Jun-08

GE Healthcare Nets FDA Clearance for High-Definition LightSpeed CT Scanner
The FDA has granted GE Healthcare 510(k) clearance for its LightSpeed CT750 HD, a high-definition CT scanner. The system debuted at RSNA 2007 in November 2007. The system includes a new scintillator design, crafted by changing the molecular structure of garnets. Using bright yellow garnets, GE engineers developed a scintillator capable of delivering images 100 times faster, with up to 33 percent greater detail through the body and up to 47 percent greater detail in the heart, the company said.
The LightSpeed CT750 HD’s Gemstone Spectral Imaging uses up to 2,496 views per rotation (a 2.5x increase) to deliver improved spatial resolution and improved image quality across the entire field of view, according to the company. GE said its dual energy kV switching registers energies at least 165 times faster than dual-source CT at a 0.33s rotating speed. The new CT also offers 128 slices of data per rotation and 101 user selectable energy levels for viewing.

Also, the scanner’s improved spatial resolution allows it to reduce calcium blooming artifacts, making accurate stenosis quantification possible. In bench testing, it was able to accurately measure 75 percent stenosis on a 3mm vessel within 100 microns. The scanner benefits from improved low contrast detection, according to GE. The company said the new scanner improves image quality while reducing dose by up to 50 percent across the entire body and by as much as 83 percent for cardiac scans. GE said the first clinical system will be installed soon at Froedtert Memorial Lutheran Hospital in Milwaukee, with shipments to clinical sites continuing this year.
GE said that commercial shipments are expected to begin “over the next several months.”

Many Patients With Heart Disease Have Poor Knowledge of Heart Attack Symptoms
Nearly half of patients with a history of heart disease have poor knowledge about the symptoms of a heart attack and do not perceive themselves to have an elevated cardiovascular risk, according to a report in the May 26 issue of Archives of Internal Medicine.
Individuals with heart disease have five to seven times the risk of having a heart attack or dying as the general population. Survival rates improve following heart attack if treatment begins within one hour. However, most patients are admitted to the hospital 2.5 to three hours after symptoms begin. “Barriers to seeking appropriate care quickly are both cognitive and emotional,” the authors write. If patients do not know the symptoms of acute myocardial infarction and other acute coronary syndromes — including nausea and pain in the jaw, chest or left arm — they will not seek treatment for them. If they do not perceive themselves to be at risk for heart attack, they will look for another explanation when they experience these symptoms.
Kathleen Dracup, DNSc, of the University of California, San Francisco, School of Nursing, and colleagues surveyed 3,522 patients (average age 67) who had a history of heart attack or angioplasty. The patients were asked to identify possible symptoms of heart attack and responded to true-false questions about heart disease. Participants also were asked whether they were more or less likely than other individuals their age to have a heart attack in the next five years.
The average cardiac knowledge score was 71 percent. Despite their history of heart disease, 44 percent of the patients had low knowledge levels, as documented by scores of less than 70 percent. Women, individuals who had participated in cardiac rehabilitation, those with higher education levels, younger individuals and those who received care from a cardiologist as opposed to a family practitioner or internist tended to score higher.
“In this group of patients, who were all at high risk for a future acute myocardial infarction, 43 percent inappropriately assessed their risk as less than or the same as other people their age,” the authors write. “More men than women perceived themselves as being at low risk (47 percent vs. 36 percent, respectively).”
Changes in the health care delivery system have led to less hospital time for heart disease patients, reducing the amount of time available for education about heart disease symptoms, the authors note. “Patients require continued reinforcement about the nature of cardiac symptoms, the benefits of early treatment and their risk status,” they write. “Our findings suggest that men, elderly individuals, those with low levels of education and those who have not attended a cardiac rehabilitation program are more likely to require special efforts during medical office visits to review symptoms of acute myocardial infarction and to learn the appropriate actions to take in the face of new symptoms of acute coronary syndromes.”
The researchers “found two modifiable factors identified with increased knowledge about coronary artery disease: participation in cardiac rehabilitation and receiving care by a cardiologist,” writes Robert A. Phillips, MD, PhD, of the UMass Memorial Medical Center, Worcester, in an accompanying editorial.
“These findings should help to fuel the recent focus on the barriers, benefits and methods to improve participation in cardiac rehabilitation by coronary artery disease patients,” he continues.
“Health care theory suggests that the highest level of care is provided when payments and best health care practices are aligned. To this end, payers such as Centers for Medicare and Medicaid Services and private insurers should develop a tiered approach to payment for cardiac care, providing higher reimbursements for those hospitals that offer cardiac rehabilitation and higher reimbursement to physicians and hospitals who consistently refer eligible patients for cardiac rehabilitation,” Dr. Phillips concludes.
(Source: Arch Intern Med 2008;168[10]:1049-1054;1029.)

