Reflecting the company's new emphasis on the interventional sector, Abbott Laboratories' (Abbott Park, Illinois) last month reported two major forward steps in the product development program of its Abbott Vascular (Redwood City, California) unit. In early April, Abbott Vascular reported that the first patient in the U.S. to be enrolled in its landmark clinical trial to assess the benefits of using stents in the neck arteries of likely stroke patients who have not shown symptoms of the disease was treated at the Hoag Heart and Vascular Institute at Hoag Memorial Hospital Presbyterian (Newport Beach, California).

The ACT I study, also known as the Carotid Angioplasty and Stenting vs. Endarterectomy in Asymptomatic Patients with Significant Extracranial Carotid Occlusive Disease Trial, is the first trial to study the potential benefits of minimally invasive carotid stenting in patients who normally would undergo a carotid endarterectomy (CEA) to prevent stroke. CEA is the current "gold standard" of treatment in asymptomatic patients, along with medication and lifestyle modification. ACT I compares carotid artery stenting to carotid artery surgery in asymptomatic patients i.e., those who have not displayed symptoms of stroke, but who are at risk who normally would be referred for surgery.

"This important clinical trial challenges the final frontier in carotid therapy by comparing carotid stenting with standard CEA in asymptomatic patients," said Subbarao Myla, MD, medical director of cardiovascular research at the Hoag Heart and Vascular Institute and the principal investigator for the ACT I study. "This has enormous importance since approximately 75% of carotid surgery in the country is done on such patients."

Abbott Vascular also reported last month that it had submitted a premarket approval (PMA) application to the FDA for its StarClose Vascular Closure System, what it termed a "next-generation" vessel closure system specifically designed for the mechanical closure of femoral arteries following catheterization procedures, such as angioplasty and stent placement.

The StarClose device is designed to quickly and securely deliver a flexible nitinol clip to mechanically appose or bind the surface of a femoral artery together following a catheterization procedure. StarClose received CE certification in February 2004, and was officially launched outside of the U.S. last year.

Integrated Vascular Systems (IVS; Sunnyvale, California) originally developed the StarClose clip technology and Abbott acquired IVS in September 2003.

Tony Chou, MD, an interventional cardiologist and general manager of vessel closure technologies at Abbott Vascular, said that if approved, the StarClose represents the next revolution in the company's vascular closure offerings. "Our analysis has shown that StarClose is a device that was as safe as manual compression with an extra vascular approach and a design that could potentially minimize the risks associated with other methods of femoral artery closure."

He noted that Abbott already sells the Perclose suture-mediated closure system, which it acquired with the 1999 acquisition of Perclose (also Redwood City). Another product in the company's vascular closure portfolio is the Chito-Seal topical hemostasis pad, which expedites clot formation and accelerates hemostasis. That product was launched in 2002.

Elsewhere in the product pipeline:

Advanced Magnetics (Cambridge, Massachusetts) said that it received an "approvable" letter from the FDA regarding Combidex, its investigational functional molecular imaging agent. The FDA requested additional data to demonstrate the efficacy of Combidex, and suggested that the data be limited to a well-defined population of specific cancer types. The agency indicated that its principal issues relate to topics addressed by the Onocologic Drugs Advisory Committee on March 3, primarily how the data submitted by the company could be generalized across all tumor types.

Advanced Neuromodulation Systems (Plano, Texas) reported FDA approval to market its second rechargeable implantable pulse generator (IPG), the Eon Neurostimulation System. "We will begin to manufacture product to support a limited launch late in the second quarter and a full market launch in the second half of 2005," said President and CEO Chris Chavez, adding that the FDA approval came earlier than expected. The system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs. Chavez said the Eon system "offers the longest projected usage time between battery charges and the fastest recharge rate of any rechargeable IPG on the market." The system can power up to 16 electrodes in a dual eight-electrode lead configuration.

Biomarker Technologies (Phoenix), maker of the blood diagnostic for the detection of breast cancer called the BT Test, reported plans to begin a pilot study of the test in the U.S. beginning in this month. The company said it is conducting the pilot study to verify its prior results and make final preparations for FDA clinical studies. The study will be a retrospective blind test with samples from healthy participants, those with untreated breast cancer, as well as those from a select group of other cancer conditions in order to demonstrate the differentiation capabilities of the test. The BT Test is designed to detect the presence of breast cancer at the molecular level. The test measures five key cancer-associated biomarkers that can detect breast cancer when combined and adjusted for age.

Biophan Technologies (West Henrietta, New York) reported the issuance of U.S. patent No. 6,864,418, "Nanomagnetically shielded substrate," expanding its coverage of nanomagnetic materials licensed from Nanoset (East Rochester, New York). This patent has applications in medical device technology being developed for commercial use by Biophan to protect patients having pacemakers and other similar implanted devices from potential harm due to MRI. This patent focuses on the nanoscale composition, structure, and tuning of nanomagnetic shielding materials, and the effects these design properties have on the way the shield coating performs in the complex and powerful electromagnetic fields used in MRI.

