can be used to block off large, giant, or wide-necked aneurysms in the internal carotid artery, a major blood vessel supplying blood to the front of the brain. The device can also reduce the likelihood that an aneurysm will rupture.

To implant the device, the Pipeline is attached to the end of a catheter, which is inserted into an artery in the leg. The catheter is threaded into the carotid artery and into position at the aneurysm where the Pipeline is expanded against the walls of the artery and across the neck of the aneurysm, cutting off blood flow to the aneurysm. The blood remaining in the blocked-off aneurysm forms a clot which reduces the likelihood the aneurysm will grow bigger or rupture. Aneurysms successfully treated with the Pipeline will often shrink over time.

“The Pipeline Embolization Device offers neurointerventional surgeons an alternative to open surgery or placement of materials such as coils or a liquid embolic when treating carotid artery brain aneurysms,” said Christy Foreman, acting director, Office of Device Evaluation, Center for Devices and Radiological Health.

As part of the approval process, the FDA reviewed results from a study that followed 108 patients between ages 21 and 75 who had a large or giant aneurysm with no discernable neck in certain sections of the internal carotid artery. Results showed that one year after implantation 70 percent of aneurysms remained blocked off without significant narrowing (stenosis) of the section of the artery treated with the Pipeline device.

The same study tracked adverse events associated with the Pipeline and showed that ten strokes occurred in 9 patients in the year after treatment, significantly less than the 20 percent rate expected for this condition. Patients also experienced minor adverse events such as headache, bleeding, nausea and vision problems.

The Pipeline should not be used in patients with an active infection or patients who cannot take antiplatelet therapy (medication that interferes with blood clotting), such as aspirin. Patients should receive adequate antiplatelet therapy prior to surgery to place the Pipeline. The Pipeline device should not be used to treat an aneurysm with a stent previously placed across its neck.

The Pipeline Embolization Device is manufactured by ev3 of Menlo Park, Calif.

Source:
U.S. Food and Drug Administration

St. Jude Medical ablation catheters are used to help treat cardiac arrhythmias, which are irregular heartbeats that impair the heart’s ability to effectively pump blood throughout the body. Ablation catheters are thin flexible tubes that deliver radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions, or tiny scars, that interrupt the abnormal electrical signals that contribute to irregular heart rhythms. Because the amount of energy required to create an effective cardiac lesion must be carefully balanced against tissue temperature, the Safire BLU and Therapy Cool Path ablation catheters were designed with an irrigated catheter tip. Irrigation can help to reduce some of the risk factors associated with the heat of the RF energy.

The Safire BLU and Therapy Cool Path irrigated ablation catheters feature a bi-directional deflection capability that provides enhanced maneuverability, which allows physicians to reach challenging anatomic locations. The bi-directional steering turns up to 180 degrees in both directions to allow physicians to better position the tip of the catheter during ablation procedures. This flexibility promotes efficiency and was designed to provide electrophysiologists with increased control over their delivery of ablation therapy.

The bi-directional steering in these catheters is complemented by a shaft that is designed to more efficiently transmit torque (or turning force) from the steering handle to the catheter tip. This improved capability enables the physician to position the catheter with greater precision.

“The new bi-directional irrigated ablation catheters from St. Jude Medical offer innovative features that provide additional control when treating cardiac arrhythmias. The torque response, catheter tip stability and ability to make very fine movements result in excellent catheter performance in complex ablations,” said Dr. Larry A. Chinitz, Director of Cardiac Electrophysiology and Invasive Cardiology at New York University School of Medicine.

The handles of the Safire BLU and Cool Path catheters were designed to be ergonomically appealing and provide physician comfort for both routine and complex ablation procedures. Physicians have the flexibility to choose the handle style that they prefer – the ComfortGrip(TM) for the Safire BLU catheter or push/pull style handle for the Therapy Cool Path catheter.

“The improved handling and catheter control of our new bi-directional catheters can assist physicians in accessing difficult-to-reach anatomic locations. This will allow for more predictable, repeatable and effective lesion formation so physicians can focus their attention on the patient,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “St. Jude Medical is pleased to offer these two new catheters and provide physicians the unique benefits of bi-directional steering, along with the choice of handle that best suits their preference.”

Source:
St. Jude Medical

“The Clik Anchor is easy to use and gives me confidence that the lead is secure,” said Salim Hayek, M.D., Ph.D., of the University Hospitals Case Medical Center in Cleveland, Ohio. “This new product will benefit my patients and my practice with simpler, more consistent lead anchoring.”

