Providing a hiatus last month from the often-gloomy news surrounding Guidant (Indianapolis), the company reported completing enrollment in its 300-patient SPIRIT II drug-eluting stent (DES) clinical trial, just four months after the company announced it was initiating enrollment. Enrollment completion puts it a step closer to entering the DES market in the U.S.

SPIRIT II is a randomized clinical trial evaluating Xience V, an everolimus eluting coronary stent system utilizing Guidant’s cobalt chromium rapid-exchange Multi-Link Vision coronary stent system platform. This single-blind, prospective, randomized, non-inferiority study further evaluates the Xience V compared to Boston Scientific’s (Natick, Massachusetts) Taxus Express 2 paclitaxel-eluting coronary stent system for the treatment of coronary artery disease (CAD). The primary endpoint of the trial is in-stent late loss at six months.

“SPIRIT II will provide additional important data about the combination of everolimus and our most advanced coronary stent system, the Multi-Link Vision coronary stent system for the treatment of coronary artery disease in a more challenging patient population,” said John Capek, PhD, president of Guidant’s Vascular Intervention business. “SPIRIT II completed enrollment in just four months,” he added, calling it “an achievement that illustrates the capabilities of Guidant’s clinical organization and the dedication of the investigators from Europe, India, South Africa and New Zealand to the XIENCE V program and to the SPIRIT II trial.”

Patrick Serruys, MD, PhD, of the Thoraxcenter (Rotterdam, the Netherlands), who serves as the trial’s principal investigator, said in a company statement that the SPIRIT II trial “will continue to evaluate the clinical experience of Xience V, which demonstrated excellent six-month results in the SPIRIT FIRST trial reported last fall.”

Guidant also reported that the U.S. arm of the SPIRIT III trial had enrolled 400 patients of a planned cohort totaling 1,002. SPIRIT III is a 1,380-patient global clinical trial evaluating the Xience V in the U.S. and Japan. The 1,002-patient randomized portion in the U.S. is a prospective, single-blind trial comparing Xience V vs. the Taxus Express 2 system. Results of SPIRIT III, which began enrollment in June, are expected to support FDA approval of the Xience V Stent System and Ministry of Health and Welfare approval in Japan.

Elsewhere in the product pipeline:

• Abiomed (Danvers, Massachusetts), a manufacturer of medical products designed to assist or replace the pumping function of the failing heart, reported data presented at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics scientific symposium in Washington on its Impella Recover LP 2.5, a minimally invasive percutaneous ventricular unloading catheter. The single-center experience at the Academic Medical Center (Amsterdam, the Netherlands) of 21 patients has found that using the Impella as a left ventricular assist device during high-risk angioplasty/stenting procedures is both safe and feasible, providing hemodynamic support and improving coronary circulation, without compromising coronary blood flow. The results were described in two presentations: one that confirmed the safety and feasibility of using the Impella Recover LP 2.5 as a left ventricular support in patients undergoing high-risk angioplasty/stenting procedures; and another that showed that the CE-marked Impella Recover not only unloads the heart but that can also increase coronary perfusion needed to provide oxygen to the heart itself, in a study of 11 patients undergoing high-risk angioplasties.

• Alliance Medical (Phoenix), a reprocessor of single-use medical devices, reported FDA clearance for Alliance to reprocess Siemens Medical Solutions’ (Malvern, Pennsylvania) AcuNav Ultrasound Cath-eter, which is used in the diagnosis of certain cardiac arrhythmias. Rick Ferreira, president of Alliance Medical, said the reprocessing program for the catheter would save its cath lab partners more than $1,500 per procedure.

• CardioMEMS (Atlanta), focused on the application of microelectromechanical systems (MEMS) technology to create devices for the diagnosis and management of chronic diseases, reported FDA clearance and launch in the U.S. of the EndoSure Wireless AAA Pressure Measurement System. The system is based on the latest innovations in both MEMS and wireless technologies, and comprises the Endosure Sensor; a delivery catheter; an external interrogation device and proprietary software. The Endosure sensor is the first wireless, un-powered, permanently implantable pressure sensor for human use to be commercially available in the U.S, the company said. The sensor is implanted during the endovascular aortic repair procedure and is compatible with all commercially available stent-grafts. To take a pressure measurement within the aneurysm sac, the antenna is placed on the abdomen and activates the sensor using low power radio frequency energy. A real-time, high-resolution pressure waveform is quickly displayed on a 15-inch flat-panel touch screen monitor.

• CoreValve (Paris) reported that it has reached 140 million cycles in its accelerated cycling protocol related to its porcine pericardium aortic heart valve for its ReValving System for percutaneous aortic valve replacement (PAVR). The company said successful mechanical testing is a critical step in the certification of CoreValve’s ReValving approach to PAVR as a future alternative to open-heart surgery. The company said it is more than half way to meeting the U.S. regulatory requirement of 200 million cycles, expected to be reached by year-end.

