Advanced Tissue Sciences (ATS; La Jolla, California) in early March presented data providing what it termed "the first demonstration of tissue engineering's ability to stimulate blood vessel formation in the heart." The data were presented at the 7th biennial meeting of the International Society for Applied Cardiovascular Biology in Tucson, Arizona.

Conducted in conjunction with researchers at the University of Arizona (Tucson), the studies demonstrated the ability of ATS's Dermagraft metabolically active, tissue-engineered epicardial patch to induce blood vessel formation and improve cardiac function. New blood vessels formed as early as 14 days after product application and then continued maturation.

A human-based, tissue-engineered product, the epicardial patch secretes a variety of growth factors and matrix proteins, including at least three factors that are key to blood vessel formation and maintenance: Vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF) and angiopoietin-1.

"The angiogenic effects induced by Dermagraft in these studies exceed the results achieved in previous studies reported to date using either a single growth factor or gene therapy," said Stuart Williams, PhD, professor and chairman of the department of biomedical engineering at the University of Arizona. "Dermagraft has the ability to secrete angiogenic factors continuously and directly onto the damaged heart. In clinical applications, this has the potential to reduce chest pain and improve heart function."

Elsewhere in the product pipeline:

AVI BioPharma (Portland, Oregon) said it successfully completed a Phase I trial on Resten-NG, its Neugene antisense drug designed to prevent cardiovascular restenosis. The company plans to advance the drug into a Phase II trial. Researchers did not identify any drug-related safety issues.

Boston Scientific (Natick, Massachusetts) has received approval from Germany's Freiburg Ethics Commission International to conduct a clinical trial of paclitaxel-coated coronary stents, as well as progress in other areas of stent development. The dose-escalating study will be launched in the second quarter of this year to evaluate the safety and feasibility of coronary stents coated with paclitaxel, a chemotherapeutic agent, to reduce restenosis.

C.R. Bard (Murray Hill, New Jersey) said that its subsidiary, Davol, has received FDA approval to market Avitene Ultrafoam collagen hemostat, a collagen sponge used to stop bleeding during surgical procedures. The Ultrafoam product accelerates blood clot formation, and the company calls it "the only collagen hemostatic sponge approved for use in all surgical applications, including neurosurgery, the surgical specialty using topical hemostats most frequently." The Ultrafoam does not require the traditional addition of thrombin, a liquid clotting agent to control bleeding, but rather is made from Avitene collagen, a natural clotting agent. The sponge features the ability to conform to various and irregular anatomical structures and is available in five different sizes.

Cardiac Pathways (Sunnyvale, California) said in mid-March that it has received 510(k) clearance from the FDA to begin marketing the Real-time Position Management (RPM) Tracking System. The proprietary technology can be used in most diagnostic electrophysiology procedures for real-time visualization of catheters and is expected to assist physicians in precisely manipulating catheters within the heart during procedures, offering the potential for reductions in procedure times. RPM catheters contain ultrasound transducers that are used to precisely triangulate, in real-time, the position of the catheters during a diagnostic procedure. The supporting RPM Tracking System computer combines the ultrasonic signals with 3-D graphics to display real-time catheter positions and track catheter movement, while recording the associated intercardiac electrical signals. Thomas Prescott, president and CEO of Cardiac Pathways, said rollout of initial systems to early users can now begin within the next 60 days.

COR Therapeutics (South San Francisco, California) said Integrilin injection reduced the combined incidence of death, heart attack, need for urgent repeat intervention, or the need for thrombotic bail-out therapy from 10.5% with placebo to 6.6% over the 48 hours following non-urgent balloon angioplasty combined with intracoronary stenting. Integrilin also reduced the combined occurrence of death and heart attack at 48 hours from 9.2% to 5.5%, a statistically significant reduction.

CV Therapeutics (Palo Alto, California) presented results of its Phase III trial of ranolazine, a drug candidate for the potential treatment of chronic angina, at the 49th annual meeting of the American College of Cardiology in Anaheim, California. Results indicated that at each of the three doses studied, ranolazine was associated with statistically significant increases in patients' treadmill exercise duration with no clinically meaningful effects on blood pressure or heart rate compared to placebo. CV Therapeutics also said Phase I results of CVT-510 indicate the compound may be a potential therapeutic option for immediate and sustained control of rapid heart rate with minimal effects on blood pressure or normal heart rates. The data show that CVT-510 may slow the heart rate by selectively targeting the adenosine A1 receptor. The company plans to confirm the findings in a Phase II trial in patients with atrial arrhythmias.

Electrograph Systems (Hauppauge, New York) a wholly owned subsidiary of Manchester Equipment and a distributor of plasma display monitors in the U.S., has introduced what it calls "the world's first fully integrated direct digital plasma display," the Electrograph Direct Digital Model E4203DD. The company uses technology developed and licensed from the British Broadcasting Company and Electrograph has the exclusive rights to the technology in the U.S.

