Terumo Buys Onset Medical
Terumo Medical Corp., the U.S. subsidiary of the Japanese firm Terumo Corp., has purchased Irvine, Calif.-based Onset Medical Corp., a maker of sheath technology used in minimally invasive cardiology and urology procedures.
Terms of the deal were not disclosed.
Onset’s sheaths, using what the company calls its Controlled Deployment Technology (CDT), are designed to provide surgeons minimally invasive surgical access to perform procedures such as valve repairs or implants, or kidney stone removals, thus limiting the risk of excess trauma or other complications. Terumo already has its own line of sheaths and other access devices. However, according to Terumo leadership, there isn’t any overlap in current product lines, and the acquisition is a good fit because Onset’s products are additive to Terumo’s current product line.
Onset will become part of Terumo Medical Corporation as part of the company’s Interventional Systems (TIS) business unit, where the CDT platform will add to Terumo’s line of entry-site management and lesion access technologies. Onset will remain in California. The company is not planning any job cuts at this time.
Terumo customers will have access to Onset’s complete product lines.
Onset’s SoloPath Balloon Expandable Transfemoral and Transseptal Catheters’ expandable and collapsible sheath technology provides TIS entry into the global structural heart and aneurysmal repair markets, providing an access platform for complex, large-bore procedures including transcatheter aortic valve implantation, thoracic endovascular aortic/aneurysmrepair, and endovascular aneurysm/aortic repair. The Pathway Balloon Expandable PCNL Sheath and the Balloon Expandable Ureteral Access Sheath are tools to perform procedures such as percutaneous nephrolithotomy in the removal of large kidney stones.
“We welcome Onset to the Terumo family and look forward to providing our customers with current and future products based on the CDT platform, which represents a tremendous complement to our overall value proposition as the leaders in entry site management and lesion access,” said James Rushworth, senior vice president and general manager of Terumo Medical Corporation.
Rushworth also will become president of Onset Medical.
“CDT literally changes the way physicians enter the vascular system and manage the access site, while allowing them to achieve easier, safer access to the target lesion in a variety of clinical applications,” he added. “This strategic acquisition reinforces our commitment to pursuing unique technologies that meet the specialized needs of our customers and contribute to better outcomes for their patients.”
Onsite executives said the Terumo offers seemed like a good fit.
“When Terumo approached us, it quickly became clear that they were the established leader in entry site management and the best company to commercialize our sheath technology on a global scale,” said Joseph Bishop, vice president and chief operating officer of Onset Medical Corporation. “It is gratifying to know that our unique devices will immediately strengthen their core capability and will be featured prominently among other class-leading technologies that drive better patient outcomes.”
Terumo Interventional Systems (TIS) offers a full line of guidewires, catheters, introducer sheaths, guiding sheaths and embolization products for use in different interventional procedures.
Terumo Medical’s U.S. headquarters is inSomerset, N.J.
CareFusion’s Alaris Infusion Pump Meets NIST Standards for Data Encryption
In a an increasingly wireless world, healthcare data “floating through the air” is among the most dangerous of information transmitted wirelessly.
Along those lines, CareFusion Corp.reports that its Alaris infusion system is the “first and only” such system to receive a new data encryption certification nowrequired for infusion devices operating on U.S. Department of Veterans Affairs (VA) hospital networks. The certification, known as Federal Information Processing Standard (FIPS) 140-2, certifies that Alaris is compliant with stringent wireless encryption and physical security requirements set by the National Institute of Standards and Technology (NIST).
The NIST FIPS program defines various levels of physical and data encryption security that devices must meet in order to operate on federal wireless networks. The FIPS 140-2 standard is designed to protect sensitive but unclassified information, such as electronic health records. CareFusion’s Alaris Systems Manager facilitates wireless communications between the pump system and a hospital’s wireless network to provide an enterprise-grade, secure deployment architecture.
“We’ve been helping the VA network of hospitals deliver quality care for many years,” said J.C. Kyrillos, senior vice president and general manager of Infusion Systems at CareFusion. “This federal certification underscores CareFusion’s commitment to advanced technology that is designed to protect patient safety and confidentiality. In the event this wireless security requirement extends to other Federal care providers, we are well positioned and ready to support provider needs.”
CareFusion is based in San Diego, Calif.
