Stryker Corp. (SYK) agreed to buy Boston Scientific Corp.’s (BSX) stroke-treating neurovascular businesses for $1.5 billion. The move lessens Stryker’s exposure to a slow-growing orthopedics market and marks a big, early step in Boston Scientific’s restructuring efforts.

The all-cash deal carries a hefty price tag following Wall Street speculation that Boston Scientific would sell its neurovascular business. To access an increasingly competitive, $900 million market, Stryker is buying a franchise with a long trend of shrinking sales and that was valued by some at up to $1 billion.

It represents a “big leap” into a new area for Stryker, and at a high cost, J.P. Morgan analyst Michael Weinstein said.

Meantime, the big price tag is good news for Boston Scientific up front, but that company is vacating a fast-growing market with high operating margins. Weinstein said management “will be hard pressed to find replacement assets that have meaningfully better long-term value potential.”

Boston Scientific plans to use half of the $1.2 billion in after-tax proceeds to retire debt and the rest for acquisitions. The company is engaged in a two-year restructuring plan likely to include more moves to rebalance a portfolio that relies heavily on growth-challenge heart devices.

Shares of the Natick, Mass., company recently traded up 0.6% to $6.30. Shares of Stryker, Kalamazoo, Mich., declined 1.1% to $50.35.

At issue is a business with catheter-delivered products used to treat strokes that already happened or unruptured brain aneurysms that could lead to strokes. In the latter case, coils are wound into blood-vessel bulges to block blood flow and try and prevent ruptures.

While the neurovascular market itself grows sales at a 9% to 10% clip, Boston Scientific hasn’t tapped into that potential for quite some time. Its neurovascular sales declined 3% to $348 million last year and slipped a steeper 7% in the third quarter. The delayed launch of a just-approved product has weighed on the company, as has increasing competition.

The competition has heated up amid a busy year for neurovascular deals. In recent months Johnson & Johnson (JNJ) bought Micrus Endovascular Corp. for $480 million, while Covidien PLC (COV) bought ev3 Corp. for $2.6 billion. Both deals mean Stryker will face sizable and well-funded competition. The market’s growth rate stands out in a time bigger device markets for cardiology and orthopedic implants are struggling to grow amid pressure from the economic downturn.

Stryker thinks the neurovascular business it’s buying will get back to “marginal growth” next year and market growth rates by 2012, Chief Financial Officer Curt Hartman said. Stryker is retaining that business’ president and likes the management team, but said the business was hurt by broader quality challenges Boston Scientific dealt with in recent years.

“We think they are re-poised for growth now,” said Stephen MacMillan, Stryker’s chairman and chief executive, on a conference call Thursday.

This deal follows long-running questions about how Stryker will deploy its sizable cash war chest. The company has long talked about using cash for acquisitions, and has done smaller-scale deals, but this one marks the biggest transaction since it spent $1.65 billion to buy Pfizer Inc.’s (PFE) orthopedics division 12 years ago.

Stryker posted total sales of $6.72 billion last year, while Boston Scientific posted sales of $8.2 billion, with neurovascular accounting for 4.3%.

Stryker, a big competitor in the $12 billion market for replacement hips and knees, has been stung by eroding growth there caused by patients deferring surgery due to lost jobs or worries about taking long stretches off work for recovery. But Stryker also has a business for hospital and surgical devices, like stretchers and medical scopes, which has grown fast lately and offset the weaker orthopedic business.

MacMillan said the neurovascular purchase is not a comment on orthopedic-market prospects, and said Stryker was perusing neurovascular opportunities before orthopedics hit a rough patch. But he also highlighted the fact the deal further diversifies the company’s product offerings.

The deal, expected to close in December, includes $100 million to be paid when certain milestones are met, such as commercialization of new “Target” coils and the transfer or separation of manufacturing plants. Stryker exects the deal to be breakeven or slightly accretive for per-share earnings in 2011, while Boston Scientific anticipates 4-6 cents of dilution next year.

Source: Wall Street Journal
-By Jon Kamp (Matt Jarzemsky contributed to this article.)

Boston Scientific Corporation (NYSE: BSX) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its Advanix™ Biliary Plastic Stents for the treatment of biliary strictures, including biliary stone disease, benign biliary strictures, and suspected and confirmed malignancies in the biliary system. The product is now available in Europe and other international markets; the Company plans to launch it in the U.S. this quarter.

Endoscopic therapy, specifically with stent placement, has gained acceptance as a first line of treatment for biliary strictures and offers a less-invasive alternative to surgery. Results from a published study of patients with post-operative benign bile duct strictures demonstrated that stenting has similar long-term success rates and lower early complication rates compared to surgery(1).

