CD&Ds

Boston Scientific (Natick Massachusetts) is taking a huge leap ahead of the competition with the FDA approval of its Taxus Liberte Atom paclitaxel-eluting coronary stent system. The company said that, with this approval, it has a DES for use in vessels as small as 2.25 mm in diameter – something it says no other company has on the market.

This is the second generation of the Taxus Liberte, which is a little smaller than most of Boston SCi's other DES offerings.

"This is a unique space that we occupy," Jeff Lemaster, VP of stent marketing for Boston Scientific, told Cardiovascular Devices & Drugs. "No one else offers a DES in this size."

But what does size matter? n this case, almost everything, according to Lemaster. The smaller size reduces the chance of restenosis, a painful side effect that seems to occur after some DES are implanted.

"This is just bettering terms of efficacy and safety," he said.

Last year's launch of the Taxus Express Atom Stent offered an alternative treatment choice for patients with small vessels who will now have the additional option of the Taxus Liberte Atom stent.

Data from numerous clinical studies have shown that an estimated 10% of patients undergoing percutaneous coronary interventions have small vessels (<2.5 mm). Until recently, many physicians were inclined to implant bare-metal stents in these patients since they were the only approved stenting option for small vessels. The only other option was angioplasty.

The Taxus Liberte Stent features design improvements over the company's first-generation Taxus Express Stent, including thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.

On top of being an improvement over past generations, the company said that this product offering will be able to sustain itself and go without much competition from other med-tech companies for quite some time.

Lemaster told CD&D that although Medtronic (Minneapolis), Johnson & Johnson (New Brunswick, New Jersey) and Abbott (Abbott Park, Illinois) all had drug-eluting stents, the smallest size that these companies manufactured was 2.5 mm.

"We measure our market share at 6% – there is about another 2% we can glean from the approval of [the Liberte Atom Stent] because nobody can compete in that market. J&J has been trying to get approval for 2.25 mm for two or three years and we've heard nothing further about them pushing such a goal. Abbott is pursuing the 2.25 mm – but we don't anticipate any other company getting clearance for 2.25 mm until about early 2012 or 2013."

That amount of lead time would give Boston Sci a significant amount of time to establish the brand.

Despite published reports attacking the safety and efficacy of DES, Boston Sci said it remains confident that the market is strong for these devices.

The company said on Wednesday that DES as a whole was on an upward swing and that the numbers of patients using DES have increased.

Taxus stents have been evaluated by the industry's most extensive randomized, controlled clinical trial program, Boston Sci said, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries.

To date, nearly 11 million Boston Scientific stents have been implanted globally; making them the world's most frequently used stents.

The company said it expects to expand its stent portfolio later this year with the first 38 mm-long DES, the Taxus Liberte Long Stent, which is under review by the FDA.

Elsewhere in the product pipeline:

• BioCardia (San Carlos, California) has introduced a new tool designed to help physicians refine minimally invasive treatment of peripheral artery disease (PAD). It could result in better outcomes for many of the 12 million Americans who suffer from an accumulation of plaque in arteries, which reduces blood flow. Clearing out that plaque has, for years, been performed via angioplasty that makes use of a catheter to reach the blockage. Even though those catheters are considered flexible, they aren't always ideal for the curves of the human anatomy. Morph AccessPro has received FDA 510(k) clearance as a tool to refine this procedure. Surgeons currently use multiple preshaped catheters and scrape the soft curves up and down the aorta. The Morph AccessPro allows surgeons to use a single straight catheter. When they reach the target lesion, it deflects and takes on the needed shape in real time. "Better manipulation of a catheter in the vasculature could result in better outcomes," said CEO Peter Altman, PhD. "It's a steerable introducer that gives a clinician the advantage of a deflectable catheter that can take the shape of any geometry," Altman said. "Because it can be shaped in the patient, it can have better back-up support than other catheters that are very soft and floppy at the distal end. It can provide for customization of the distal shape of the presenting anatomy."

• EaglePicher Medical Power (Plano, Texas) reported the introduction of its enhanced Lithium Carbon Monofluoride (Li/CFx) battery technology with end-of-life capability superior to currently available products in the market. The technology includes a new Elective Replacement Indicator (ERI) / End of Life (EOL) Indicator to accurately predict battery depletion six months in advance, potentially requiring fewer replacement surgeries over time. The enhanced Li/CFx battery chemistry provides higher energy density for use in a variety of implantable applications including telemetry-capable pacemakers and ICDs, neurostimulation devices, drug pumps, body fluid pumps and monitors.

• Lantheus Medical Imaging (North Billerica, Massachusetts) said that it has completed patient enrollment of CaRES (Contrast Echocardiography REgistry for Safety Surveillance), the first, multicenter Phase IV observational registry that evaluates the use of ultrasound imaging agents in routine clinical practice. The patients in the study required Definity Vial for (Perflutren Lipid Microsphere) injectable suspension-enhanced echocardiography because of a previous suboptimal, unenhanced echocardiogram. In patients with suboptimal echocardiograms, Definity enables physicians to visualize the borders of the heart more clearly.