Covidien Announces Acquisition of Specialty Injection Devices from Pinyons Medical Technology, Inc.

Handheld injectors expand contrast delivery systems portfolio Covidien, a global provider of healthcare products, announced it has signed an agreement with Pinyons Medical Technology Inc., a privately held company based in Park City, Utah, and its President and CEO, Shawn Fojtik, to acquire all assets related to the Pinyons POWRSyringe Injector and POWRSyringe Monitor handheld, manual injection and inflation devices. These devices facilitate manual x-ray contrast media injections during angiography procedures performed in the cardiac catheterization laboratory and interventional radiology suite.
Under the terms of the agreement, Covidien immediately obtains all assets related to these two Pinyons product lines, including all intellectual property, current and future product designs and regulatory filings and approvals. The injection and inflation devices have received clearance from the U.S. Food and Drug Administration.
Fojtik noted, “Our products are specifically designed to provide ergonomic and mechanical advantages over angiographic control syringes, especially during interventional procedures requiring repetitive, small-volume contrast media injections.”
The Medical Device Manufacturers Association awarded the Pinyons injector a 2008 Medical Design Excellence Award (MDEA) in recognition of design and engineering excellence in the medical technology community.

Volcano Announces Acquisition of Novelis, Inc.

Volcano Corporation, a provider of intravascular ultrasound (IVUS), functional measurement (FM) and Optical Coherence Tomography (OCT) products designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, has acquired Novelis, Inc., a privately-held company with proprietary ultrasonic visualization and therapy technology for minimally invasive diagnostic and therapeutic devices.
Volcano expects to add the Novelis products and capability onto its s5i multi-modality integrated platform/hub.
Novelis’ core product line is based on Forward-Looking Intravascular Ultrasound (FLIVUS) technology. The product line includes an image-guided crossing catheter that combines visualization, steerability and RF tissue ablation, designed to permit interventional cardiologists to safely cross chronic total occlusions (CTOs) in the coronary and peripheral arteries, and a forward-looking IVUS catheter (imaging-only version) to facilitate current guidewire-based CTO crossing techniques as well as other potential product offerings with possible applications outside of vascular medicine. This platform technology may have applications for numerous minimally invasive procedures including plaque modification in the coronary or peripheral arteries, guidance in structural heart procedures, including cardiac ablation guidance and therapy, breast biopsy guidance and therapy, and orthopedic (spine) guidance and therapy.
Scott Huennekens, president and chief executive officer of Volcano, noted, “It is estimated there are currently over 200,000 CTOs performed in the U.S., Europe and Japan each year. These procedures, which remain one of the most challenging issues faced by interventionalists today, often fail or take hours to successfully complete due to inadequate visualization. Furthermore, due to the lack of adequate tools for CTO crossing, many interventionalists simply refer patients with CTOs to highly invasive and costly coronary artery bypass grafting (CABG) procedures. The products under development by Novelis have the potential to shorten procedure times and minimize complications, plus dramatically add to the total number of procedures being performed – enabling patients with CTOs to be treated in the cath lab rather than in the surgery suite.” “At the estimated procedure volume of over 200,000 cases per year — and factoring in the potential for market expansion — the total market potential for Novelis’ CTO products is estimated at over $500 million,” he added.
“CTOs continue to be a challenge for even the very experienced interventionalist. Current angiographic tools are simply inadequate to guide CTO crossing,” commented Dr. Gary Mintz, Chief Medical Officer, Cardiovascular Research Foundation, Medical Director and Editor-in-Chief, TCTMD.com and advisor to Volcano. “The next step to improve success rates will come in the form of intravascular image-guided therapies such as this truly unique ‘forward looking’ approach to CTO imaging,” he added. “Many technologies have been tried; but to date, none have been particularly successful. Novelis is the first forward-looking technology that I have seen that makes sense and seems to have a strong likelihood of providing a viable solution for guiding CTO recanalization.”
“Catheter-based treatment of chronic coronary total occlusion is one of the remaining major clinical challenges in interventional cardiology,” commented Dr. David Williams, Professor of Medicine and Director of the Cardiac Catheterization Laboratory and Interventional Cardiology at Rhode Island Hospital and advisor to Novelis. “Currently, the lack of safe and predictable treatment modalities results in most CTO patients being referred to open-heart bypass surgery. I have performed pre-clinical work with the Novelis device which, in my view, demonstrated clear differentiation of coronary anatomy and sufficient ablative power necessary to guide the interventional cardiologist safely through a CTO.”
Novelis’ offering consists of a forward-looking manually steered imaging system comprised of a laptop-sized console with advanced custom software and single-use catheters both with and without RF ablation. The system and accessories are not approved for human use at this time and have not been submitted to FDA for regulatory clearance. The company expects to file for appropriate U.S. and international approvals on the first of several devices during 2009 and begin commercialization of a stand-alone imaging console in the second half of 2009 in the U.S. and Europe.