Medtronic Rolls Out New AAA Stent in Europe
Medtronic Inc. has the green light in Europe for its Endurant II stent graft system for abdominal aortic aneurysm (AAA). With its recent CE mark the company is ready for the international rollout of the device, which according to the company, expands options for physicians outside the United States to treat patients with AAA through a minimally invasive technique called endovascular aortic repair. AAA is a weakening or bulge in the segment of the aorta, the body’s main artery that crosses through the abdomen. AAA often is called a “silent killer” because it rarely causes symptoms until it ruptures, which usually causes death.
Developed in collaboration with more than 250 physicians from around the world, the new system encompasses the clinical performance of the first-generation Endurant stent graft platform (approved in the United States in December 2010), while adding design features that enhance the device’s ease of use, company officials noted.
According to a press release, the Endurant II AAA stent graft system adds three enhancements to the Endurant line:
• Beginning at the point of access, the new lower-profile delivery system––with 35 percent extended hydrophilic coating forenhanced access to challenging anatomies––allows the 28 mm-diameter bifurcated segment (the most commonly used size) to fit inside an 18 French outer diameter catheter (down from 20 French with the original device);
• Two added contralateral limb lengths (156 mm and 199 mm) enable more configuration options requiring fewer total pieces; and
• The radiopacity of the distal end of the bifurcated segment’s contralateral gate has been improved to enhance visibility and aid with limb insertion, placement and deployment.
“The Endurant II AAA Stent Graft System will confer considerable confidence to vascular surgeons who use EVAR to treat even the most complex AAAs,” said Hence Verhagen, professor and chief of vascular surgery at the Erasmus Medical Center in Rotterdam, the Netherlands. “Building on the exceptional clinical outcomes of the original system, which has significantly increased the applicability of EVAR, Endurant II offers an even better user experience, which will benefit even more patients whose AAAs are detected before rupturing.”
Verhagen, who led the European clinical trial of the originalEndurant Stent Graft that contributed to that device’s approval, was the first physician to successfully use the new system since it received the CE mark.
In countries where the Endurant II has CE mark, the device is indicated for the endovascular treatment of abdominal aortic aneurysms in patients with a proximal neck ≥ 10 mm in length with ≤ 60-degree infrarenal and ≤ 45-degree suprarenal angulation and in patients with a proximal aortic neck ≥ 15 mm in length with ≤ 75-degree infrarenal and ≤ 60-degree suprarenal angulation.
Officials at Minneapolis, Minn.-based Medtronic expect Endurant II to receive U.S. premarket approval this year.
Abbott Labs Plans Additional Layoffs
Late last month, Abbott Laboratories unveiled plans to lay off 700employees as part of its ongoing restructuring efforts.
Most of the layoffs, according to the company, will affect employees who manufacture the company’s heart stents and diagnostic tests. Abbott has seen a decline in stent sales, ahead of the expiration of a supply agreement with sector rival Boston Scientific Corp. Abbott currently sells a version of its Xience stent to Boston Scientific, which pays a 40 percent royalty on sales. Boston Scientific recently replaced that device with its own in-house stent, Promus Element.
Roughly 300 of the eliminated positions will come from the company’s stent business in Southern California. Less than 200 others involve the company’s diagnostic business in Lake County, Ill. Additional reductions will impact the company’s pharmaceutical manufacturing operation in Puerto Rico.
News of the layoffs came several hours after Abbott reported a 12 percent increase in fourth-quarter profit. In October, Abbott surprised investors and the medical technology community with the announcement that it would spin off its branded drug business.
Cook Medical and Cardinal Health Ink Distribution Deal
Cardinal Health Inc. and Cook Medical Inc. have agreed to a two-year, exclusive arrangement for the North American distribution of Cook Medical central venous catheter (CVC) sets with Cardinal Health Presource customizable procedural kits.
Under the agreement, Cardinal Health and family-owned Cook Medical customers now are able to customize components of their CVC procedural kits. The kits can include either uncoated or Cook Spectrum CVC sets, which include power-injectable catheters. The partnership enables acute care providers to maximize value and minimize waste by providing a cost-effective means to decrease the number of supplies they need to supplement standard CVC procedural kits, according to a release issued by both companies.
“We’re thrilled to partner with Cardinal Health, an industry leader in custom kitting, to expand access to Cook Medical’s CVC sets for vascular access professionals,” said Dan Sirota, vice president and business unit leader of Cook Medical’s Critical Care and Interventional Radiology divisions.
