On the one hand is the “winged chariot” of time, a vehicle that the FDA can slow rather substantially – and often does. On the other hand is initial public offering (IPO) money that fuels the machine and expects accelerated results. Those are the contending forces facing Cardica (Redwood City, California) – and, of course, many other device makers – as it reports launch of a new study that it hopes will lead to clearance of its PAS-Port Proximal Anastomosis System suturing system in coronary artery bypass grafting (CABG) procedures, best-case scenario as early as early 2008, according to Bob Newell, company CFO.

In April 2005, Cardica went before the FDA’s cardiovascular panel and, while it didn’t get a formal vote against recommending the PAS-Port, it was told to go back to the regulatory drawing board and develop more data, the panel pointing to “gaps” in the data that had been pooled from two studies.

The result for Cardica: as much as a two-year delay in product commercialization. “After the meeting, we withdrew our 510(k),” and then returned to the agency to win an investigational device exemption for a new study, Newell told Cardiovascular Device Update. That has taken some time, working with the FDA on a new protocol, he said.

In the meantime, the company was the first pure device firm in 2006 to launch an IPO, gathering in, with sale of over-allotments, $32.6 million, a move that helps it push forward with its study but also puts on some pressure, via public disclosures and the close scrutiny of shareholders, Newell acknowledged. It’s now “life in a fish bowl,” he said. “But for us it’s worth it, because the company is [now] capitalized in a way that we can move forward.”

The company’s new pivotal trial will enroll 220 patients at 10 centers in the U.S. and Europe, with the procedures using both the PAS-Port system and a hand-sewn suturing procedure in each patient to provide the study comparison – the vessels themselves randomly chosen, Newell noted.

The results will be compared using angiograms, with the company hoping to file its new 510(k) application to the agency by late 2007, potentially winning clearance in early 2008.

The PAS-Port system – already commercially available in Japan and Europe – creates a connection between a vein graft and the aorta, the main artery in the body, as part of the CABG procedure.

The current method of performing an anastomosis in a CABG procedure utilizes demanding and time-consuming hand-sewn sutures to connect a bypass graft vessel to the aorta and to small diameter coronary vessels.

Newell noted that besides showing that the PAS-Port provides as good a connection as hand suturing, it could cut a majority of minutes off the procedure time – requiring just two minutes, compared to the seven to 15 minutes for the hand-done procedure, as reported in the literature, he said.

Newell said this additional speed comes from the integration of processes that the system provides – “cutting the hole in the artery, pulling the plug out of the aorta, inserting the implant with vein graft attached, all in a matter of seconds. What really takes up the two minutes is loading and preparation.”

Elsewhere in the product pipeline:

• Abiomed (Danvers, Massachusetts) reported FDA approval of its pre-market approval supplement for the company’s new integrated cannula system. The cannula has the potential for use off-pump with minimally invasive procedures and is designed to integrate with Abiomed’s AB5000 and BVS 5000 Circulatory Support Systems. The new cannula system is easier to implant and explant and is expected to standardize surgical procedures for acute heart failure patients. Abiomed’s cannula system provides an enhanced benefit, since patients will not require a second sternotomy during off-pump explantations. The new system consists of a 42 Fr cannula, surgical sewing cuff and an inline connector for precise implantation and reduced blood loss for patients in acute heart failure. The apical cannulation system is designed to simplify and minimize blood loss during implantation and explantation. A key feature is a sliding seal that helps to control bleeding during procedures.

• Ample Medical (Foster City, California), which manufactures endovascular medical devices for repairing heart valves, reported the first human implants of its PS3 System. The two successful implants, performed at University Hospital (Caracas, Venezuela) mark the initiation of the clinical phase for the PS3 System. The PS3 System was implanted in two patients prior to open-heart surgery then removed during the surgical procedure. In both patients, the intended surgical intervention included repair of the mitral valve with an annuloplasty ring. The PS3 System is an investigational device for the percutaneous endovascular repair of congestive heart failure-related mitral valve regurgitation.

