The FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

“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 U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.

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

Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid diagnostic testing solutions, announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its QuickVue® RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.

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

ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin distribution of the new Propaq® M Monitor, a vital signs monitor for deployable military medicine that was developed to meet the special needs of military customers and air medical operations worldwide. Development of this product was a joint undertaking between the Department of Defense and a cooperative arrangement between Welch Allyn and ZOLL. Development was facilitated with grants from the U.S. Army Medical Research and Development Command.

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

Medtronic Inc.’s (NYSE:MDT) Integrity coronary stent received pre-market approval from the Food & Drug Administration and logged its first U.S. implantation.

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.

ReNu Medical, Inc., an environmentally safe and sustainable medical device reprocessor, announces that in August 2010, FDA completed a full Quality Systems inspection without noting any observations or deficiencies. This is the fifth consecutive inspection that ReNu Medical has demonstrated full compliance with the federal regulations for quality in medical device manufacturing and reprocessing.

“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

Authors
Jennifer Y. Dukart
Christin E. Garcia

This week, the United States Supreme Court agreed to review Matrixx Initiatives, Inc. v. Siracusano, a case presenting the question whether securities law plaintiffs must allege statistically significant evidence of harm to survive a motion to dismiss when bringing claims against drug companies for failure to disclose adverse event reports. Shareholders sued Matrixx, arguing that it violated § 10(b) of the Securities Exchange Act and SEC Rule 10b-5 by publicly affirming the safety of its nasal gel Zicam®, while knowing that 12 Zicam® users had reported a loss of their sense of smell. The district court granted Matrixx’s motion to dismiss the case, for failure to state a claim under the materiality or scienter (deceptive intent) requirements of the securities laws. The district court noted that the investors had alleged no data as to the reliability or accuracy of the user complaints, nor had they alleged that the complaints were statistically significant. The court cited Second Circuit decisions for the proposition that when shareholders seek damages for failure to disclose adverse event reports, materiality and scienter elements require, as a matter of law, allegations that the reports were statistically significant. See In re Carter-Wallace, Inc. Securities Litigation, 150 F.3d 153 (2d Cir. 1998); In re Carter-Wallace, Inc. Securities Litigation, 220 F.3d 36 (2d Cir. 2000) (both considering reports of aplastic anemia made in connection with the study or use of the anti-epilepsy drug Felbatol®). According to the Second Circuit, such a requirement ensures that the event may be caused by, rather than randomly associated with, the use of the drug.

The First and Third Circuits also have imposed statistical significance requirements in evaluating pleadings based on disclosure of adverse event reports. In New Jersey Carpenters Pension & Annuity Funds v. Biogen Idec Inc., 537 F.3d 35 (1st Cir. 2008), the First Circuit held that Biogen could not have intentionally misled investors about a risk that Tysabri® could cause opportunistic infections until the company knew there was something requiring disclosure, and that this knowledge could not arise from a few isolated reports without evidence of a causal relationship established through statistically significant findings. Id. at 44-53. Similarly, the Third Circuit held that American Home Products did not materially and intentionally mislead investors by failing to disclose all heart valve reports it had received about users of the diet drugs Pondimin® and Redux®, at a time when there was no statistically significant evidence establishing a serious health risk. Oran v. Stafford, 226 F.3d 275 (3d Cir. 2000).

Despite this authority, the Ninth Circuit Court of Appeals reversed the dismissal of claims in Matrixx Initiatives, stating that the district court’s reliance on the statistical significance standard was inconsistent with the Supreme Court’s rejection of bright-line rules related to materiality findings, and concluding that a “holistic” consideration of the complaint supported the necessary inferences that the information was withheld intentionally. Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167 (9th Cir. 2009).

Matrixx filed a petition for Supreme Court review. The question presented was phrased as follows: “Whether a plaintiff can state a claim under § 10(b) of the Securities Exchange Act and SEC Rule 10b-5 based on a pharmaceutical company’s nondisclosure of adverse event reports even though the reports are not alleged to be statistically significant.” In support of its certiorari petition, Matrixx cited precedent from the First, Second and Third Circuits as being squarely opposed to the Ninth Circuit’s refusal to require statistical significance allegations. On June 14, 2010, the Supreme Court granted the petition.

