The U.S. Food and Drug Administration (FDA) has given its approval for Boston Scientific Corp.’s Ion paclitaxel-eluting platinum chromium coronary stent system and Taxus Liberté paclitaxel-eluting coronary stent for use in patients experiencing an acute myocardial infarction (AMI), or heart attack.
According to the Natick, Mass.-based cardiovascular device giant, the devices are the only drug-eluting stent (DES) systems in the United States with an approved indication to treat patients with AMI.
The new indication, which accounts for approximately 10 percent of all coronaryinterventions, is a result of FDAreview of data from the paclitaxel (Taxus) clinical program and Horizons-AMI trial. In the global Horizons-AMI trial, 3,006 patients were randomized to receive either drug-eluting stents or bare-metal stents for the treatment of AMI, making it the largest randomized trial to study coronary stents in heart attack patients.
The Ion paclitaxel-eluting platinum chromium coronary stent. Photo courtesy of Boston Scientific Corp. |
“The AMI indication is a testament to our long-term commitment to innovation and leading clinical science in support ofadvanced DES technologies,” said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific. “Clinical data from the Horizons-AMI trial showed that, in patients with AMI, paclitaxel-eluting stents weresuperior in efficacy to bare-metal stents,significantly reducing clinical and angiographic restenosis compared to bare-metal stents, while demonstrating a comparable safety profile at three years.We are proud that our investments in randomized trials such as Horizons-AMI have led to theapproval of products to treat a broader range of patients with coronary artery disease.”
The company’s Ion stent system incorporates a platinum chromium alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.
The American Heart Association estimates that death by heart attack accounts for one out of every six deaths annually in the United States. There are more than 1.2 million new and recurrent cases of heart attack each year, with approximately 34 percent resulting in death.
Companies Join Forces to Create Fast, Flexible Point-of-Care Diagnostics
GE Global Research, the research development arm of General Electric Co. (GE) has been awarded a program through the Defense Advanced Research Projects Agency (DARPA) to develop a device that can diagnose the flu and other infectious diseases such as malaria, E. coli and salmonella at the point of care. In addition to making an accurate diagnosis, another goal of the device is to be readily adapted for new strains of diseases so that new diagnostic tests can rapidly be developed.
GE scientists will partner with InDevR, a biotechnology company in Boulder, Colo., that develops tools to assist in diseasediagnosis such as the flu and vaccine development as well. GE, with deep researchexperience in chemistry and world-classexperts in DNA and RNA analysis, willincorporate new materials and molecularbiology methods into a device developed by InDevR. The nearly $5.8 million in funding from DARPA for the project will result in the creation of at least seven new jobs at InDevR.
We are thrilled to be working with GE Global Research,” said Kathy L Rowlen, Ph.D., InDevR’s CEO and chief scienceofficer. “The partnership offers a powerfulcombination of InDevR’s strengths in virus identification and instrument development with GE’s global leadership in healthcare products, technologies and services. The DARPA contract will not only supportinnovative research to improve flu diagnosis, it will administer a healthy shot in the arm for Boulder’s economy in the form of new, high-paying technology jobs at InDevR.”
Erin Finehout, a lead engineer at GE Global Research and principal investigator on the DARPA project, explained that the flu can be diagnosed in the doctor’s office, but often, patient samples need to be sent out to a lab to confirm a diagnosis and provide more information about a patient’s condition.
“GE and InDevR intend to develop adevice that brings this analysis to the point of care at the doctor’s office, a remote military base, or the site of a humanitarian mission responding to a major healthcare pandemic,” Finehout said.
According to the Centers for Disease Control and Prevention, as much as 20 percent of the U.S. population will get the flu during flu season. Of that population, about 200,000 end up hospitalized for treatment. The hope is that faster, more accurate diagnosis of the flu and other respiratory viruses upfront will lead to improved patient treatment and a reduced number of severe cases.