• Biosense Webster (Diamond Bar, California) said the FDA cleared for marketing under a 510(k) application a technology designed to help physicians diagnose and plan treatment for patients with cardiac arrhythmias. The Carto RMT V8 System from Biosense Webster and the Niobe Magnetic Navigation System from Stereotaxis (St. Louis) provide electrophysiologists with automated 3-D mapping and navigation tools, and a magnetic steering platform. Among the enhanced offerings of the system integration are real-time feedback in guiding the catheter to the target, as well as simultaneous display of the NaviStar RMT Catheter on Carto RMT System and Niobe Screens, and bi-directional communication between the two technologies. The new system and catheter provide greater efficiency and better signal resolution, reduced redundancy in data entry and increased reproducibility through automation, the company said.

• Cytori Therapeutics (San Diego) reported top-line preliminary results demonstrating that adipose-derived stem and regenerative cells from its Celution system was safe and improved heart function in a chronic ischemia model, representing a severe form of coronary artery disease. In this blinded, randomized study, seven pigs received their own adipose stem and regenerative cells or a saline injection. Autologous adipose stem and regenerative cells were ex-tracted and concentrated using the Celution system, Cytori’s automated cell processing system. The cells were then delivered via the Noga Mapping and delivery system directly into the ischemic sites. Thirty days following treatment, the cell treated group exhibited a 13% absolute improvement in ejection fraction over the control group. Consistent with this functional improvement, heart structure was preserved as evidenced by a 37% thicker ventricular wall in the cell treated groups, vs. the control. The full data and analysis of this study will be presented later this year.

• FlowCardia (Sunnyvale, California), which is focused on catheter-based systems for the recanalization of coronary and peripheral chronic total occlusions (CTO), reported the completion of enrollment in the PATRIOT (Peripheral Approach To Recanalization In Occluded Totals) feasibility study. The four-hospital, 40-patient U.S. PATRIOT study was designed to assess the safety and efficacy of FlowCardia’s Crosser Catheter in totally occluded peripheral arteries. The Crosser System is a monorail catheter delivered over standard .014” and .018” guidewires to the site of a chronic total occlusion. The Crosser uses high frequency, mechanical vibration and is designed to quickly cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. For many patients, this minimally invasive, endovascular approach to CTO recanalization may eliminate the need for bypass surgery or amputation.

• FoxHollow Technologies (Redwood City, California), which has developed a minimally invasive method of removing obstructive plaque and restoring blood flow to the legs and feet, said a 65-year-old diabetic female with severe leg pain was the first patient to be enrolled in a new clinical trial. SWIFT is a non-randomized, multi-center study assessing the long-term outcomes for patients with peripheral arterial disease (PAD) treated with the SilverHawk Plaque Excision System. After treatment with plaque excision, 100 patients will be followed for a year using duplex ultrasound, and in some cases, also will be evaluated using CT angiography. The company also reported a new randomized, controlled, multicenter study set to begin later this year. The PROOF study will compare SilverHawk to open surgical bypass for patients who are at extremely high risk for limb loss due to a severe form of PAD known as critical limb ischemia. In addition, FoxHollow is supporting a number of studies related to its expanding biologics program. The largest of these studies is LEAP, a multicenter, multiarm trial involving patients who have arterial blockages in both of their legs.

• Kensey Nash (Exton, Pennsyvlania) reported that it has received FDA 510(k) clearance for its next-generation TriActiv FX Embolic Protection System. The product is expected to be launched shortly. The clearance was based on data collected from the ASPIRE (Angioplasty in SVGs with Post-Intervention Removal of Embolic Debris) study which demonstrated that major adverse cardiac events were reduced to 3.2% by using the TriActiv FX System as an adjunct to stenting in treating saphenous vein grafts. The company said the TriActiv is the only distal embolic protection system that actively removes the debris from the vessel by gently flushing the treatment area within the vessel.