Emisphere Technologies (Tarrytown, New York) is initiating a Phase I safety and tolerability study in healthy subjects of a solid oral dosage form of heparin. The trial will take place in the UK. The liquid dosage form of heparin is in Phase III development. Heparin is used for preventing and treating deep vein thrombosis and other cardiovascular conditions.

EndiCOR Medical (San Clemente, California) has launched Phase II of the X-TRACT Clinical Trial of its X-SIZER Catheter System, a disposable device designed to remove blood clots and other blockages from coronary arteries and bypass grafts. The catheter system combines a vacuum with a rotating Archimedes-type cutter housed within the tip of a catheter. During operation, the X-SIZER pulls blood clots and loose tissue into the catheter tip and removes the debris from the vessel. It comes as a pre-assembled, sterilized, and disposable system, and is covered by two U.S. patents, with additional patents pending.

EndoSonics (Rancho Cordova, California), a developer of advanced intravascular ultrasound (IVUS) and functional assessment products, introduced two new Visions digital catheters at the American College of Cardiology meeting. The catheters address the markets for abdominal aortic aneurysm stent grafts and additional peripheral treatment. The Visions Peripheral Vascular 8.2 Fr and Peripheral Vascular 0.018" catheters are FDA-approved, feature new integrated circuit technology for improved image quality, and provide imaging capabilities to greater depths. The company also introduced the Avanar IVUS catheter, which builds on its all-digital Visions Five-64 product line with improved integrated circuit technology and image quality. The Avanar also has a lower profile than previous catheters, allowing easier travel through tight tissue structures, small tortuous vessels, and stents. It is compatible with the smallest stent-balloon systems in use today. EndoSonics recently filed an FDA application for this catheter and anticipates approval in 2Q00. It also anticipates receiving the CE Mark for marketing the Avanar catheter in certain European countries in the same quarter.

Guidant (Indianapolis, Indiana) has received FDA approval to market the Discovery II single-sensor pacemaker in the U.S. "The Discovery II device's expanded diagnostic capability will complement our very successful blended sensor product, the Pulsar MAX pacemaker," said Fred McCoy, president of Guidant's Cardiac Rhythm Management Group. The Discovery is designed to enable a physician to perform a set of automatic test and follow-up operations and to provide a single report that concisely presents information need for informed patient management. Guidant said it will begin shipments early this month.

Heartport (Redwood City, California) said it has received the CE Mark for its Precision OP beating-heart bypass system. Heartport began full-scale commercial introduction of the Precision OP system in the U.S. in 4Q99. The Precision OP system, which facilitates open-chest, off-pump, beating heart, multi-vessel CABG, features the disposable Still Site Stabilizer, a device designed for stabilization of the target coronary arteries and the reusable OPTrac Retractor, used in other open-chest procedures. The OPTrac has interchangeable, reusable retraction blades designed for varied patient anatomy and surgical approaches. The company said that cardiac surgeons using the PrecisionOP system find it "more stable, giving them optimal access to and stabilization of targeted vessels at all locations, particularly those on the back wall of the heart. Because these vessels are often the hardest to reach and control, this system's attributes make it ideal for more complicated multi-vessel CABG operations."

Interleukin Genetics (San Antonio, Texas) said data demonstrated that individuals with specific variations in the interleukin-1 genes have an 81 percent increased risk of requiring retreatment after angioplasty procedures. The data were compiled from 1,850 patients who underwent coronary stent placement to reopen blocked coronary arteries.

IntraLuminal Therapeutics (Carlsbad, California) announced at the American College of Cardiology meeting the European launch of the Safe-Steer Guidewire and Catheter Crossing System. Abstracts also were presented at the meeting reporting on the safety and utility of the system. The company is developing a line of products specifically for crossing and recanalizing total occlusions, using a forward-looking guidance and control technology. IntraLuminal's first crossing system is specifically designed for total arterial obstructions. The company said its platform technology has broad therapeutic application for a variety of cardiovascular, surgical, neurological, carotid and men's/women's health procedures. IntraLuminal also said it has received notification from the U.S. Patent and Trademark Office allowing claims for "Systems and Methods for Guiding a Medical Instrument Through a Body." These claims further expand protection of the company's core technology which uses optical coherence reflectometry technology as a navigational tool for medical devices. To date, seven patents have been granted in the U.S., and an additional nine patents have been filed both domestically and internationally.

IntraTherapeutics (St. Paul, Minnesota) has received FDA 510(k) clearance to market its IntraStent DoubleStrut LD biliary endoprosthesis, a balloon-expandable, stainless-steel stent that features flexibility, placement accuracy, and a diameter expansion range that allows optimal performance in large lumen procedures. It is available in 16 mm, 26 mm, 36 mm, 56 mm, and 76 mm lengths, with an expansion range of 9 mm to 12 mm. The IntraStent DoubleStrut LD joins the IntraStent, IntraStent, DoubleStrut, and IntraCoil range of stent products.