Boston Scientific Announces Launch of Expanded Size Range of Filterwire EZ^™ Embolic Protection System
New size allows for treatment of smaller-diameter diseased saphenous vein grafts Boston Scientific Corporation announced the launch of its FilterWire EZ^™ Embolic Protection System in a new 2.25 – 3.5 mm size, designed to contain and remove embolic material that may be dislodged during an interventional saphenous vein graft (SVG) procedure.
“Recently revised treatment guidelines by the American College of Cardiology have recommended the use of embolic protection devices when treating patients with SVG disease,¹” said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. “Until now, a filter-based solution smaller than 3.0 mm was not available for SVGs. By introducing this smaller size, Boston Scientific now makes it possible for physicians to meet this standard of care in a broader range of SVG vessels.”
The FilterWire EZ System is a low-profile embolic protection device that has been clinically proven to capture and remove embolic material, leading to reduced complications during balloon angioplasty and stenting procedures in SVGs.²
The complex nature and progression of SVG disease as compared to native coronary artery disease can create a challenging treatment situation for physicians and a higher risk for patients. In Boston Scientific’s BLAZE II study, which evaluated the safety and performance of the FilterWire EZ System’s 2.25 - 3.5 mm size, a 30-day major adverse cardiac event (MACE) rate of 4.6 percent was reported, with MACE defined as death, myocardial infarction, emergent CABG or revascularization. The study also resulted in no deaths, no target lesion revascularizations and no sub-acute thrombosis during the 30-day follow-up period. The BLAZE II study involved 131 patients in 16 sites in the United States.
“Despite the complexity of treating smaller vessel SVGs, this study presented excellent safety and efficacy data,” said Kucheman. “That should give physicians great confidence when treating the unpredictable SVGs they see in their practice every day.”

References
1. Smith SC Jr, et al., Circulation 2006; 113:156–175. 2. Stone GW, et.al., Circulation 2003;108:548–553.

WaveMark Solutions Streamline Healthcare Supply Chain and Improve Patient Safety
WaveMark, Inc., provider of real-time inventory management solutions for high value specialty products within the healthcare supply chain, announced its supplier solutions, complementing its hospital offering, in an effort to streamline the complex healthcare supply chain. WaveMark provides inventory management solutions that enable both medical device suppliers and hospitals greater visibility and control over inventory and product use.
WaveMark’s proven expertise in RFID allows suppliers to focus on eliminating inefficiencies in the healthcare supply chain and hospitals to focus on reducing inventory levels, ensuring a better product mix to support physician preferences. This unique approach ultimately provides both hospitals and suppliers with stronger visibility into inventory and usage that not only results in better management of on-hand inventory and expirations, but significantly increases patient safety and reduces the costs of healthcare to the public.
“Use of our inventory management solutions by hospitals and medical device suppliers provides strong benefits to both parties as they look to streamline the supply chain,” said John Wass, CEO, WaveMark. “WaveMark solutions provide real-time information to better manage and control the inventory of high value, physician preference products, which in turn eliminates waste and improves patient safety.”
WaveMark Real-Time^™ and WaveMark Mobile^™. RFID-enabled inventory solutions, WaveMark Real-Time and WaveMark Mobile, are designed specifically for the unique field inventory and production planning needs of the device supplier.
WaveMark Real-Time captures product level information from WaveMark CIMS cabinets. This real-time data allows suppliers to improve service to each individual hospital by managing product expirations, recommending par levels, eliminating stock outs, and providing a better understanding of trends in product use. As a more efficient way to capture information, RFID offers a responsive service to the hospitals and is available at a lower cost to suppliers.
WaveMark Mobile provides suppliers with field inventory visibility, and simultaneously delivers sales force workflow efficiencies by automating common sales transactions. Suppliers can provide better customer service by enabling product visibility for the sales force to manage product expirations resulting in timely replenishments for hospital customers. In addition, WaveMark’s RFID technology provides the inventory accuracy needed by suppliers to help meet regulatory requirements. WaveMark CIMS Eliminates Manual Inventory. WaveMark’s original solution, WaveMark CIMS, has been in use in clinical labs since 2005. WaveMark CIMS leverages RFID and networking technologies to track and manage medical device inventory delivering rapid ROI by eliminating manual processes and providing a highly efficient workflow.
WaveMark’s use of RFID offers a highly accurate inventory of medical devices and provides detailed tracking information for hospitals. Hospitals are able to reduce inventory levels, better manage expirations, and ensure the right product is available when needed, helping to meet Joint Commission regulations. WaveMark’s subscription service model makes inventory and usage information accessible to hospitals of any size without the constraint of a capital approval process.
For more information, please visit www.wavemark.net