• Lantheus Medical Imaging (North Billerica, Massachusetts) said that the company's leading imaging agent, Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), was used in a recently completed five-year study examining appropriate treatment regimens for patients with type 2 diabetes and coronary artery disease. Cardiolite is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling).

• MedApps (Scottsdale, Arizona) said it has been granted FDA clearance for its expanded, flexible telehealth solution. The MedApps system is designed to link patients, families and healthcare professionals by providing a convenient way to remotely collect, transmit, store and report timely and accurate health information – anywhere. The system features the HealthPAL, a small portable personal health device, to collect and transmit readings from glucose meters, blood pressure monitors, weight scales and pulse oximeters. Timely health readings from these devices are useful in maintaining wellness regimens and can assist clinicians in their treatment of patients with chronic diseases.

• Royal Philips Electronics (Andover, Massachusetts) introduced its microTEE, which it calls "the world's smallest transesophageal echocardiography (TEE) transducer for cardiac imaging of neonatal patients." As part of the latest Vision release for the Philips iE33 intelligent echocardiography system, the microTEE transducer provides pediatric cardiologists with a diagnostic tool for imaging the hearts of newborn patients. Philips microTEE is being showcased at the 20th annual American Society of Echocardiography meeting in Washington and will be available for sale globally this summer. Philips said that due to the larger size of previously available pediatric TEE transducers, small babies have been impossible to image during critical cardiac catheterization or surgical procedures. As a result, high-risk procedures have been done routinely on these tiny patients without transesophageal echocardiography images available to the interventionalist or surgeon. "The microTEE probe is a major advance in our ability to provide intra-operative cardiac imaging in newborn babies and infants," said Dr. Girish Shirali, MD., director of pediatric echocardiography at Medical University of South Carolina (MUSC) Children's Hospital. "We are delighted with the image quality, and the miniaturization of the probe has already proven invaluable to our pediatric interventionalists in high-risk cath lab procedures. Finally, our smallest and sickest patients can be imaged intra-operatively just like everyone else." The microTEE transducer is roughly one-third the size of previous pediatric TEE transducers, allowing physicians to 'turn on the lights' for the first time for their tinier patients and providing the images they need during interventional procedures. The microTEE also is entering trials for adult patients requiring TEE imaging, but who have difficulty tolerating standard TEE probes.

• Shape Medical Systems (St. Paul, Minnesota) is offering a much simpler and less-intensive way of testing for measuring ventilation parameters for patients who have suffered from cardio illness. The Shape HF Cardiopulmonary Testing System was given FDA approval at the end of March and objectively measures CRT response in real time while the patient is exercising, according to Shape Medical. Objectivity is the key selling point of the device. "Typically patients are given questionnaires or surveys – more subjective means to test for CRT responses," Clarence Johnson, president/COO of Shape Medical told MDD last month. As the patient exercises at a steady state heart rate, the physician adjusts therapy settings every two minutes, enough time for the adjustments to be reflected in breathing physiology. At the end of the test, during which four to five therapy settings are tested, the Shape-HF System uses a proprietary computer algorithm to rank the physiological response to exercise at each setting. The physician then reviews the results and chooses the therapy setting he or she believes is most appropriate for the patient. The exercise includes walking on a treadmill at a very low intensity of one mile per hour with the treadmill set at a 2% grade. "Other methods have proven to be very difficult for patients," Johnson said. "The Gas inhalation test for example is very difficult and has often found to bring patients to the point of exhaustion." Dr. Abraham Kocheril, professor of medicine and director of clinical electrophysiology at the University of Illinois-Chicago, where the Shape-HF System has already been installed, said, "The CRT response rate in heart failure patients is about 70%. The Shape-HF System is likely to help us get the remaining 30% – those we call non-responders – feeling better."

• SPO Medical (New York) said it has expanded its product offering for the hand-held SPO Medical PulseOx 6100 device with the introduction of a new pediatric sensor. The pediatric sensor is designed to further enhance applications of the product in the professional medical sector. In addition, the PulseOx 6100 now supports the Six Minute Walk Test (6MWT) which is widely used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease.

• Transoma Medical (St. Paul, Minnesota) reported FDA clearance for its new Data Review feature on Sleuth AT. The Data Review feature allows any clinician to easily access up to 99 events stored on the patient's Personal Diagnostic Manager (PDM). The PDM is a hand-held device that retrieves and stores ECG data from the implanted device prior to automatic transmission to the 24/7 monitoring center. Each stored ECG strip is labeled with the time and date of the cardiac event making it easier for clinicians to correlate symptoms with rhythms. The system includes a small implanted device that incorporates a sensitive arrhythmia. The Sleuth AT captures ECG strips containing arrhythmias automatically, and also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom. All data captured by the implanted device is automatically transferred to the PDM, providing an additional 10.5 hours of ECG storage. Data stored on the PDM is automatically transmitted to a 24/7 monitoring center where certified cardiac technicians review the data and alert clinicians to clinically-significant events.