• InterCure (Fort Lee, New Jersey) reported RESPeRATE Duo, a new version of its RESPeRATE –the only non-drug treatment device clinically proven to lower blood pressure. The Duo version of RESPeRATE provides the same blood pressure-lowering benefits as the single-user RESPeRATE, but offers new memory functionality for two members of a household to personalize the device and track their progress individually, guiding each of them to a lower blood pressure. FDA-cleared for over-the-counter sale, RESPeRATE Duo guides users through a series of paced breathing exercises that lower blood pressure by gently relaxing constricted blood vessels.

• Lumen Biomedical (Plymouth, Minnesota) said that it has received FDA clearance to market its first product in the U.S., the Xtract Aspiration Catheter. The new device is indicated for use in the removal of thrombi and soft emboli from vessels throughout the body. The Xtract, a single-use, 0.014” guidewire compatible, temporary intra-vascular extraction and aspiration catheter system, can be used with other devices during vascular intervention procedures to restore normal blood flow after blockages created by clots within the vessels. The Xtract also will be part of the company’s FiberNet Embolic Protection System, currently under clinical evaluation in the U.S.

• Luna Innovations (Roanoke, Virginia), which is developing molecular technology and sensing solutions, said it has introduced a medical device that uses quantitative ultrasound technology to noninvasively count emboli in the blood stream. Luna’s EDAC (Embolus Detection and Classification) Quantifier system uses advanced ultrasound technology to detect individual microemboli at rates up to 1,000 per second. Employing missile-tracking algorithms, the system is designed to provide cardiothoracic surgeons, perfusionists and anesthesiologists with an accurate rate of emboli in the blood circuit. The initial release of the EDAC Quantifier system was launched in May and is currently for investigational use only.

• Orqis Medical (Lake Forest, California), a clinical-stage company developing devices for the treatment of heart failure, reported that it has been awarded its twelfth U.S. patent, further strengthening its position surrounding device systems to treat heart failure. The new patent covers key technology for the company’s Cancion System, an investigational percutaneous treatment for acutely decompensated patients with chronic heart failure. The Cancion System is CE-marked and is currently under an investigational device exemption investigation in the U.S. in the pivotal MOMENTUM trial.

• Roche Diagnostics (Indianapolis) reported that its newest coagulation monitoring system, the CoaguChek XS system for physician’s office use, has been submitted to the FDA for 510(k) clearance. The CoaguChek XS system is a small, hand-held, easy-to-use instrument for prothrombin time/ INR testing. It provides fast results – in about a minute – and requires only one drop of blood from the fingertip. The test strip was designed with built-in controls, which it reads to determine strip integrity. The strips can be dosed on the top, right or left side, making it easier for patients to apply blood. The CoaguChek XS system gives information about a patient’s level of anticoagulation directly on the spot and allows their healthcare professional to adjust, if necessary, the doses of medication to a level that reduces the risk of major complications.

• Symphony Medical (Laguna Hills, California) said it is starting patient enrollment in a Phase II multi-center trial of its treatment for post-operative atrial fibrillation (AF), a problem that plagues patients and cardiovascular surgeons, occurring in more than 30% of coronary artery bypass patients and up to 60% of patients who undergo a combination valve replacement and bypass science. The company, a developer of biologic and biopolymer therapies for atrial fibrillation, said its treatment for AF is “non-destructive.” The goal for the treatment, other than the hoped-for benefits relative to patient care, is to reduce hospital length of stay and cost of care. “Physicians recognize the acute and long-term implications related to post-operative AF, including the potential for higher incidences of post-op stroke and the development of chronic atrial fibrillation,” said Raymond Cohen, CEO of Symphony Medical. Cohen, who also serves as chairman of Cardiac Science (Bothell, Washington), was named to the Symphony Medical position in late May. He added that cardiologists are “virtually unanimous in their view that a prophylactic approach that prevents post-op AF treatment.” He said that cardiologists consider the current standard of care – administration of drugs – as, “at best, inadequate and ineffective.”