Abbott Launches Next-Generation

StarClose^® SE Vascular Closure System Abbott announced the launch of the StarClose^® SE Vascular Closure System, a next-generation vessel closure device engineered to enable fast, safe and secure closure of the femoral artery access site following a catheterization procedure. StarClose SE is available in the United States and Europe. StarClose SE, which stands for “Safe and Extravascular,” builds upon the design of its predecessor, StarClose, with more ergonomically-friendly design features. StarClose SE advancements include:
• Improved ease of use, with an intuitive, numbered system, providing visual guidance and audible “clicks” for each step leading to clip deployment
• Immediate vessel closure with deployment of a shape-memory clip onto the surface of an artery, allowing patients to recover and be discharged sooner than with manual compression.
• Added device stability for the operator during clip deployment
“With a more ergonomic stabilizer and simpler, numbered-step deployment, StarClose SE offers users the ability to close an artery in a fast, safe and effective manner following a catheterization procedure,” said David Lee, MD, assistant professor of Medicine and director of Cardiac Catheterization and Coronary Intervention Laboratories at the Stanford School of Medicine. “With its definitive mechanical closure, StarClose SE enables an operator to confirm a reliable closure immediately, which offers important benefits for physicians and patients in reducing patient time to mobility following these procedures.”
StarClose SE utilizes the same nitinol (nickel and titanium) clip technology as StarClose to close the femoral artery access site after a catheterization procedure. When deployed, the small nitinol clip grasps the tissue on top of the artery around the access site in a purse-string fashion and closes the opening in the femoral artery rapidly and securely with minimal affect to the lumen diameter or the blood flow inside the vessel.
For important safety information about StarClose SE, as well as additional information about this product, please refer to www.abbottvascular.com.

St. Jude Medical Announces FDA Clearance and CE Mark Approval of Strada Carotid Guiding Sheath

St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Strada^™ Carotid Guiding Sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries. The Strada Carotid Guiding Sheath is designed specifically to provide easier and faster access to challenging carotid anatomy.
“The Strada Carotid Guiding Sheath is a versatile sheath that is particularly adaptable to the tortuous carotid anatomy,” said Theodore Schreiber, MD, specialist-in-chief, vice president of Cardiovascular Development and division chief of Clinical Cardiology, Detroit Medical Center.
The Strada Carotid Guiding Sheath is engineered with five distinct transition zones to provide flexibility on the far, or distal, end of the sheath, and support on the near, or proximal, end of the sheath. Its construction provides excellent kink resistance for added confidence in navigating challenging anatomy. The Strada Carotid Guiding Sheath is available in 80 and 90 cm working lengths.

