FDA Checks Off Action Item With Training Program Launches

FDA Checks Off Action Item With Training Program Launches

The U.S. Food and Drug Administration has announced two new training programs designed to improve the skills of premarket application reviewers at the Center for Devices and Radiological Health (CDRH). Officials believe that better review skills will lead to improved consistency and efficiency.

“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during premarket device reviews,” said Jeffrey Shuren, M.D., CDRH director. “This investment will improve the quality of submission review and make the process more consistent and predictable.”

The Reviewer Certification Program that officially launches this month is designed for new device reviewers. The 18-month program began as a pilot in April 2010 with participants from CDRH’s Division of Anesthesia, General Hospital, Infection Control and Dental Devices. Reviewers can take online or live courses in medical devices, food and drug law, regulatory mandates, the CDRH review process, device design and the impact of human factors.

CDRH also is developing the Experiential Learning Program for premarket reviewers, which is scheduled to begin as a pilot program in 2012. This program will include visits to academic institutions, manufacturers, research organizations and health care facilities to give reviewers a better understanding of how medical devices are designed, manufactured and used.

“Providing our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for
medical devices,” Shuren said.

GE Healthcare Obtains FDA Clearance for CT System

GE Healthcare has received U.S. Food and Drug Administration (FDA) clearance for the Optima CT660, a compact computed tomography (CT) system.

“This next-generation CT system delivers on one of health care’s key challenges—generating precise clinical images and providing dose optimizing capabilities,” said Steve Gray, vice president and general manager of CT & Advantage Workstation for GE Healthcare. “Boosted by GE’s advanced low dose imaging technology, Optima CT660’s design and workflow enhancements also provide flexibility to facilities that may be constrained by space or resources—which aids healthcare professionals seeking to do more with less and best serve their patients’ needs.”

The Optima CT660 is the first CT system that is both ecomagination and healthymagination-certified, upholding two of GE’s global initiatives aimed at transforming healthcare delivery through innovation, partnerships and sustainability.

The system is scalable from 32 to 128 slices through various options and enables fast, high-performance imaging for patients at low doses. The system can be used in various clinical settings, including cardiac, neurological, emergency room and routine CT. The company claims the Optima CT660 will help healthcare professionals deliver personalized patient care through a combination of its dose-optimizing ASiR (Adaptive Statistical Iterative Reconstruction) technology, improved workflow features, and advanced applications for cardiovascular, oncology, neurology, CT angiography and other fields.

Medtronic Post-Approval Study for AAA is Underway

Medtronic Inc. has started its U.S. post-approval study of the Endurant AAA Stent Graft System, a medical device used to treat abdominal aortic aneurysms (AAA).

The first patient in the company’s study evaluating the long-term safety and effectiveness of the Endurant Stent Graft System (ENGAGE PAS) was enrolled in early September at Parkwest Medical Center in Knoxville, Tenn., by the site’s principal investigator, Christopher Pollock, M.D., chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center and associate professor of surgery at Harvard Medical School in Boston, Mass. The prospective, multi-center, single-arm study will enroll about 325 subjects and up to 25 U.S. sites, and has a primary endpoint of freedom from aneurysm-related mortality at five years after implantation of the stent graft.

The study augments Medtronic’s international ENGAGE registry, which was completed in April. The registry enrolled 1,266 patients over two years at 79 sites across 29 countries. In total, more than 1,800 patients treated with the Endurant AAA Stent Graft System will be followed out to five years as part of Medtronic’s global clinical program for the device. The program includes company-sponsored pre- and post-market studies conducted worldwide since November 2007, when the first in-human implant was performed in the Netherlands.

“From evidence comes confidence,” said Tony Semedo, vice president and general manager of the Endovascular Innovations business for Minneapolis, Minn.-based Medtronic. “The ENGAGE clinical program has produced a body of evidence on the Endurant AAA Stent Graft System that engenders confidence among physicians performing endovascular aneurysm repair. It stems from an enduring commitment to advancing the standard of care for AAA with innovative technology that reliably and predictably performs its intended function. We believe ENGAGE PAS, the U.S. post-approval study for our next-generation stent graft, will add to this unmatched dataset.”

The system was approved by the U.S. Food and Drug Administration in December 2010, and has since been used to treat more than 6,000 patients in the United States. Company executives claim it is the world’s leading stent graft.

The system consists of a flexible wire frame (stent) sewn onto a specially woven fabric tube (graft) that doctors use to create a new path for blood flow in the patient’s aorta, reducing pressure on the aneurysm and thus, lowering the risk of rupture.

Delivered through catheters inserted into blood vessels in the groin, the device conforms to a broad range of aortic anatomies, enabling physicians to offer endovascular aneurysm repair to more patients with AAA.