“Improving patient care and lowering health care costs are of utmost importance to hospitals. We remain committed to offering solutions that streamline processes for clinicians and empower them to provide top-quality patient care.”
Bloomington, Ind.-based Cook Medical’s Spectrum catheters include the antibiotics minocycline and rifampin and meet the newly released 1A recommendation from the Centers for Disease Control and Prevention (CDC) for reducing catheter-related bloodstream infections (CRBSIs) if maximal sterile barrier precautions haven’t helped a facility reach its [infection prevention] goal. An estimated 78,000 patients are infected with potentially fatal CRBSIs in the United States every year, with an average cost estimated at $16,550 per infection, according to the CDC. Spectrum catheters have been shown to be five times less likely to produce infection than process alone, according to the Journal of Clinical Oncology.
“Cardinal Health focuses on developing partnerships that deliver innovative solutions that help make it easier for our customers to deliver high quality care,” said Lisa Ashby, president of category management at Dublin, Ohio-based Cardinal Health. “Our relationship with Cook Medical is a great example of the kinds of partnerships our customers value—those that promote best practice standardization with superior quality products.”
St. Jude Reports Good News from FAME II Trial
Positive results from the FAME II clinical trial bring an end to the study’s enrollment. The Independent Data Safety Monitoring Board (IDSMB) recommended that the trial, conducted by St. Jude Medical, be stopped because it has found a “highly statistically significant reduction in the need for hospital readmission and urgent revascularization when fractional flow reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease,” according to a release issued by the company.
FFR is a physiological index used to determine the hemodynamic severity of narrowings in the coronary arteries, and is measured using St. Jude Medical’s PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the blood flow to the heart muscle (calledischemia), and guides the cardiologist indetermining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.
The goal of the trial is to further study the role of FFR in the treatment of stable coronary artery disease by comparingpercutaneous coronary intervention (PCI) guided by FFR plus optimal medical
therapy (OMT) to OMT alone.
During coronary catheterization, a catheter is inserted into the femoral (groin) or radial arteries (wrist) using a sheath and guidewire. FFR uses a small sensor on the tip of the wire (commonly a transducer) to measure pressure, temperature and flow to determine the exact severity of the lesion. This is done during maximal blood flow (hyperemia), which can be induced by injecting products such as adenosine or papaverine. A pullback of the pressure wire is performed, and pressures are recorded across the vessel.
There is no absolute cutoff point at which FFR becomes abnormal; rather, there is a smooth transition, with a large grey zone of insecurity. In clinical trials however, a cutoff point of 0.75 to 0.80 has been used; higher values indicate a non-significant stenosis, whereas lower values indicate a significant lesion.
The DSMB recommended that St. Jude Medical stop patient enrollment due toincreased patient risk of major adversecardiac events among patients randomized to OMT alone compared to patients randomized to OMT plus FFR-guided PCI. In particular, patients receiving OMT alone experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization, and the DSMB determined that this difference was highly unlikely to change with inclusion of more patients, the company reported. The data currently reflect no observed difference in the rates of death or heart attack.
The FAME II trial may provide new insights about the benefits of coronary intervention and answer questions raised by the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, which demonstrated no difference in the outcomes between PCI plus OMT compared to OMT alone. However, the COURAGE study did not require use of St. Jude’s PressureWire FFR measurement technology. The FAME II trial will continue following patients currently enrolled according to the trial protocol and will not enroll any new patients. The trial randomized 1,219 patients with stable coronary artery disease in 28 centers inEurope, the United States and Canada.
“The original FAME trial demonstrated that FFR guidance improves outcomes in patients with stable coronary artery disease and two or three vessel disease. Today, FAME II confirms that PCI is beneficial for patients with one, two and three vessel disease whose ischemia has been documented by FFR,” said Frank Callaghan, president of St. Jude Medical’s Cardiovascular Division. “Due to the statistically and clinically compelling differences in the number of patients returning to the hospital for an urgent revascularization procedure—which can be considered a surrogate for a repeat heart attack or death —we support the recommendation of the DSMB and the trial’s Steering Committee. We expect the data will continue to reveal the important role that FFR plays in developing an optimal treatment strategy.”
Data will be published as information is analyzed, with initial results expected to be presented later this year.
St. Jude’s main competition in the FFR space is San Diego, Calif.-based Volcano Corp. Despite the competition in this space, the good news for St. Jude could also be perceived as a good thing for
Volcano and its FFR product line.