• CPC of America (Sarasota, Florida) reported that its subsidiary, Med Enclosure, was informed by the FDA that its MedClose Vascular Closure System (VCS) would be regulated under the medical device regulations, and the lead center would be the Center for Biologics Evaluation and Research (CBER). On Aug. 8, company said it was asked to submit a request for designation (RFD) to the FDA’s newly formed Office of Combination Products. The company also was given a list of minor deficiencies resulting from the FDA’s review of its investigational device exemption and told that further review was stopped until the lead center had been determined. CPC submitted an RFD on Aug. 17. While the company said it is pleased that the MedClose VCS will be held to the same regulations as all prior vascular closure devices, it said it disagrees with the decision that CBER should be assigned lead responsibility for regulating this medical device. Med Enclosure has requested that the OCP reconsider its decision, and re-assign the Center for Devices and Radiological Health (CDRH) as the lead center for regulating the product, just as it has regulated all prior vascular closure devices. The company said it believes that these administrative issues will be resolved quickly, and regardless of which center is assigned lead responsibility for regulating the MedClose VCS, that the IDE authorizing the start of the MedClose clinical trial will soon be approved. The MedClose VCS is a catheter-based system that uses fibrin sealant to rapidly seal arterial puncture sites following angiography and angioplasty.

• Endologix (Irvine, California) reported that the first patients have been treated in the company’s infrarenal clinical trial using a 34 mm diameter cuff with the Powerlink Bifurcated System. The three minimally invasive surgical procedures were performed at Lexington Medical Center (West Columbia, South Carolina) as part of the seven-center, 60-patient trial. The Powerlink System is a bifurcated endoluminal stent graft approved by the FDA for the minimally invasive treatment of abdominal aortic aneurysm (AAA). Endologix also is conducting an ongoing suprarenal clinical trial using the Powerlink 34 mm Bifurcated System, a modification of Endologix’s FDA-approved Powerlink System, which is an alternative or potentially complementary technology to treat AAA patients with large-diameter aortic necks.

• InterCure (Fort Lee, New Jersey), which develops products for the treatment of hypertension, heart failure, respiratory diseases and other conditions, said an interim analysis of the results of the first 38 patients participating in a randomized, controlled study of non-insulin-dependent diabetics with uncontrolled blood pressure was presented recently at the European General Practice Research Network meeting. The study compared the blood pressure response to eight weeks of 15-minute daily self-treatment with device-guided slow breathing using the company’s RESPeRATE device with that of a control group that continued their usual care. Medication, diet and physical exercise were unchanged in both groups during the study. Results show a significant reduction in systolic blood pressure of 7.4 mmHg in the treatment group, compared to a rise of 3.1 mmHg in the control group. Some 32% of the RESPeRATE-treated patients reached the target BP of 130/80 mmHg compared with just 5% in the control group.

• MedicalCV (Minneapolis) reported receiving FDA 510(k) clearance for its Malleable Surgical Ablation Probe for use on cardiac tissue in surgery. This second-generation product provides surgeons desired flexibility in delivering laser energy in confined spa-ces, the company said. MedicalCV is focused on dev-eloping a minimally invasive procedure for the treatment of atrial fibrillation by using a platform of laser-based technology for cardiac tissue ablation in surgery.

• Millar Instruments (Dallas) reported the addition of the SPR-1000, a Mikro-Tip pressure transducer catheter with a 1 Fr size, to its line of ultra-miniature pressure catheters for use in small-animal research. The company said the SPR-1000 is the smallest sensor tip pressure catheter available on the market. It said the smaller diameter minimizes the obstruction of blood flow in the vessel and allows for improved surgical access to the right ventricle, pulmonary artery and peripheral areas.

• Welch Allyn (Skaneateles Falls, New York), a manufacturer of frontline medical products and solutions, reported the introduction of two multichannel electrocardiographs. In addition to administering patient tests and managing patient information, the Welch Allyn CP 100 and CP 200 devices offer flexible report formatting, inexpensive patient test storage and intuitive design and functionality, the company said. Both units can interface with Welch Allyn’s CardioPerfect Workstation Software to transfer patient data from the device to an electronic medical record. The CP 100 is a non-interpretive, 12-lead resting ECG with an optional MEANS ECG interpretation software package that offers physicians a “second opinion.” The CP 200 has the same features as the CP 100, and a full-color display and dedicated function keys that speed access to common actions. The CP 200 also has an optional spirometer module that performs FVC, SVC and pre- and post-bronchodilator testing with automatic interpretation and reversibility analysis.

• Zargis Medical (Princeton, New Jersey), a dev-eloper of computer-aided medical devices, reported the issuance of U.S. patent No. 6,953,436, “Multi-modal cardiac diagnostic decision support system and method,” which describes a method of extracting and evaluating features from cardiac acoustic signals and a means for determining whether or not the sounds are innocent or indicative of disease based on expert rules. Zargis said the inventions covered by the patent could aid a physician in detecting valvular heart diseases that might otherwise go undiagnosed, discriminating pathological from innocent heart murmurs and making better patient referral decisions while documenting the basis for the decision.