The Advanix Biliary Stent is designed to accommodate a range of clinical requirements and includes features for improved deliverability in navigating tortuous anatomy. It employs the NaviFlex™ RX Delivery System, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement. The pre-loaded stent within the delivery system enables physicians to reposition the stent, helping to ensure accurate placement. The highly visible guidewire exit port allows for easier manipulation during the procedure.

“The Advanix Biliary Stent System features significant developments in plastic stent technology,” said Stuart Sherman, M.D., Clinical Director of Gastroenterology and Hepatology, and Director of the ERCP(2) program at Indiana University Medical Center in Indianapolis. “Improvements in design provide greater procedural control and efficiency while navigating tight strictures in the bile ducts, facilitating stent placement and removal. The thin wall and increased inner diameter of the stent may provide extended patency of the duct, which could improve treatment outcomes.”

“Boston Scientific remains committed to delivering innovation and leadership in endoscopic stent technology,” said Michael Phalen, Senior Vice President, and President of Boston Scientific’s Endoscopy Division. “The Advanix Biliary Stent System represents the latest advances in plastic stent design, enabling physicians to more efficiently and effectively treat blockages in the bile duct. In addition, it strengthens our broad stent portfolio and provides another solution for the ERCP suite.”

Benign strictures in the bile duct are typically caused by prior surgical procedures, biliary stones or chronic pancreatitis, a disease in which digestive enzymes begin to break down and attack the pancreas. Chronic pancreatitis is extremely painful and in severe cases, can lead to infection, shock and respiratory failure. The most common cause of malignant biliary obstruction is pancreatic cancer, which is rarely diagnosed in the early stages, and is the second most common cause of death among gastrointestinal cancers. Other causes of malignant biliary obstructions include bile duct, liver and gallbladder cancer.

The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences.

Source:
Boston Scientific

Medtronic, Inc. (NYSE:MDT) announced that it has entered into an agreement to settle existing U.S. lawsuits relating to its Sprint Fidelis® family of defibrillation leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949) that were the subject of a field action announced on October 15, 2007.

Under the terms of the agreement, Medtronic has agreed, subject to certain conditions, to settle U.S. lawsuits and claims pending as of October 15, 2010 for a total payment of $268 million. The payment includes an amount for attorneys’ fees and administrative expenses. The parties will file joint requests to terminate the Multi-District Litigation (MDL) and Minnesota state court proceedings related to the Sprint Fidelis leads and to dismiss the plaintiffs’ appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals. The parties will also request dismissal of other Fidelis-related cases throughout the country. Medtronic can cancel the agreement if certain conditions are not met, and the agreement can be terminated by either party if the MDL proceedings are not terminated.

The cases in the settlement are those arising in the United States from the October 15, 2007 Sprint Fidelis field action, including cases currently filed either in the MDL or in state courts. All settling plaintiffs must satisfy any insurance claims and subrogation interests of Medicare or Medicaid from their settlement payments. No additional sums for these cases will be paid by Medtronic for third-party claims or attorneys’ fees.

The settlement is a compromise of disputed claims, and the parties have not admitted any liability or the validity of any defense in the litigation. Medtronic expects to record the Sprint Fidelis lead litigation settlements as a special charge in its second fiscal quarter ending October 29, 2010.

Source:
Medtronic

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

Investigators reported results of SORT-OUT IV, comparing Cordis Corporation’s CYPHER(R) Sirolimus-eluting Coronary Stent and Abbott’s XIENCE V ® Everolimus-eluting Stent in the primary endpoint of MACE (major acute coronary events) at nine months. These findings were presented at the TCT annual meeting, (TCT 2010)held last week in Washington DC. This study adds to the unmatched body of safety and efficacy data on the CYPHER® Stent with this comparison to the more recently approved XIENCE V® Stent in a contemporary setting.

“The SORT OUT consortium has used CYPHER® Stent as the comparator in a number of studies and to date, no newer stent has proven a benefit over CYPHER® Stent in terms of safety or efficacy,” said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation. “The safety and efficacy of the CYPHER® Stent in this real-world randomized study reinforce the excellent sustained clinical outcomes consistently seen over the last 10 years.”