Pharmacyclics (Sunnyvale, California) started a Phase I trial of photoangioplasty with Antrin (motexafin lutetium) Injection to treat coronary artery disease. In the study, Antrin is administered intravenously 18 to 24 hours before patients receive standard balloon angioplasty.

United Therapeutics (Silver Spring, Maryland) and the Rush Heart Institute Center for Pulmonary Heart Disease at the Rush-Presbyterian-St. Luke's Medical Center (Chicago, Illinois) began patient enrollment in a Phase III trial of the tablet beraprost for the treatment of moderate pulmonary hypertension. Betaprost is an oral form of prostacyclin, a molecule that is produced in the body's blood vessels to keep them dilated and free of platelet aggregation.

Radiance Medical Systems (Irvine, California) has received four new U.S. patents covering methods and designs surrounding catheter products. Two of these patents cover new designs and claims revolving around the company's Focus Technology balloon angioplasty and coronary stent delivery catheters. Radiance markets a number of PTCA and stent delivery catheters throughout the world and also has licensed selected applications of its Focus Technology to Guidant for use in the delivery of that company's stent products.

St. Jude Medical (St. Paul, Minnesota) has announced results of an initial clinical study in Germany of the Aortic Connector System, part of a system of suture-free devices facilitating coronary artery bypass graft (CABG) anastomosis. The system was developed by the St. Jude Medical Cardiovascular Group, formerly Vascular Science, acquired by St. Jude last September. The initial clinical study took place at the Siegburg Heart Center (Siegburg, Germany), under the direction of Stein Iversen, MD, PhD, chief of the department of cardiovascular surgery. In a 23-patient trial, the system deployed as designed, providing instantaneous anastomosis at the proximal site. St. Jude said it will expand the clinical evaluation of the Aortic Connector System in the near future and said it also is conducting preclinical analysis of a product for distal anastomosis. The system is currently under FDA 510(k) review, and St. Jude has submitted an application for CE Mark approval. The company said it anticipates regulatory approval and market launch in 2Q00. St. Jude also has received FDA marketing approval for its 6 Fr Angio-Seal puncture closure device, designed to reduce the time and effort to achieve hemostasis following diagnostic heart catheterization, and thus earlier hospital discharge. Clinical studies supporting the U.S. approval of the 6 Fr Angio-Seal showed reductions in time to hemostasis from an average of 17 minutes in a historical manual pressure group to one minute with the 6 Fr Angio-Seal. St. Jude also said the FDA has approved the Tendril SDX steroid-eluting active fixation pacing lead, using features that permit flexibility in positioning and streamline the implantation procedure. The Tendril SDX pacing lead has a diameter of just 6.2 Fr, permitting the use of a smaller introducer (7 French) and thus a smaller surgical opening and more rapid recovery. The Tendril SDX pacing lead also incorporates a steroid-eluting tip that reduces inflammation and decreases the energy requirements for pacing.

Vascular Genetics (Research Triangle Park, North Carolina) completed enrollment and dosing in three of its clinical trials, one for the treatment of coronary artery disease and two trials for the treatment of critical limb ischemia. The company also said it will not enroll or treat additional patients in its trials of vascular endothelial growth Factor II (VEGF-2) in response to an FDA hold on testing. During the hold period, the company will provide the FDA with results from completed clinical trials.

Vasogen (Toronto, Ontario, Canada) said researchers from the University of Toronto found that VasoCare therapy reduces inflammation in the blood vessel walls and retards the development of atherosclerotic plaque by up to 75%.

Velos Medical Informatics (Minneapolis, Minnesota) reported that its Velos Cardiology and Cardiothoracic Surgery information system has successfully concluded Phase II certification by the Society of Thoracic Surgeons (STS) and is now fully STS certified. The system is scalable to meet a range of customer needs in the cardiovascular market. "STS Phase II certification brings us into full compliance with both the STS and American College of Cardiology database specifications," said John McIlwain, company CEO. Velos develops and markets software products and services for the processing needs of the cardiology, renal, transplantation, oncology specialties, and for enterprise healthcare use.

Zoll Medical (Burlington, Massachusetts) has received 510(k) clearance from the FDA for its M Series defibrillator with End-Tidal Carbon Dioxide (EtCO₂) monitoring. The M Series monitors SpO₂ and EtCO₂ as well as provide an interpretive 12-lead ECG, making it the smallest, lightest device with these capabilities." The M Series EtCO₂ option incorporates Novametrix Medical Systems' (Wallingford, Connecticut) technology, which continuously monitors carbon dioxide and respiratory rate using a solid-state sensor called a Capnostat. The Capnostat is attached to an airway adapter that connects to a disposable mouthpiece, endotracheal tube, or similar airway allowing it to be used on all patients. EtCO₂ is displayed as a numerical value or a capnographic waveform on the M Series. Richard Packer, president and CEO, said, "This new feature adds a monitoring parameter to the M Series device that is extremely important for the treatment and transfer of critically ill and anesthetized patients."