Just 60 days after submitting its application, Spectranetics (Colorado Springs, Colorado) last month received FDA clearance for its Turbo-Booster product treatment of arterial stenoses and occlusions in the leg, a broader indication for use as compared to current labeling of the existing peripheral laser catheters, the company said.
The Turbo-Booster functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. The Turbo-Booster combined with Turbo elite laser catheters allows for removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries, Spectranetics said.
The company submitted its 510(k) application in May. That news came just two months after the company reported halting its CELLO trial after completing about three quarters of enrollment, with the FDA’s approval. The trial was stopped, the company said, because its preliminary data was strong enough to meet the endpoints.
“I think we’ve had a good relationship with the FDA,” Will McGuire, COO of Spectranetics told Cardiovascular Device Update. “I think we had a good and open dialogue with the FDA from the beginning. We were very clear about what we wanted to do and they were very clear about what we needed to do.”
McGuire called the Turbo-Booster a “market-expanding product” for Spectranetics, because it will help the company enter the above-the-knee market. “The important thing for us is right now two-thirds of our catheters are used below-the-knee and the Turbo-Booster allows us to make larger channels, or larger holes, [in above-the-knee procedures,” McGuire said.
CELLO, conducted to provide data to FDA in support of the clearance for the Turbo-Booster, is a prospective registry that enrolled 61 patients at 16 centers in the U.S. The trial included patients with stenoses and occlusions that were greater than or equal to 70% and less than or equal to 100% of the vessel lumen within arteries four to seven millimeters in diameter.
Three independent cre labs analyzed the angiographic, intravascular ultrasound, and duplex ultrasound data from the trial. The primary endpoints of the trial were the achievement of a minimum 20% reduction in the percent diameter stenosis post-laser compared to pre-intervention and major adverse events. The reduction in percent diameter stenosis following the use of the Turbo-Booster was 35% and there were no major adverse events reported through 30 days following the procedure. As a result, the primary endpoints were met.
“We are very pleased with the clinical data from the CELLO trial, and the subsequent positive response from the FDA, which places our Turbo-Booster program well ahead of the original timeline.Turbo-Booster significantly expands our addressable market, as we believe approximately two-thirds of all endovascular procedures in the legs are in the larger diameter arteries above the knee,” said John Schulte, Spectranetics’ president/CEO.
He said the company’s would begin a controlled release of the product over the next 30 days, allowing for collection of feedback to guide training and marketing. “We expect to complete the initial launch to our atherectomy account base of approximately 350 accounts within a period of four to five months. After completion of the initial phase of the launch and receiving clinical and marketing feedback regarding the performance of the Turbo-Booster, we will update our annual financial guidance, which we expect to occur during our investor conference call discussing third quarter financial results in late October.”
McGuire said the company would initiate two clinical trials in the second half of 2007, one in the U.S. and one in Germany, to assess the effectiveness of the Turbo-Booster and existing peripheral atherectomy products for the treatment of in-stent restenosis.
Founded in 1984, Spectranetics says it makes the only excimer laser approved in the U.S., Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The company’s disposable catheters use high-energy “cool” ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads.
Elsewhere in the product pipeline
• Affymetrix (Santa Clara, California) reported that researchers from the Wellcome Trust Case Control Consortium (WTCCC) and the Cardiogenics Consortium used its GeneChip microarray technology to discover several genetic variations that may increase the risk of developing coronary artery disease (CAD) by as much as 36%. The results of the project were published in the July 18 issue of the New England Journal of Medicine. Traditionally, scientists performing genetic association studies have had to focus on a specific subset of genes to replicate findings from initial genome scans. WTCCC and Cardiogenics researchers used the same genome-wide Affymetrix GeneChip 500K Arrays to replicate two genetic associations from their two separate internal cohort samples, and to identify four new variations. The Wellcome Trust is an independent charity funding research to improve human and animal health. Affymetrix makes products that provide researchers with a more complete view of the genome.
• Boston Scientific (Natick, Massachusetts) reported the beginning of clinical trial enrollment in studies evaluating its third-generation paclitaxel-eluting coronary stent, the Taxus Element stent. The Taxus PERSEUS clinical program will collectively enroll about 1,500 patients at 100 U.S. and international centers. The Element stent features a platinum chromium alloy designed specifically for stents. This alloy, coupled with a new stent design, is designed to enable thinner struts, increased flexibility, and a lower profile while improving radial strength, recoil, and radiopacity. In addition, the stent platform incorporates new balloon technology, intended to improve upon the company’s Maverick balloon catheter technology. Dean Kereiakes, MD, principal investigator of the study, said, “This new platform, designed for improved deliverability, should allow us to bring the long-term proven performance of the Taxus stent to even the most complex and challenging anatomy.”
• CoAxia (Minneapolis) said that investigation of its NeuroFlo perfusion augmentation technology has been extended to patients who do not respond to thrombolysis with the drug tissue plasminogen activator (tPA), the only stroke therapy currently approved by the FDA. Already being evaluated as a stand-alone treatment for patients that are outside the three hour tPA treatment window, NeuroFlo cerebral perfusion augmentation was successfully performed for the first time on a patient who had previously received tPA by the stroke team at University of Alberta Hospital in Edmonton, Alberta. The NeuroFlo treatment is intended to deliver increased blood flow to the affected, but still salvageable, area of the brain in stroke patients by increasing flow via collateral pathways “around” a blocked artery. The therapy is accomplished with a unique, dual-balloon catheter that creates a partial occlusion of the descending aorta and redirects blood flow to the brain. CoAxia is a venture-backed, privately held, development-stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions.