The large randomized trial SORT OUT IV included more than 2,600 patients across a wide range of lesion and patient complexity. The study was designed to test whether the XIENCE V® stent is non-inferior to the CYPHER® stent. Both drug-eluting stents performed better than planned for the composite endpoint of MACE (4.9 % for XIENCE V® Stent vs. 5.2% for CYPHER® Stent); these data support the non-inferiority of the XIENCE stent over the CYPHER stent (non-inferiority p=0.01) . There was no statistically significant difference in key markers of safety including the incidence of cardiac death (1.9% for XIENCE V® Stent vs. 1.4% for CYPHER® Stent: p=0.31), myocardial infarction, (1.1% for XIENCE V® Stent vs. 1.4% for CYPHER® Stent: p=0.48), or definite or probable stent thrombosis (0.9% for XIENCE V® Stent vs. 0.9% for CYPHER® Stent: p=0.83).

“The SORT OUT IV trial demonstrates that both drug eluting stents perform extremely well,” said Rogers. “The unique design characteristics of the CYPHER® Stent continue to make it an essential treatment option for today’s interventional cardiologists.”

About the CYPHER® Stent

The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.

*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.

**The third party trademarks used herein are trademarks of their respective owners.

Source:
Cordis Corporation

Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced that the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) unanimously voted that Hologic’s Pre-Market Approval (PMA) demonstrated both the effectiveness and safety of the Company’s Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system, “Selenia Dimensions 3-D.” In addition, the Panel voted in favor that the benefits of this new technology outweigh the risks.

Following today’s FDA Panel meeting, which was held in Gaithersburg, Maryland, Hologic will work with the FDA on next steps for approval of its 3-D digital mammography system. While the Panel’s favorable vote is advisory in nature, the FDA will consider it in its final review of Hologic’s PMA application for the Selenia Dimensions tomosynthesis system.

“Our Selenia Dimensions 3-D technology marks tremendous progress in the early diagnosis of breast cancer,” said Jay A. Stein, Co-Founder and Chief Technical Officer. “The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions. I speak for all of Hologic in voicing great satisfaction that the FDA Panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality.”

Hologic’s Selenia Dimensions 3-D digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a two-dimensional (2-D) image, breast tomosynthesis produces a three-dimensional image. We believe our multicenter clinical study has demonstrated that compared to 2-D digital mammography alone, 3-D digital tomosynthesis used in combination with 2-D digital mammography has the potential to reduce recall rates and improve cancer detection.

Hologic’s Selenia Dimensions 3-D digital mammography tomosynthesis system is presently commercially available outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional only system that can be upgraded to do breast tomosynthesis (3-D) imaging when and if the product is approved by the FDA.

“We are extremely pleased with the outcome of today’s FDA Panel meeting,” said Rob Cascella, President and Chief Executive Officer. “Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2-D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection – fast, high-quality 2-D and 3-D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women’s lives.”

Forward Looking Disclaimer

This News Release contains forward-looking information that involves known and unknown risks and uncertainties, including statements about the outcome of the Panel review of Hologic’s Selenia Dimensions digital breast tomosynthesis system, and the anticipated benefits of that system. The Panel review is only one step in the FDA’s review process and its vote on safety and efficacy is advisory only. Hologic is unable to predict the outcome of the FDA’s final review of its PMA. There can be no assurance that the FDA would approve Hologic’s system on a timely basis, if at all. In addition, even if approved, the FDA could impose conditions to such approval that would significantly limit the use or commercialization of the system. Moreover, there can be no assurance the system will achieve the anticipated benefits described herein, or that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Among other things, newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated. The risks and uncertainties included above are not exhaustive. Other factors that could adversely affect the Company’s business and prospects are described in the Company’s filings with the Securities and Exchange Commission. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such data or statements are based.

Source: Hologic, Inc

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

Cardinal Health announced that Baylor Health Care System has selected the company as its preferred provider of medical product supply chain services for its hospitals, specialty facilities and other care locations.

Under the terms of the agreement, Cardinal Health will provide medical product supply chain services to Baylor’s network of health care facilities, with a goal of reducing inventory costs and improving safety for patients.

“Baylor was seeking an organization with a proven track record of helping leading health systems improve the efficiency and safety of medical products distribution across operations,” said Pamela L. Scott, vice president of Supply Chain Management for Baylor. “Focusing on improving our medical supply chain capabilities will improve how we order, stock and safely deliver medical products across our facilities, which ultimately benefits our patients.”

Leveraging its supply chain expertise, Cardinal Health will support Baylor Health Care System in its provision of full-range inpatient, outpatient, rehabilitation and emergency medical services.

“By focusing on an efficient supply chain, we’ll enable Baylor to focus on delivering patient care,” said Mark Rosenbaum, Chief Customer Officer at Cardinal Health. “We work continuously to improve efficiencies across the chain of health care, and we’re proud to provide the products and integrated, end-to-end services that will help Baylor Health Care System provide safe, quality care.”

Source: Cardinal Health