Performance Measurement, Tracer Methodology the Focus of JCR Published Books
Joint Commission Resources (JCR) offers two new books, Tools for Performance Measurement in Health Care: A Quick Reference Guide, Second Edition and Tracer Methodology: Tips and Strategies for Continuous Systems Improvement, Second Edition. JCR is a not-for-profit affiliate of The Joint Commission.
Tools for Performance Measurement in Health Care: A Quick Reference Guide, Second Edition provides a wide range of data collection tools and explanations on use — from basic to complex — and tells organizations how, when, and why to use the tools. This book includes strategies, tips, and forms that can be used or adapted for collecting and evaluating data in various health care settings and patient care populations. In addition, the book and accompanying CD-ROM offers step-by-step instructions on how to implement tools for systems analysis and includes practical, printable forms to help health care organizations use performance measurement tools for many processes. Tools for Performance Measurement in Health Care: A Quick Reference Guide, Second Edition is available for $99 using order code TPMHC200.
Tracer Methodology: Tips and Strategies for Continuous Systems Improvement, Second Edition provides health care organizations with new, practical tracer examples and hands-on tools for understanding and conducting tracers in any health care setting. Since tracer methodology remains an integral part of The Joint Commission’s on-site survey process, this extensively updated edition offers a new comprehensive overview of the tracer methodology. New examples of tracers are written from a surveyor’s perspective to show you how to conduct your own. A new chapter explains program-specific tracers and includes sample tracer questions. Domestic and international organizations also share how they have used tracer methodology and data to make improvements at their facilities.
A companion CD-ROM contains worksheets that can be customized by any size health care organization and video clips showing how to conduct tracer interviews with staff members and patients. Tracer Methodology: Tips and Strategies for Continuous Systems Improvement, Second Edition with CD-ROM is available for $99.00 using order code JTM08.
To order publications, call JCR Customer Service toll-free at 877.223.6866, 8 a.m. to 8 p.m. eastern time, weekdays, or visit www.jcrinc.com.
Joint Commission Resources, Inc. (JCR), a not-for-profit affiliate of The Joint Commission, has been designated by The Joint Commission to publish publications and multimedia products. JCR reproduces and distributes these materials under license from The Joint Commission. JCR educational programs and publications support the accreditation activities of The Joint Commission, but are separate functions. Attendees at JCR educational programs and purchasers of JCR publications receive no special consideration or treatment in, or confidential information about, the accreditation process.

Expanded Color Options and Accessories Enhance Harmony Small Cart Offering

InnerSpace has added six (6) pre-configured carts to the Harmony line-up, including larger versions of their Crash, Anesthesia and Isolation carts, a Pediatric Emergency cart, a Suture cart and a Line cart. The popular “Build A Cart” option now includes eight colors of drawer fronts (white, red, blue, yellow, green, lavender, light blue and teal).
The “Build-A-Cart” option allows for custom configurations using 3”, 6” and 9” drawers or 3”, 6” and 9” trays and baskets. A locking drawer can be used in conjunction with trays and baskets to comply with Joint Commission standards for medications and syringes.
New accessories include a tape dispenser (counter top and rail mount), suture shelf, work surface cover and side storage bins. Two new 3” tray divider sets are now available and an individual drawer lock can be added to any drawer.
Harmony carts now come equipped with 5” full-swivel plate casters, making the cart easier to roll and maneuver on carpeted floors and across elevator thresholds. A directional tracking caster is also standard equipment, keeping the cart rolling straight when being pushed over long distances.
InnerSpace Corporation brand names include; Datel^®, Harmony^®, spaceTRAX^® and Q line.
For more information, visit the company’s website at www.innerspacecorp.com.

Vascular Solutions Launches Ultra-Low Profile MICRO Elite™ Snare

Vascular Solutions, Inc. announced its partnership with Radius Medical Technologies, Inc. and the U.S. launch of the MICRO Elite Snare, a unique device designed for the retrieval and manipulation of foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
The MICRO Elite Snare is the only available snare that can be deployed through a 0.014” lumen, making it deliverable through conventional micro-catheters and balloon catheters. Even with its ultra-low profile, the MICRO Elite Snare features a robust cobalt chromium helical loop design for optimal retrieval and manipulation. The loop is encapsulated in a platinum coil to enhance visualization under fluoroscopy. The cobalt chromium loop is highly flexible and torqueable for atraumatic delivery. Developed and manufactured by Radius Medical Technologies, Acton, Mass., the MICRO Elite Snare comes pre-assembled and is currently available in the United States exclusively through Vascular Solutions.
For more information, visit www.vascularsolutions.com.
MICRO Elite^™ is a trademark of Radius Medical Technologies, Inc.