According to the National Center for Health Statistics, pain is the most common reason Americans seek medical treatment, and an estimated 26 million Americans experience frequent back pain. Tens of thousands of patients with chronic pain have found that SCS systems help them manage their pain. Spinal Cord Stimulation is a reversible therapy that manages pain through an implantable pulse generator and external devices that control therapy and charge an implant.

Boston Scientific’s Precision Plus SCS System, powered by SmoothWave™ Technology, masks pain signals by delivering independently controlled pulses of electricity through SCS leads. Anchors are designed to secure leads and minimize unwanted migration.

“With approval and launch of the Clik Anchor, we have added six new products to our Neuromodulation portfolio in the past year,” said Michael Onuscheck, Senior Vice President and President of Boston Scientific’s Neuromodulation Division, a leader in microelectronic implantable technologies used to treat chronic neuropathic pain. “The Clik Anchor complements our SCS percutaneous leads portfolio, and gives physicians the most comprehensive array of lead options in the market.”

The Precision Plus SCS System is indicated as an aid in managing chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

Source:
Boston Scientific

The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit allows neurosurgeons to create a bypass without shutting off the blood flow. It consists of a small platinum ring and a hand piece connected to a surgical laser and suction tubing.

Standard bypass surgery in the brain requires clipping the artery to halt blood flow during the procedure. The surgery is not considered safe for about 1,000 patients annually in the United States because temporarily shutting off their blood flow would put them at high risk of stroke. The group includes patients ages 13 and older who have an enlarged, weak area in a brain artery (cerebral aneurysm), tumors at the base of the skull that could impact blood flow in brain arteries, or other issues that could complicate conventional surgery.

“The ELANA Surgical Kit may help those with a rare condition for whom there previously was no treatment option,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

To create the bypass, a surgeon sutures the ring and a section of replacement blood vessel onto the surface of the affected artery. Once attached, the surgeon tunnels the tip of the laser handpiece down the open end of the replacement blood vessel until the tip of the laser touches the ring.

The laser then cuts a circular hole in the affected artery, and suction removes the cut tissue. The process is repeated with a second replacement blood vessel. Once both replacement blood vessels are in place, the open ends of the two replacement blood vessels are sutured together to complete the path around the aneurysm or tumor.

The FDA approved the ELANA Surgical Kit as a Humanitarian Use Device, which is a device that is designed to treat or diagnose a disease or condition in fewer than 4,000 people in the United States each year. To obtain approval for humanitarian use, a company must demonstrate the safety of the device and that the probable benefit outweighs the risk of illness or injury. The company must also show that no comparable devices are available to treat or diagnose the disease or condition.

The clinical data in support of approval demonstrated that a bypass created using the ELANA kit had the same types and similar incidences of adverse events reported in the medical literature as conventional bypass procedures.

A patient should not undergo laser bypass surgery using the Elana kit if the arteries show signs of arteriosclerosis or calcification at the surgery site, the walls of the affected artery are thicker than a carotid artery, or have an abnormality. Bypass surgery with the Elana should not be done on an aneurysm or on vessels other than large (> 2.5 mm), intracranial arteries.

In some cases, the laser does not completely cut through an artery wall leaving a tissue flap that potentially could block blood flow and result in an embolism. As part of the approval, the FDA required a post approval registry study to collect performance information about the kit, including flap retention rate, mortality, and stroke.

Source: U.S. Food and Drug Administration

The LigaSure Curved, Small Jaw, Open Sealer/Divider, the newest addition to the LigaSure family of advanced surgical cutting/sealing devices, provides an integrated cutting mechanism independent of sealing, leaving the critical cutting decisions in the hands of the surgeon. Its multi-functional design also provides for blunt dissection and an enhanced, more efficient experience for the surgeon, especially in confined surgical spaces. A primary feature of this new LigaSure device is a low-temperature profile and minimal thermal spread to surrounding tissues.

The proven LigaSure technology, powered by the ForceTriadTM energy platform, provides surgeons with a continuous output of energy, monitoring the tissue and making real-time adjustments 3,333 times/second to seal vessel walls. LigaSure technology has been in use for 12 years, and is utilized in more than one million procedures around the world each year.