Boston Scientific (Natick, Massachusetts) reported that the FDA has approved enhancements to the Directions for Use of the Taxus Express2 paclitaxel-eluting coronary stent system, indicating that patients receiving the stent systems may safely undergo MRI examination immediately following implantation. The Taxus system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Boston Scientific's Express2 (bare-metal) stent system also received approval for immediate MRI exams. Patients receiving coronary stents have typically been required to wait about two months before receiving an MRI. Testing showed the Taxus Express2 and Express2 systems to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release.

Cambridge Heart (Bedford, Massachusetts) reported that it has received FDA clearance to begin marketing in the U.S. of its new Heartwave II System for the measurement of Microvolt T-Wave Alternans (MTWA), and that the product is now available. The Heartwave II System is a stand-alone device to measure MTWA to help predict an individual's risk of sudden cardiac death. Unlike the original Heartwave System, the Heartwave II does not require a host stress exercise system to control the treadmill or to monitor the patient's ECG or electrical activity of the heart. Running on a Microsoft Windows XP operating system, the look and feel of the Heartwave II is more familiar for the user, the company said. The Pentium processor included in the Heartwave II can process information up to 15 times faster than the original Heartwave, and its increased memory capacity can store 300 times more patient studies.

CHF Solutions (Brooklyn Park, Minnesota) reported the launch of the Aquadex FlexFlow System, the next generation of its technology used to treat fluid overload in patients with renal failure, post-surgical fluid overload, metabolic disease or congestive heart failure. The new system gives physicians greater flexibility and precision in setting blood-flow and fluid-removal rates. The company introduced the Aquadex FlexFlow at the annual conference of the International Society for Heart and Lung Transplantation in Philadelphia. The Aquadex FlexFlow is used to perform aquapheresis, a procedure to safely and predictably remove excess salt and water from fluid-overloaded patients.

ev3 (Plymouth, Minnesota) said it has received approval to include the SpideRX Embolic Protection Device in the second arm of its carotid clinical trial, CREATE (carotid revascularization with ev3 arterial technology evolution). ev3 has completed enrollment in the first phase of this trial using the SPIDER Embolic Device and the Protege GPS Self-Expanding Stent. The 30-day results of the first phase were presented in a late-breaking trials session at the Society of Interventional Radiologists meeting in New Orleans. The second phase of the trial will evaluate the SpideRX device when used with the commercially available RX Acculink Carotid Stent System from Guidant (Indianapolis). The SpideRX Device, like its predecessor product, has a unique nitinol filter. The new device is designed to provide more efficient delivery, capture and recovery, while still allowing interventionalists to use their interventional wire of choice. Improvements over the current device include a complete rapid exchange system, 6 Fr guide catheter compatibility and a dual-end delivery/recovery catheter with a pre-loaded capture wire.

Gambro BCT (Lakewood, Colorado), a wholly owned subsidiary of Gambro AB (Stockholm, Sweden), reported that the FDA has cleared apheresis platelets collected with its Trima and COBE Spectra Collection Systems for routine storage and patient transfusion up to seven days, when tested with the bioMerieux (Lyons, France) BacT/ALERT Microbial Detection System Release Test. Currently all bacterial detection systems are cleared as QC Test systems that only permit five-day storage. When used to test Gambro BCT platelets per the company-specified methods, the BacT/ALERT Microbial Detection System testing is considered a release test for Gambro BCT platelets. This requires the use of both aerobic and anaerobic cultures. To implement seven-day platelets, blood centers will need to work with the FDA to obtain proper approvals to use the BacT/ALERT as a release test. Gambro BCT is sponsoring a post-market surveillance study to further evaluate the performance characteristics of this testing system.

Medtronic (Minneapolis) reported the introduction of the Attain Select 6238 TEL Guide Catheter Set that aids in the safe and effective implantation of device leads in the veins that serve the left side of the heart for the treatment of heart failure. The Attain Select products, now available in the U.S., Europe and Canada, are specialized to give physicians a range of choices as they work from outside the body to select the most appropriate cardiac veins leading to the heart's lower left chamber and safely maneuver an insulated lead through them to carry electrical impulses from an implanted cardiac resynchronization therapy device. The set includes catheters in three shapes: one shaped with its tip in a 90-degree curve and another with a 180-degree curve, and a straight catheter to aid in cannulation of the coronary sinus or in crossing partially blocked or narrowed veins. The catheters' softer tips are designed to reduce risk of trauma to blood vessels and their smaller inner lumens (0.040" diameter) provide precise tracking over any guidewire with up to a 0.035" diameter. The Attain Select catheters are designed to fit inside current Medtronic Attain catheters that are used for coronary sinus cannulation.