Drug and medical technology companies already must navigate an extensive set of rules about when and how to disclose adverse event reports to government agencies and incorporate adverse event information into product labeling. Hundreds of thousands of adverse event reports are received each year by FDA, and many of these reports do not offer complete, reliable or accurate information. In this context, a bright line rule introducing certainty and clarity about when these reports must be shared with investors could prove very useful.

The shaping of a disclosure rule, however, will require careful consideration. The rule should not overstate the importance of a calculation establishing significance, such that plaintiffs could allege that any statistically significant finding automatically establishes or implies materiality and intent. In other words, statistical significance may be necessary, but should not be sufficient to plead violations of the securities laws. Further, if the statistical significance test is adopted, the necessary showing requires clarification and should carry an important and relevant scientific meaning. The Internet offers many computer programs that can generate risk numbers without good statistical or clinical reason. The FDA’s recent decision to make additional safety information available publicly also could prove to be a source of statistical data that may not be scientifically meaningful but could be used by plaintiffs. And, as has been shown in other contexts, plaintiff counsel may adapt quickly to new pleading requirements.

Matrixx Initiatives presents an important opportunity for the adoption of stricter pleading standards in shareholder lawsuits alleging failure to disclose adverse event reports. zThe Court recently has strengthened other pleading standards, in ways that have had meaningful effects on civil litigation. It remains to be seen whether and how the Court will strengthen pleading requirements in this case. Whatever the Court’s holding, its decision likely will have important implications for companies that receive and evaluate adverse event reports.

Source: www.faegre.com

WEST CHESTER, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC – News), a medical device company and a leader in cardiac surgical ablation systems, today announced that it received clearance from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. The AtriClip system is designed to safely and effectively exclude the left atrial appendage. Initial launch in the United States is anticipated to begin later this month with full commercial release planned during the third quarter of 2010.

“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.

Medtronic Inc., the world’s largest medical device maker, spent about $1.07 million lobbying Congress in the first quarter, according to a recent disclosure form.

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

Abbott (NYSE: ABT) today announced positive six-month results from the first 45 patients enrolled in the second stage of the ABSORB trial, which was presented during the Late-Breaking Clinical Trials session at the EuroPCR 2010 conference. At six months, Abbott’s bioresorbable vascular scaffold (BVS) demonstrated strong results, with a low (4.4 percent) rate of major adverse cardiac events (MACE1) and no blood clots (thromboses). Abbott’s BVS also demonstrated an in-stent late loss rate of 0.19 mm. Late loss is a measure of vessel re-narrowing and looks at the change in the diameter inside the device between the time immediately following scaffold placement and at six months. The amount of re-narrowing tells physicians how effective a scaffold procedure was at keeping the blood vessel open.

“With each new data milestone, Abbott’s revolutionary BVS technology is one step closer to becoming a reality. The device achieved a six-month late loss rate of 0.19 mm. This finding suggests that the BVS may have the potential to treat a blocked vessel as effectively as a metallic drug eluting stent, with the added potential benefit of not leaving a permanent implant behind after the vessel is healed,”said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. “These extraordinary findings signal that Abbott’s disappearing scaffold may become the new standard of care for treating coronary artery disease.”

Abbott’s BVS, which is under clinical investigation in Europe, Australia and New Zealand and is not currently available for sale anywhere in the world, is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized and eventually resorbed by the body. Since a permanent implant is not left behind, a vessel treated with a BVS ultimately may have the ability to move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration, is one of the features that will make Abbott’s BVS unique in the treatment of coronary artery disease.

“In addition to achieving low late loss, Abbott’s bioresorbable scaffold demonstrated positive clinical outcomes, with no thrombosis and a low rate of adverse events at six months. These results are encouraging and add to the strong body of BVS data that has been gathered over the last several years,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “The ABSORB trial is a perfect example of Abbott’s dedication to developing technology that has the potential to revolutionize the way physicians treat coronary artery disease.”

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated site thrombosis rates – at 30 days; six, nine, 12 and 24 months; with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18 and 24 months. The next 56 patients in the second phase of the ABSORB trial will undergo imaging follow-up one year after their procedures, and all 101 patients in the second phase of the trial will receive follow-up imaging at two years.

Abbott’s bioresorbable technology delivers everolimus, an anti-proliferative drug. Everolimus is developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit treated site neointimal growth in the coronary vessels following vascular device implantation, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

1 MACE is a composite measure of key efficacy and safety endpoints and includes cardiac death, heart attack (myocardial infarction) and ischemia-driven target lesion revascularization.

Source
Abbott