Source:
Covidien

“This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems,” said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health. “This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers but continue to assure that data stored, transferred or displayed on these systems remain reliable.”

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification.

Examples of MDDS products include: devices that collect and store data from a glucose meter for future use or that transfer lab results to be displayed at a nursing station for future use.

Prior to this rule, first proposed in 2008, FDA considered these devices to be either Class III (or high-risk) devices requiring premarket approval or accessories to an existing medical device.

By down-classifying these devices into Class I, the FDA is exempting all manufacturers of MDDS from premarket notification and applying the level of regulation reserved for low risk devices. Moreover, these manufacturers must comply with all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events and complying with FDA’s Quality Systems regulation, a basic system of manufacturing and design controls that, among other things, will ensure manufacturers test their products before marketing them.

The rule also levels the playing field for medical device manufacturers. Information technology companies that design, install or market these systems, and hospitals that develop them in their facilities, must follow Class I requirements as well.

The Medical Device Data Systems rule will be published in the Federal Register tomorrow and is available for advanced viewing today.

Source: U.S. Food and Drug Administration

The new proposed Innovation Pathway program for pioneering medical devices, highlighted in a report published on the FDA’s website today, is part of a broader effort underway in the FDA’s Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers.

The initiative will also seek to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science. Proposed actions include:

- establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product’s development and clinical testing stages;

- creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and

- using more device experience and data collected outside the United States.

In addition, CDRH intends to engage in formal horizon scanning – monitoring medical literature and scientific funding in a systematic way to predict where technology is heading. CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs.

“Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions,” said CDRH Director Jeffrey Shuren, M.D., J.D. “CDRH’s Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs.”

The FDA has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) to review a brain-controlled, upper-extremity prosthetic designed to restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation. The arm system uses a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis. DARPA and the FDA have signed a Memorandum of Understanding addressing both the development and review of this project.

The proposed Innovation Pathway program includes the following features:

- products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;

- selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and

- products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.

Because of the transformative nature of the devices that would be eligible for this pathway, CDRH expects them to generally be approval pathways intended for either high risk or novel products.

The FDA could conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.

CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center’s White Oak campus.

Source:
U.S. Food and Drug Administration

As Congressional Republicans ready their assault on President Barack Obama’s health care reform law, Bay State Sen. Scott Brown said Monday that he would file legislation to chip away at the bill by repealing the medical device tax that he said will stymie job growth in Massachusetts.

The 2.3 percent excise tax on medical device manufacturers is scheduled to go into effect after Dec. 31, 2012. While Brown has previously called for the tax’s repeal, his pitch Monday as part of a broader legislative agenda to grow jobs in Massachusetts refocused attention on a potential point on common ground between the Republican and would-be challengers in 2012.

Brown, delivering a speech to the North Suburban Chamber of Commerce in Woburn, named the medical device tax one of two provisions in the law – along with the expanded 1099 tax expenditure reporting requirement on businesses – that he will file legislation to repeal in the new session.

“The medical device tax is another provision in Obama’s healthcare bill that is particularly bad for Massachusetts, and I am introducing a bill to repeal the medical device tax without increasing the deficit. The medical device industry in Massachusetts is critical to our economy, and our state cannot afford this tax,” said Brown, who has also supported efforts by House and Senate Republicans to repeal the entire bill.

U.S. Rep. Michael Capuano, a potential Brown challenger who ran unsuccessfully in the Democratic primary after the death of former Sen. Edward Kennedy, said Monday he was supportive of both changes, though he disagreed with Brown on overall repeal.

“Those are two things I agree with him on,” Capuano said. “There’s lots of places we can find agreement, but at the same time, the Senator and others tried to repeal the entire bill. If they want to talk about details, I’m happy to talk. If they want to repeal the bill, I will not vote for the repeal of the bill. I will not cost the government that much money. I will not deny health care to any single American.”

Obama and some Congressional Democrats have indicated a willingness to make changes to the health care law, including alterations of an expanded tax reporting requirement that will flood businesses with new paperwork. The health care bill includes a requirement that all companies issue 1099 tax forms to any individual or corporation from which they buy more than $600 in goods or services in a tax year, apart from the typical contract workers who must receive and fill out those forms.

Following the signing of the federal Patient Protection and Affordable Care Act in March 2010, Dr. Thomas Sommer, president of the Massachusetts Medical Device Industry Council, warned that the tax could lead to layoffs or a reduction in spending dedicated to research and development of new products.