Nanogen (San Diego), developer of advanced diagnostic products, reported that it was issued U.S. patent No. 6,864,071 by the U.S. Patent and Trademark Office. The patent relates to amplifying and analyzing multiple samples of nucleic acid using ligation-based strand displacement amplification (SDA) technologies. The intellectual property pertains to research Nanogen conducted in collaboration with Becton Dickinson (Franklin Lakes, New Jersey) and increases Nanogen's portfolio of technologies for multiplex amplification on a chip.

Orthovita (Malvern, Pennsylvania) reported being granted a U.S. patent covering the development and use of composite shaped bodies for a range of applications in orthopedic surgery. The patent covers nine new claims for composite implants, including the use of Orthovita's Vitoss Bone Graft Substitute in combination with a medicament such as a protein or antibiotic. The patent also covers the development of composite implants using Vitoss in combination with other synthetic biomaterials such as Orthovita's Cortoss Synthetic Cortical Bone. The patent protection also covers the use of Vitoss in combination with inorganic fillers or with polymers such as polycaprolactone, poly-L-lactic acid or polyglycolic acid.

RITA Medical Systems (Mountain View, California) said that an article published in the Journal of Clinical Oncology reported long-term survival rates for 135 patients treated with radio frequency ablation (RFA) for hepatic colorectal metastases at the Cleveland Clinic (Cleveland). The study enrolled people with metastatic colorectal cancer who had progressed despite prior chemotherapy treatment. The authors concluded that the results of the study suggest the addition of RFA to modern chemotherapy provides "a survival advantage when compared to chemotherapy alone." The authors noted that while surgical resection is still the gold standard for treatment, "only 10% to 20% of [colorectal liver metastases] patients are candidates for resection because of extensive disease or medical co-morbidities." The company said that the results of the study may have the effect of expanding the population of patients with colorectal liver metastases considered candidates for the procedure because extra-hepatic disease was shown to not negatively impact survival.

Siemens Medical Solutions (Mountain View, California) introduced the all-digital Sonoline G40 ultrasound imaging system. Siemens said the G40 combines "best-in-class" image quality, workflow advancements and color Doppler capabilities to meet daily clinical needs in a variety of settings, including general imaging, obstetrics/gynecology and internal medicine. Embedded connectivity solutions allow simple integration into DICOM-enabled networks and PC-based workstations. The compact, mobile ultrasound system features color Doppler and pulse-wave Doppler capabilities. Phased array technology also expands clinical capabilities to include cardiac survey and small-footprint abdominal imaging. Other advances include Virtual Format Imaging, which offers a variety of linear, trapezoidal and steered 2-D imaging formats. The G40 system is expected to be available for purchase next month.

Thermage (Hayward, California) said a physician panel of cosmetic surgery experts presented the latest scientific advances in capacitive radio frequency (RF) skin rejuvenation using its ThermaCool device at the American Academy of Dermatology meeting in New Orleans in February. Thermage's RF is FDA-cleared for the treatment of facial rhythids and wrinkles. Research presented at the meeting on Thermage usage showed safe and effective treatment of wrinkled eyelid skin with a specialized treatment tip; potential new applications to tighten and contour lax skin on the abdomen and other body areas; and measurable evidence of tissue tightening and lifting with associated patient satisfaction.

Toshiba Medical Systems (Tokyo) reported the beginning of patient evaluations in what it said is the industry's first multi-center clinical study on coronary computed tomography angiography (CTA) imaging using 64-slice CT technology. Initial results of the study will be released in 2006. In November 2004, Toshiba launched CorE 64 (Coronary Evaluation on 64), an international collaboration with its partners to investigate the use of multislice CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders, as compared to cardiac catheterization. The patient evaluations will involve non-invasive diagnostic imaging of cardiac patients using Toshiba's CT technologies, such as the Aquilion CFX 64-slice CT, 64-row Quantum Detector and SURECardio and SUREPlaque applications for a period of several months, as well as regular meetings with the study group to measure and discuss the clinical effectiveness of cardiac CT imaging against cardiac catheterizations. Separately, Toshiba America Medical Systems said clinical researchers at Beth Israel Deaconess Medical Center (BIDMC; Boston) reported the completion of the first chest pain evaluation using electrocardiogram-gated (ECG-gated) imaging performed with the Toshiba Aquilion 64. Featuring advanced multi-detector computed tomography technologies, the Aquilion 64-detector CT uses Toshiba's 64-row Quantum detector, which enables the Aquilion CT scanner to acquire 64 simultaneous slices of 0.5 mm for precise volumetric imaging of any region of the body during a breath-hold under 10 seconds.