It is used for the endovascular treatment of infrarenal abdominal aortic and aorto-iliac aneurysms in patients with specific anatomical characteristics in the United States. Those characteristics include adequate femoral or iliac artery access, proximal neck length of at least 10 mm, infrarenal neck angulation of no greater than 60 degrees, and aortic neck diameter of 19 mm to 32 mm.

Stryker Nabs Concentric Medical for $135 Million; Legal Woes with Zimmer Continue

Life is filled with ups and downs—business life, in particular. Kalamazoo, Mich.-based Stryker Corp. has had its share of good and bad news recently.

On the “good” side, Stryker Corp. recently inked a deal for Concentric Medical Inc.—$135 million in an all-cash transaction. The acquisition, pending regulatory approval, is expected to close early in the fourth quarter.

Nabbing Concentric Medical provides Stryker with immediate entry into one of the fastest-growing segments of the interventional neurovascular space—ischemic stroke. Ischemic stroke represents the vast majority of all strokes. Industry data indicate that stroke is a leading cause of death and serious long-term disability in the developed world. Ischemic stroke represents over 85 percent of strokes and occurs when a blockage or clot develops in one of the arteries supplying blood to the brain.

Concentric Medical manufactures and markets minimally invasive devices that are endovascularly delivered to the brain to remove blood clots that cause ischemic stroke. Mountain View, Calif.-based Concentric launched its Merci Retriever in 2004. More recently, the company launched the Trevo Retriever in Europe in 2010. The Trevo Retriever is the first device to retrieve clots from the neurovasculature, according to the company. The device currently is being evaluated in a clinical trial investigating safety and efficacy.

“We believe Stryker is the ideal strategic partner for Concentric and combining Concentric with Stryker’s Neurovascular division will provide opportunities to accelerate the development of technology and clinical evidence and will allow the commercial expansion of Concentric’s ischemic stroke therapy globally. Our team is excited to be joining the Stryker organization,” said Maria Sainz, president and CEO ofConcentric Medical.

In the “not-so-good” column, Stryker’s legal battle with Zimmer Holdings Inc. over alleged talent poaching is escalating. Lawyers for both sides are feverish over the disclosure of documents in the case, with each company accusing the other of ignoring court-established deadlines. The case initially was filed in April.

In series of letters sent between Aug. 1 and Aug. 3, each side used colorful adjectives to describe the other’s position. Words such as “ludicrous,” “frivolous,” and “premature” were used, as well as phrases such as “just another attempt to waste this court’s … time,” “material misrepresentation of fact,” and“blatant gamesmanship.”

Magistrate Judge Patty Shwartz of the U.S. District Court for New Jersey denied Zimmer’s motion to sanction Stryker’s bid to extend discovery deadlines. She ordered both sides to deliver documents and related privilege logs by Aug. 11, according to court documents.

Stryker claims that Zimmer enacted a scheme to recruit its executives by “willfully and maliciously targeting and soliciting Stryker employees for employment at Zimmer,” according to the lawsuit.

“Using the recommendations of former Stryker Spine sales leaders it previously recruited, Zimmer first identified high-potential Stryker employees … and induced them to breach [their] contractual obligations by asking them to gauge their coworkers’ initial level of interest in an ‘opportunity’ with Zimmer,” the complaint states.

“Once these trusted ‘ringleaders’ planted the bait, Zimmer would make contact with the new Stryker recruits, offering significant salary increases and additional perks to capture the attention of employees who had no prior contact with or interest in working for Zimmer.”

The “ringleaders” then allegedly sought to pressure the recruits “by urging them not to ‘disappoint the team’ or ‘throw a wrench’ in the team’s plans to go to Zimmer en masse,” according to the suit.

Stryker claims the scheme resulted in the loss of almost two entire sales branches in Arizona and Las Vegas, Nev. The company anticipates the loss of millions of dollars in sales due to Zimmer’s alleged actions.

The battle with Zimmer isn’t Stryker’s only legal matter at the moment. The company also is embroiled in a case with former distributor BioInitiatives Inc. and DePuy Spine, and it is fielding complaints from patients about manufacturing problems with its pain pump.

Both Roseville, Calif.-based BioInitiatives and Warsaw, Ind.-based DePuy asked a California judge for an injunction barring Stryker from enforcing a non-competition clause in the now-expired deal with BioInitiatives, arguing it would violate California’s ban on non-compete agreements.

“Defendant Stryker Spine has recently engaged in activities to enforce comparable non-competition provisions towards other distributors,” state documents filed with the U.S. District Court for Eastern California. “Although confident that the non-competition provisions are void in California, defendant Stryker Spine’s conduct has caused plaintiffs to seek an order from this court confirming their position and avoiding the expected long and drawn out legal fight.”

