“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.”

Almost all infants will suffer from an RSV infection before the age of two. According to the United States Centers for Disease Control and Prevention, RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States resulting in between 75,000 and 125,000 children hospitalized annually because of an RSV infection.1, 2

QuickVue RSV 10 detects RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients under the age of six.

“The signs of an RSV infection are often similar to other respiratory infections, and diagnosis by symptoms alone can be difficult. Our new QuickVue RSV 10 product is a reliable, easy-to-use aid in detecting RSV in children. This new product will be available for the upcoming RSV season, which normally begins in November,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “QuickVue RSV 10 offers results in 10 minutes, which can provide a significant time savings to healthcare professionals.”

QuickVue RSV 10 employs the identical test method and sample preparation of the QuickVue® Influenza A+B test, allowing for the use of the same nasopharyngeal patient specimen when testing for influenza or an RSV infection.

Source:
Quidel Corporation

The Propaq M is a new ultra-lightweight, compact device that combines highly sophisticated, advanced capabilities with the well-accepted and proven features of the Propaq monitors. New features of the Propaq M include 12-lead monitoring, a third invasive pressure channel, extensive trending and data collection, a large high-contrast color display with 4-waveform capability, a night vision goggle (NVG) mode for military and air medical night operations, and a user-removeable battery that will operate all the physiological parameters for over 7.5 hours. These new capabilities were designed into a new small, lightweight, rugged package nearly 5 lbs. lighter than currently deployed technology.

The Propaq M is a companion monitor version of the recently FDA-cleared Propaq MD transport monitor/defibrillator and has been developed to have a completely identical and common interface for operation, batteries, power supplies, blood pressure cuffs, cables, accessories, and data. This common interface between the Propaq M and Propaq MD facilitates a seamless transition and operator readiness. The Propaq M is the first transport monitor to utilize the same user interface and components as the Propaq MD, thus allowing military and air medical services to save significant expenses in training and logistics. These new products comprise the first system designed with a combination of interchangeability, flexibility, and portability to meet the special needs of critical care monitoring and therapy for the military.

“These two products, when combined, will meet the most expansive needs of the military for patient care in difficult environments,” said Jonathan A. Rennert, President of ZOLL. “The FDA clearance of both devices is a significant milestone for ZOLL. Given the success of earlier Welch Allyn Propaq monitors and ZOLL M Series® CCT (Critical Care Transport) monitor/defibrillators, we are well-positioned to capture a significant share of the military market as the need to replace and upgrade devices creates substantial business opportunities.”

In addition to the common interfaces between the Propaq M and Propaq MD, virtually all existing Propaq 206 monitor accessories, cables connectors, and ZOLL M Series CCT defibrillation accessories currently used in military applications will be compatible with the new products.

Designed specifically for the tough demands of battlefield medicine, encompassing air transport and evacuation, and highly mobile ground, sea and air deployments of medical assets, the Propaq M meets an unprecedented number of military and international standards related to durability, environmental operation and storage extremes, radio frequency emissions, and susceptibility to spurious electrical and radio frequency noise. The Propaq M, like Propaq MD, is rated to the most stringent water and sand/dust protection, achieving a rating of IP55, allowing protection from extremely fine sand and jets of water.

Source:
ZOLL Medical Corporation

The Fridley, Minn.-based medical device giant based the bare-metal stent on its so-called “continuous sinusoid technology,” which uses fewer welds than earlier stent models, such as the Driver, and a single wire of cobalt alloy.

The company designed the device to be more deliverable, or easier to insert. The stent’s first implantation, however, allowed it to exhibit its properties of comformability, according to Washington Adventist Hospital director of cardiac and vascular research Dr. Mark Turco, a Medtronic consultant, who performed the stent’s first implantation today.

Turco told MassDevice that the procedure involved a “bifurcation in the distal right corner artery” and while it didn’t significantly demonstrate the device’s deliverability, the operation “tested comformability in that it was an angulated right corner artery and that [the device] also allowed for good access into the side branch that was involved.”

Conformability is a measure of the stent’s ability to conform to the natural shape of the vessel, according to Medtronic.

The Integrity stent is “going to hopefully allow Medtronic to have another drug-elution vehicle for their drug-eluting stent program,” Turco said.

“It will be interesting to see whether this particular design helps with things like side-branch access and in treating bifurcation lesions,” he added.

Medtronic won CE mark approval for the Integrity stent system in February and the device is available in approximately 100 countries outside the U.S. The company said the stent enabled the it to lead the bare-metal stent market in Western Europe and Central Asia.

A company spokeswoman said continuous sinusoid technology will serve as the foundation for Medtronic’s pipeline going forward. Medtronic announced the FDA approval and implantation today ahead of the 2010 Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.

“This impressive record of continuing full compliance with the federal Quality Systems Regulation demonstrates the commitment this company has to providing its customers with safe, effective reprocessed medical devices,” said Don Selvey, international-recognized expert in medical device reprocessing and ReNu Medical Board Director. “ReNu Medical continues to work diligently to reprocess non-sterile medical devices according to best practices, and to exceed customer expectations for quality medical devices.”

Since the inception of the company in 2000, ReNu Medical has been inspected by the FDA on a regular basis, in accordance with the federal laws for medical device manufacturers. Consistently, the FDA inspectors find the company to be in full compliance with all requirements.

When a deficiency is found in an inspection, FDA provides formal notice of violation and requires the company to provide a written plan to correct problems. If a company fails to correct the violation, FDA may seek sanctions against the company, up to an including civil and criminal charges. Companies with serious violations can be found through public records on the FDA website, located here.