Sommer said device manufacturing is a $7.5 billion-a-year industry in Massachusetts, employing 21,000 people and contributing 10 percent of the state’s exports. The 225 device manufacturing companies in Massachusetts produce $6 billion in annual sales, he said at the time.

“It means that companies will need to make a choice whether to pass that price increase along to consumers or to absorb it themselves,” he said. “If we pass it along to customers, then we’re not doing anything about containing health care costs.”

Gov. Deval Patrick on Monday resisted being drawn into the long and ongoing debate on the medical device tax.

“That’s something I’m very sensitive to because we have a strong medical device industry here. My understanding is they were at the table working with Sen. Kerry in the development of the original bill,” Patrick said. “I don’t think I want to give or ought give a seat-of-pants reaction. I’m all about trying to strengthen our industry here.”

Sen. John Kerry’s office could not immediately be reached for comment, but Senate President Therese Murray said he hoped the Massachusetts delegation would take a look at revising the tax.

“I would love to see some kind of change on the medical device portion of the health care bill because it’s a big portion of the companies we have here,” Murray told the News Service. “I just met with a new start-up company that’s going to be manufacturing here. That would be a good thing for us. I don’t know what the financial impact would be on the overall bill, but hopefully it’s something they’re looking at.”

The debate over tweaking aspects of the federal health care overhaul came on a day when a federal court in Florida struck down Obama’s health care law as unconstitutional, joining a Virginia judge who previously said the federal government lacks the Constitutional authority to mandate that citizens to purchase health care.

The requirement that citizens purchase health insurance or face tax penalties was modeled off of the Massachusetts health care reform law passed by the Legislature in 2006 and signed by Gov. Mitt Romney. Despite being credited with helping to insuring over 98 percent of the state’s populations, critics of the federal law such as Romney have argued that the decision to mandate health coverage is one best left to the states.

“I don’t even want to get into that,” House Speaker Robert DeLeo said when asked whether he would urge the state’s delegation to Washington to consider repealing the tax in light of its potential impact on jobs. “I think that’s a federal issue and I’ll leave that up to them. I think we’ve got our issues with what we can do right here in Massachusetts.”

Atrial flutter is an arrhythmia associated with the right atrium of the heart that affects nearly 1 million people in the U.S. Patients with Type 1 atrial flutter may exhibit symptoms including palpitations, shortness of breath, fatigue, lightheadedness and fainting. Catheter ablation has become a first-line treatment approach for patients with recurrent Type 1 atrial flutter, demonstrating more successful short- and long-term outcomes compared to anti-arrhythmic drugs.

“The Blazer Open-Irrigated Catheter combines a new technique for irrigated ablation with the reliability of the proven Blazer platform,” said Emile Daoud, M.D., Section Chief, Cardiac Electrophysiology, Ross Heart Hospital at the Ohio State University Medical Center in Columbus, who performed the first U.S. procedure. “The open-irrigated catheter performed well with excellent maneuverability, torque and catheter stability.”

The Blazer Open-Irrigated Catheter integrates Total Tip Cooling Technology with the high-performance Blazer® Catheter Platform. Total Tip Cooling Technology is intended to offer consistent cooling of the entire ablation tip electrode throughout radiofrequency energy delivery.

“The first U.S. use of the Blazer Open-Irrigated Catheter highlights our continued focus on providing the most advanced ablation technologies to electrophysiologists,” said Hank Kucheman, Executive Vice President and President of Boston Scientific’s Cardiology, Rhythm, and Vascular Group.

In the U.S., the Blazer Open-Irrigated Catheter is an investigational device and is limited by applicable law to investigational use only and is not available for sale.

Source:
Boston Scientific

TPE (also referred to as plasmapheresis) is an extracorporeal blood purification technique to remove part of a patient’s blood called plasma, while replacing it with another substance such as fresh frozen plasma or a solution containing albumin. TPE may be performed to treat immunological, hematological, and neurological disorders.

“We are delighted to introduce this exciting new product to our customers, as therapeutic plasma exchange capability adds to the advantages that the NxStage System One offers,” stated Joseph E. Turk, Jr., President of NxStage’s North American operations. “By leveraging the simplicity, ease of use and flexibility of the NxStage System One we are further enabling staff to customize therapy in order to better meet the clinical needs of their patients.”

Source: NxStage Medical, Inc