• The first U.S. patients in the pivotal Phase II trial of the Zilver PTX stent, made by Cook Medical (Bloomington, Indiana), were treated in July at Tri-City Medical Center (Oceanside, California), the company reported Monday. The patients were treated by principal investigator Richard Saxon, MD, assistant clinical professor of radiology at the University of California, San Diego, as part of the international Zilver PTX Stent Trial. “Drug-eluting stents that combine a metal scaffold with a drug were first applied in the heart, and the results have been very good,” Saxon said. “And it is hoped similar technology, used in the legs, will help those who suffer from peripheral arterial disease [PAD}.” The trial is intended to evaluate the stent, eluting the drug paclitaxel, in treating PAD, a condition that affects more than 10 million Americans each year, Cook said. The study aims to determine if the same type of DES technology found in DES devices used to open blockages in the coronary arteries can be used to treat blockages in arteries outside the heart. Following successful safety testing during the trial’s Phase I enrollment, Cook will enroll more than 700 patients in the Phase II trial that will be used to support submission to the FDA. Rob Lyles, VP and global leader of Cook’s peripheral intervention division, said that the Zilver PTX trial is the only ongoing trial for PAD with a stent/drug combination. There were some earlier trials in this area initiated by competing companies, he said, but so far there are no FDA approved DES devices on the market for the PAD application. The trial is being conducted at 28 U.S. locations and is the first device trial ever conducted simultaneously in the U.S. and Japan, Lyles said. Clinical data collected on Japanese and U.S. patients will be combined for the final evaluation of the device and used for regulatory submissions in both markets for approval. The trial will enroll patients who will be randomized to receive either the Zilver PTX stent or balloon angioplasty.
• CryoCath Technologies (Montreal) in July presented data for its Arctic Front catheter system to treat Atrial Fibrillation (AF) at the European Society of Cardiology (Europace) Conference in Lisbon, Portugal. The data included the original 19 proof of concept patients treated with the 21 mm non-steerable balloon/ sheath as well as the early feasibility data. It also includes patients with all types of AFib treated including paroxysmal, persistent and chronic. In the cohort of true paroxysmal AF patients, 84% were free of AF after only one procedure. When additional patients with hypertension and persistent AF were analyzed, 63% were free of AF after one procedure. For patients with recurrence, chronic success rates rose to nearly 80% after a second procedure was performed. Additionally, data on another 100 patients produced similar results. In the data presented, no Arctic Front catheter related serious adverse events.
• diaDexus (South San Francisco) reported the results of a new study indicating that Lp-PLA (2), a specific indicator of vascular inflammation, provides information over and above traditional risk factors — such as smoking and high blood pressure — to help identify individuals at the highest risk for ischemic stroke. the PLAC test measures lipoprotein-associated phospholipase A (2) (Lp-PLA (2)). The test was cleared for marketing in coronary heart disease in 2003 and was the biotech company’s first FDA-approved product. Results of the study were presented at the 18th annual scientific sessions of the Society for Vascular Medicine and Biology (Northbrook, Illinois) in Baltimore. Christie Ballantyne, MD, of Baylor College of Medicine (Houston), led the prospective case cohort study of 12,762 apparently healthy middle-aged men and women in the Atherosclerosis Risk in Communities (ARIC) study. The researchers evaluated patients using traditional risk factors for stroke, such as age, sex, race, smoking, blood pressure, cholesterol levels, diabetes and body mass index. They then categorized the risk levels of those patients as low, moderate and high. Then the researchers measured levels of the inflammatory indicators Lp-PLA(2) and C-reactive protein (CRP) to determine if the biomarkers helped further classify patients’ five-year risk for stroke. diaDexus said the results showed that the addition of Lp-PLA(2), as measured by the company’s PLAC test, and CRP significantly improved stroke risk assessment by reclassifying 37% of the moderate-risk category, as opposed to relying on traditional risk factors alone to make an estimation. The PLAC test has been cleared for marketing by the FDA as an aid in predicting risk for coronary heart disease and ischemic stroke associated with atherosclerosis.
• Ivivi Technologies (Northvale, New Jersey) reported that it has completed enrollment in its clinical trial using the company’s pulsed electromagnetic field (PEMF) technology to treat patients with ischemic cardiomyopathies. The trial at the Cleveland Clinic is designed for cardiac patients who are not candidates for surgical intervention such as angioplasty, stenting or cardiac bypass surgery. The trial looks at the use of Ivivi’s PEMF technology over a period of five months on patients with ischemic cardiomyopathy, a heart condition characterized by decreased blood flow to the heart. The primary endpoint is the improvement in regional myocardial perfusion (the flow of blood through the heart) and function as seen with a 64-slice computed tomography (CT) Scan. The secondary endpoint is patient improvement for angina and exercise tolerance. Ivivi Technologies specializes in non-invasive electrotherapeutic technology.
• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance and a Health Canada License for its ACross Transseptal Access System, a device that improves control and simplifies the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation ablation. The device is used to reach the left atrium of the heart, which is difficult to access but where some of the most complex arrhythmias (irregular heartbeats) occur. The ACross Transseptal Access System consolidates the sheath, dilator and needle into a single interlocking handle for greater control over the system’s components and more intuitive positioning within the heart. The device’s handle allows the components to fit precisely together, ensuring that the puncture needle is not deployed until the physician is confident in its location, and that it is only advanced a pre-determined distance. Also, the ergonomic design incorporates a directional fin, or ridge, on the handle, so that the physician will intuitively know the orientation of the needle and sheath tip within the heart.
St. Jude also reported the first patient implant in its clinical trial of Trifecta, a new investigational stented, pericardial tissue heart valve. The patient was the first of about 500 adult enrollees. The trial will evaluate the safety and efficacy of Trifecta as a replacement for the aortic valve.