GE and InDevR scientists are working to develop a device that is highly portable, easy to use and requires little training. This would allow a broader range of medical providers to operate the device and enable it to be used in clinical settings that would reach more people in need of care, experts from both groups noted. DARPA is interested in having a device that could be used in the field to help assess soldiers deployed in remote areas where access to care is limited. This device also is being targeted for use by medics sent out by the U.S. military on humanitarian missions and for disaster relief efforts.
The new device should be adaptable for recognizing new strains of the flu and other infectious diseases. Finehout explained this could be achieved if it can simultaneously analyze multiple types of biomolecules (DNA, RNA and protein) in a patientsample. Most diagnostic platforms are designed to work only with one of these types of molecules. This versatility will allow for a system that not only can be readily modified to recognize new strains, but also diagnose a wide variety of different diseases. This kind of adaptability and versatility is not possible in current devices on the market today.
Spine Firm Rolls Out FirstNew Product of 2012
K2M Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Santorini line of corpectomy cagesystems, which is designed to replace collapsed, damaged or unstable vertebral bodies due to trauma or tumor and provide anterior spinal column support.
The cages are manufactured from biocompatible PEEK polymer and, according to the company, allow for an unobstructed view of the post-operative fusion. They will be available as solid and expandable options in different sizes. The solid version offers an enlarged graft space, while expandable cages allow for in-situ expansion with a locking clip to secure the desired height.
“FDA clearance for Santorini is an important expansion of our complex spine product offering, particularly in the areas of trauma and tumor spinal surgeries,” said Eric Major, K2M’s president and CEO. “As the first addition to K2M’s portfolio in 2012, we’re proud to offer surgeons and patients new products that continue to highlight our commitment to treating the full spectrum of spine pathologies.”
Based in Leesburg, Va., K2M developsdevices for the treatment of complex spinal pathologies and minimally invasive procedures—with a focus on the treatment ofdeformity, degenerative, trauma and tumor spinal patients.
Navigation System from Philips Receives FDA OK
The U.S. Food and Drug Administration (FDA) has cleared a device made by Royal Philips Electronics that helps interventional cardiologists and cardiac surgeons to navigate during transcatheter aortic valve implantations. The product received 510(k) clearance last fall from the FDA.
The GPS-like HeartNavigator creates a3-D image from previously acquired two-dimensional computed tomography datasets that are reconstructed and overlaid with live images to provide real-time, 3-D insights. With one click, the heart automatically is segmented to reveal anatomical structures and landmarks. Virtual device templates can be used to assess and select the best device size and projection for the patient’s individual anatomy. Positioning of the catheter is visualized in real-time together with the placement and deployment of the artificial valve,according to the company.
“After the recent commercial introduction of transcatheter heart valves in the U.S., we are now able to offer heart valve implantations to a group of patients for whom the risks associated with open heart surgery are too high,” said Todd M. Dewey, M.D., cardiothoracic surgeon at Medical City Dallas Hospital in Dallas, Texas—the first American hospital to use the HeartNavigator in clinical practice.
“The implantation of a heart valve via a catheter has the advantage of being minimally invasive, but it demands high-quality imaging and precise navigation to ensure accurate positioning. Heart Navigator gives us a much better view of the procedure, which aids us in the preparation of the procedure as well as the execution.”
The HeartNavigator was introduced early last year in Europe, where transcatheter heart valves are more of a mainstay. Such valves have only recently been commercially introduced in the United States; as a result, the adoption of minimally invasive heart valve replacement is still in its early stages.
In Europe, where these valves have commercially been available since 2008, the market is more mature. Experts project that more than 13,000 minimally invasive valve replacements were performed in Europe in 2010, a number that has been growingannually at high double-digit growth rates. One physician estimated that nearly 900 transcatheter heart valve replacements have been performed at a clinic in Germany since the device became available in Europe.
“I plan all my cases with the HeartNavigator,” said H. Schröfel, senior cardiac surgeon at the Karlsruhe Heart Surgery Clinic in Karlsruhe, Germany. “I trust the measurements with HeartNavigator more than the measurements provided by the normal CT scan.”