Sodium Nitrite Reverses Ischemia in Study
An experimental therapy to restore blood flow to tissues damaged by vascular disease can rapidly improve circulation by stimulating the growth of new blood vessels, according to a recently released animal study.
In experiments on mice, researchers showed that daily shots of sodium nitrite generated new blood vessels and restored blood flow in ischemic tissues, in just three to seven days — a fraction of the time it would ordinarily take.
“This is one of the most effective agents for inducing new blood vessel growth that we have seen to date in our research,” said Christopher Kevil, an associate professor of pathology at Louisiana State University Health Sciences Center in Shreveport.
Previous research has shown that nitric oxide (NO) or nitric oxide “donor” therapy can stimulate new blood vessels, returning blood flow to normal, but when the compound is administered in certain forms, it can cause a drop in blood pressure and other side effects.
For this experiment, the investigators decided to test a novel NO donor — sodium nitrite — in a mouse model of ischemia. Sodium nitrite is a cheap and readily available compound that is often used as a food preservative, but more importantly is metabolized to NO in the body, but only in ischemic tissues.
The investigators induced ishcemia in the hind legs of mice by tying off the animals’ femoral arteries to cut off the blood flow to the limb. They then injected them with low-dose sodium nitrite twice a day.
By the third day of therapy, the animals’ hind legs were showing signs of new blood vessel growth or angiogenesis. By the seventh day of therapy, the blood supply was almost back to normal. In contrast, in a control group of mice that were not given any treatment for ischemia in their hind legs, it took 28 days for circulation to return to normal.
“The treatment has tremendous potential for stimulating angiogenesis to alleviate the discomfort caused by ischemia, and at the dosages we used, sodium nitrite is safe and far below any toxicity threshold,” said Kevil.
“Moreover, our work also suggests that sodium nitrite therapy could be beneficial for stimulating angiogenesis and tissue healing after ischemic events seen in stroke and heart attacks.” The paper appears in the Proceedings of the National Academy of Sciences.

XTENT Announces Positive Six-Month CUSTOM III Trial Data
XTENT, Inc. announced positive six-month follow-up data from the CUSTOM III clinical trial, which assessed the safety and efficacy of the Custom NX^® drug-eluting stent (DES) system for the treatment of patients with coronary artery disease. Custom NX is designed to enable a more personalized approach to the treatment of arterial disease based on each patient’s individual lesion characteristics. Physicians can customize the length and diameter of the stent at the site of the lesion. The system features a proprietary modular stent design that consists of multiple 6 mm cobalt chromium segments coated with Biolimus A9 and PLA, a biodegradable drug carrier.
The Custom NX delivery system enables separation at each 6 mm segment and allows for the placement of up to 60 mm of stent. The CUSTOM III clinical trial was a 90-patient prospective study to assess the safety and efficacy of the Custom NX drug-eluting stent system in patients with up to two de novo lesions treatable with up to 60 mm of customizable stent length. The primary endpoint was major adverse cardiac events (MACE) at 30 days, with secondary endpoints of MACE at six months, binary restenosis, late loss, and stent thrombosis.
CUSTOM III enrolled a challenging patient population, with 67% of the lesions classified as complex B2/C, an average lesion length of 19.8 mm, and an average reference vessel diameter (RVD) of 2.6 mm. The CUSTOM III trial included some of the longest lesion lengths and smallest RVDs compared to previous drug-eluting stent trials.
For the primary endpoint, MACE at 30 days, the rate was 2.2%, consisting of two in-hospital non Q-wave myocardial infarctions (MIs). At six-month follow-up the MACE rate for CUSTOM III was 7.8%. There were zero deaths, zero Q-wave MIs, two non Q-wave MIs, or 2.2%, and five clinically-driven target lesion revascularizations, or 5.6%.
There was one case of early stent thrombosis in the trial and zero late stent thrombosis. The in-stent late loss for CUSTOM III at six-month follow up was 0.17 mm, the in-stent binary restenosis rate was 4.4%, and the neointimal hyperplasia (NIH) volume was 3.8%. “The CUSTOM III results are very promising and demonstrate the safety of in situ customization for treatment of simple and complex lesions. The IVUS and angiographic results confirm the efficacy of the Custom NX stent, and the Biolimus A9^® and PLA formulation,” said Bernard De Bruyne, MD, PhD, of the OLV Clinic in Aalst, Belgium, and Principal Investigator for the CUSTOM III clinical trial.
The Custom NX DES System has not been approved for sale by any regulatory authority.

 

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