The contract lapsed on Jan. 25, and BioInitiatives struck a deal with DePuy. The lawsuit aims to declare Stryker’s deal with BioInitiatives “void and unenforceable against California’s fundamental public policy,” and to prevent Stryker from taking any legal action to enforce the non-competition provision in the contract.

Meanwhile, Stryker continues to field patient complaints about its pain pump. Hundreds of lawsuits have been filed which allege that Stryker and other device manufacturers improperly are marketing pain pumps for post-operative joint pain, for which the devices are not approved by the U.S. Food and Drug Administration (FDA), according to the lawsuits. In 2009, the FDA issued a warning to healthcare providers against using pain pumps for “continuous intra-articular infusion of local anesthetics after orthopedic surgery.” Concern about the connection between pain pump use in joints and chondrolysis has been evident since the late 1990s.

Boston Scientific Takes Online Learning Initiative

Boston Scientific Corp. has launched its Neuromodulation Learning Institute (NLI), a clinical education program and online resource center for healthcare providers to enhance their knowledge and awareness of spinal cord stimulation (SCS) technology, procedures and techniques. The announcement was made during the annual meeting of the International Spine Intervention Society in Chicago, Ill. The Natick, Mass.-based company also is introducing an iPhone and iPad application that features surgical technique videos and access to an SCS textbook by Paul Kries, M.D. and Scott Fishman, M.D.

“The NLI offers in-depth instruction on techniques critical to successful patient outcomes with SCS,” said Thomas Simopoulos, M.D., director of the Interventional Pain Service at the Arnold Pain Management Center, Beth Israel Deaconess Medical Center in Boston, Mass., and assistant professor of Anesthesia at Harvard Medical School, also in Boston. “The new iPhone/iPad app is an excellent tool for training current and prospective pain physicians on spinal cord stimulation.”

The NLI offers various hands-on and Web-based learning tools via the company’s Precision Plus SCS System, which uses current delivered to the spinal cord to stop pain signals from being recognized by the brain.

“This training forum will benefit physicians and the patients who suffer from chronic pain by offering healthcare providers a comprehensive, single source of SCS information,” said Michael Onuscheck, senior vice president and president of Boston Scientific’s Neuromodulation Division. “The NLI is dedicated to providing a continuum of physician training that will broaden understanding of SCS and advance the quality of patient care.”

Study Says Tax Will Pummel Medical Device Sector Jobs

A proposed excise tax on the medicaldevice industry would result in the loss of 43,000 jobs and further impede medtech innovation, according to a new study released by the Advanced Medical Technology Association (AdvaMed).

The report by the Washington, D.C.-based organization outlined the full effect of the proposed tax on the industry. Study co-author Diana Furchtgott-Roth, senior fellow at the Manhattan Institute in New York, N.Y., and former chief economist of the U.S. Department of Labor, presented the analysis, which was compiled with Harold Furchtgott-Roth, senior fellow at the Hudson Institute in Washington, D.C.

The proposed 2.3 percent medicaldevice excise tax, set to begin in 2013, could cost the industry $2.67 billion in additional annual taxes and cut almost 11 percent of jobs, according to the study commissioned by AdvaMed.

“This is the time we want to encourage job creation in the United States, and adding an excise tax on the medical device sector will have the opposite effect,” Furchtgott-Roth said.

The effect on job creation is of primary concern—not only does the study estimate the loss of 43,000 jobs in the industry because of a lack of money for employment compensation, it also portends that U.S.- based innovation would take a huge hit.

“In terms of the burden of the ability to compete, I think [the tax] will hurt smaller firms the most,” said David Nexon, senior executive vice president of policy. The proposed tax must be paid by companies regardless of their net income; it is unlikely that start-up companies will have the means to pay the tax while researching and developing new products in their formative years.

“We need to look at the stream of jobs that will be created in the future,” Furchtgott-Roth said. “[Various studies] show that most new jobs are created within new firms, within the first five years. These firms might be discouraged from starting up altogether, and we would lose that potential stream of jobs.”

The tax also could discourage smaller firms from starting up in the United States and drive larger companies with vast financial resources to move operations overseas.

“This new tax burden could force companies that would otherwise never leave the United States to make difficult choices based on stark economic reality,” Stephen J. Ubl, president and CEO of AdvaMed, said in a statement.

Furchtgott-Roth pointed out that a trend in moving operations to other countries already has begun due to high taxes and stringent regulatory practices in the United States.

“This is especially important, because the medical device industry is one of the most innovative in the United States and creates well-paying jobs,” Furchtgott-Roth said.

The negative effects on employment could be felt around the country, but especially in Minnesota, Indiana, Massachusetts and Colorado, where a large number of people are employed by the medical device industry, the report noted.