“Consistently receiving Establishment Inspection Report’s (EIR) with zero deficiencies from the FDA, is the best assurance we can give our hospital customers and their patients, that ReNu Medical provides the safest, highest quality reprocessed products possible in the industry,” said Randy Long, ReNu Medical CEO.

ReNu recommends to hospitals that as part of any current contract review, or prior to executing a new contract with a medical device manufacturer or reprocessing company, they review the history of Warning Letters and Establishment Inspection Reports (EIR) from each company. These reports provide a clear indication to hospital purchasing agents and quality assurance authorities how that company values quality in their products.

“We follow the strictest safety protocols,” said Bruce Pierson, ReNu Medical COO. “It’s very gratifying to have the FDA recognize our proprietary methodology and protocols meet their high standards for reprocessed medical devices. Our trained professionals ensure that full regulatory compliance is employed in every step of the process delivering a 100% non-toxic, safe, quality alternative to healthcare facilities nationwide.”

ReNu continues its long standing focus on patient safety and cost savings while maintaining the highest levels of compliance with FDA guidelines and standards.

Source:
ReNu Medical

“Clearance of the AtriClip system in the United States represents a major product and clinical milestone for AtriCure,” said David J. Drachman, President and Chief Executive Officer. “We believe that the AtriClip system provides a safe and efficient method to exclude the left atrial appendage. This key innovation represents a large and exciting new growth platform and demonstrates our steadfast commitment to developing market leading technologies to meet the needs of patients and physicians.”

About the Left Atrial Appendage and the AtriClip System

The AtriClip system includes a clip device that is designed to exclude the left atrial appendage, a hollow sac-like structure attached to the heart’s left atrium. The left atrial appendage has internal peaks and valleys, or trabeculations. During AF, stagnant blood pools in the trabeculations of the left atrial appendage and is known to form clots that can migrate to other parts of the body. The AtriClip is designed to be implanted from the outside of the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria. The AtriClip system has been cleared by the FDA for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open-heart cardiac procedures.

About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue and systems for the exclusion of the left atrial appendage. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator® bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has cleared the AtriCure Isolator system and AtriCure’s multifunctional pen and CoolrailTM linear ablation device, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure’s multifunctional pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias and AtriCure’s Cryo1 system for the cryosurgical treatment of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF.

“Thanks to the hard work of thousands of talented associates, we are the largest and strongest medical device company in the world today, and poised to continue advancing patient care in the future,” said Alex Gorsky, worldwide chairman of Johnson & Johnson’s Medical Devices & Diagnostics segment.

The company’s MD&D business segment, which generated $23.6 billion in sales in 2009 and became Johnson & Johnson’s largest business segment, holds the No. 1 or 2 market positions in the majority of its markets. It includes seven global franchises:

- Cordis: a leader in the treatment of cardiovascular disease;
- DePuy: a leader in orthopaedics, spinal care, sports medicine and neurosurgical devices;
- Diabetes Care: a leader in products that allow people with diabetes to monitor and control their blood glucose levels;
- Ethicon: a leader in sutures, tissue repair and reinforcement products, women’s health, aesthetics and conditions of the ear, nose and throat;
- Ethicon Endo-Surgery: a leader in surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products, a leading developer of solutions for the reduction of healthcare-associated infections;
- Ortho Clinical Diagnostics: a leader in medical diagnostic products;
- Vision Care: a leader in the global contact lens market.

“Our MD&D businesses compete in a number of large, well-established and under-penetrated markets like joint replacement, contact lenses and sutures — markets where we can grow through the introduction of more advanced products and continued geographic expansion,” said Gorsky. “At the same time, we are expanding into other high-growth markets such as biosurgicals, energy, electrophysiology and other surgical specialties. We are using our own pipeline, as well as licensing agreements and select acquisitions, to bring us new capabilities.”

Launching New Products

Today’s presentations will highlight a number of products that have either launched this year or are continuing their global roll-outs in 2010.

Ethicon Endo-Surgery, for example, continues to introduce new energy instruments as part of its HARMONIC® family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency. Diabetes Care is rolling out a new blood glucose monitoring system, OneTouch® Verio ™ that provides the next generation of accuracy and precision, the number one need for diabetes patients. Meanwhile, Vision Care continues rolling out its 1-DAY ACUVUE® TruEye™ Brand Contact Lenses, the world’s first daily disposable silicone hydrogel lens on the market, which is currently available in Europe and Japan and is expected to launch in the U.S. later this year.

The company lobbied on parts of the health care overhaul passed into law in March that call on medical device makers to pay between $2 billion and $3 billion in fees per year to fund expanding health care coverage. While industry executives have complained about the fees, Democratic lawmakers say device companies will benefit from health care reform as more patients will become insured and therefore eligible to get their products.

The company also lobbied on efforts in Congress to make it easier for patients to sue medical device companies via personal injury lawsuits.

Medical device companies are largely shielded from patient lawsuits at the state level by a Supreme Court decision that gave federal regulators the final say in declaring a device safe or unsafe. Democrats, backed by trial lawyers and patient groups, want to overturn that decision, which they say misinterprets the law.

Medtronic lobbyists also advocated their position on a bill aimed at updating the U.S. patent system. The pharmaceutical and medical device industries have argued that reform efforts must not weaken patent protections on medical products by reducing infringement penalties. The reform effort has largely stalled in Congress.

Medtronic also lobbied on legislation that would increase the regulation of medical devices manufactured in foreign countries by charging additional user fees for FDA inspections, according to a form filed April 20 with the House clerk’s office.

Source: Business Week