Resverlogix (RVX; Calgary, Alberta), developer of compounds for use with medical devices, has found a partner for its early-stage pharma technology, ReVas, for a large cardiovascular application. The company will work with Medtronic (Minneapolis), to create a drug-eluting (DES) stent, as the med-tech titan seeks to be the third to enter the DES derby.

The companies said they will begin the work by completing development of the technology. If they agree to move forward with additional product development, Medtronic would make an initial cash payment to RVX, a subsidiary of Resverlogix, followed by milestones and royalties.

All told, RVX could receive up to C$340 million ($291 million).

“It’s the largest preclinical deal ever done in Canada,” Don McCaffrey, co-founder and president/CEO of Resverlogix, told Cardiovascular Device Update.

Resverlogix also gets to play a part in the burgeoning drug/device combination market, which already has produced the Taxus paclitaxel-DES from Boston Scientific (Natick, Massachusetts) and the Cypher sirolimus-DES from Cordis (Miami Lakes, Florida).

Medtronic’s Zotarolimus- (Abbott) DES, Endeavor, is finishing up clinical development for a U.S. application.

The stents all use “a version of either rapamycin or paclitaxel,” McCaffrey said. Since both of those are oncology drugs, “they’re a little harsh on the endothelial lining in the artery.”

He added that while those drugs might be effective in preventing restenosis, “at 90 days out, you’re seeing some thrombotic issues, some ruptures and, in some cases, death.”

Others, both cardio researchers and analysts, have noted that the ability of DES devices to reduce mortality, long-term, is yet to be shown and that the short-term benefit, thus far, has been their proven ability to reduce the number of stent placement re-dos.

Resverlogix’s ReVas program is aimed at designing a drug that “actually encourages the healing of the endothelial lining,” in addition to reducing the smooth-muscle cell proliferation that leads to restenosis, McCaffrey said. “So, it’s kind of a new-generation drug for the stent market.”

ReVas emerged when researchers discovered hydrophobic compounds while working on its NexVas cholesterol program. Since those compounds were unable to reach the liver or small intestine, they were useless as cholesterol drugs, but their non-systemic quality made them ideal for drug/device combos.

“Being hydrophobic and staying in the arteries is actually quite an advantage for this type of medication,” McCaffrey said.

To keep its ReVas program separate, Resverlogix established the RVX subsidiary last year. RVX also holds the intellectual property relating to Resverlogix’s TGF-Beta Shield technology for cancer and fibrotic diseases.

Elsewhere in the product pipeline:

• AtriCure (West Chester, Ohio) reported that it has received FDA 510(k) clearance for its Isolator Transpolar Pen System for pacing, sensing, stimulating, and recording during the evaluation of cardiac arrhythmias in addition to its currently FDA-cleared use for the ablation of cardiac tissues. The new capabilities of this multifunctional pen allow physicians to identify potential trigger areas on the heart that could cause cardiac arrhythmias. Physicians may ablate these targeted cardiac triggers and directly evaluate the effectiveness of the ablation, all with the same device. The multifunctional system includes specialized electrophysiology accessories that enable physicians to toggle between each function. Separately, the company reported the release of its new Isolator Transpolar open clamp, which leverages the design enhancements of the Isolator minimally invasive system released during 1Q06. The open clamp features a design that improves the surgeon’s access to key anatomical structures, simplifies the ablation procedure and provides superior tactile feedback to the user. The clamp currently has clearance from the FDA for the ablation of soft tissues in general, thoracic and other non-cardiac related surgical procedures.

• BioSphere Medical (Rockland, Massachusetts), a developer of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations via embolization, said that the FDA has cleared its EmboCath Plus Infusion Microcatheter and it is expected to begin shipping in the U.S. next month. Richard Faleschini, president/CEO, said the EmboCath Plus “is designed to provide exceptional performance in the delivery of embolic, diagnostic and therapeutic agents into the peripheral vascular system for interventional procedures such as uterine fibroid embolization and the embolization of hypervascularized tumors. [It] was designed for use with BioSphere’s existing and planned new products, including the Sequitor Steerable Guidewire, which received FDA approval in June ... our currently marketed Embosphere Microspheres, EmboGold Microspheres and our QuadraSphere Microspheres product candidate, for which we have submitted a 510(k) pre-market notification to the FDA.”

• Cardiovascular Systems (St. Paul, Minnesota) reported that the FDA has approved the expansion of the OASIS clinical trial following review of the safety data from the feasibility phase of the study. The OASIS trial is being conducted to gather safety and effectiveness data on the Orbital Atherectomy System (OAS). OAS is a catheter-based system that uses a diamond-coated crown to remove plaque from peripheral arteries. The novel design of the OAS allows the crown to create a final lumen about twice the size of the crown. The company said OASIS is the first prospective multi-center clinical trial for an atherectomy device treating peripheral arterial disease.

• Cook (Bloomington, Indiana) has a somewhat different approach in the drug-eluting stent combination, impregnating the drug within a device – only in this case for preventing the much-feared infection involved with the use of central venous catheters. And the company has combined this with a multi-lumen approach to avoid the multiple ways in which the use of catheters may lead to serious catheter-related bloodstream infections (CRBSI). The company has reported rollout of its new five-lumen, drug-impregnated central venous catheter, the next-generation Spectrum, designed to both improve multiple treatment administration and to provide increased protection against hospital-based CRBSI. The device received FDA 510(k) clearance in February. This latest version of the Spectrum incorporates five non-communicating vascular access lumens within a single catheter body to reduce the necessity of performing multiple venipunctures or multiple stopcock configurations using single-lumen catheters.

• Corgenix Medical (Denver), a developer of diagnostic test kits, said it has submitted a pre-market notification to the FDA for the company’s AspirinWorks Test Kit, the company’s newest diagnostic product for cardiovascular disease. AspirinWorks is a simple urine test that measures an individual’s response to aspirin dosage and allows physicians to adjust the dosage or recommend alternative therapy. The AspirinWorks Test Kit is a quantitative enzyme-linked immunoassay to determine levels of 11-Dehydro Thromboxane B2 in human urine, which aids in the assessment of the response to aspirin. The AspirinWorks product was developed in conjunction with Corgenix’ strategic partners, Creative Clinical Concepts (Denver), a biotechnology company, and Cayman Chemical (Ann Arbor, Michigan), a manufacturer of biochemical research products.

• FlowCardia (Sunnyvale, California), a company focused on coronary and peripheral catheter-based systems for chronic total occlusion (CTO) recanalization, said it has completed enrollment in the FlowCardia’s Approach to Chronic Total Occlusion Recanalization (FACTOR) pivotal study. The 19-hospital, 125-patient study was designed to assess the safety and efficacy of the company’s Crosser catheter in chronically occluded coronary arteries. Wick Goodspeed, president and CEO, said, “We hope to file a request for Crosser 510(k) clearance in September [and] anticipate clearance from FDA before the end of this year.” FlowCardia also said that it received approval from the FDA to start the pivotal phase of the Peripheral Approach To Recanalization In Occluded Totals (PATRIOT) study after completion of the feasibility phase in June. The 10-hospital, 85-patient U.S. pivotal study is designed to determine the safety and efficacy of the Crosser catheter in totally occluded peripheral arteries. The Crosser System is a monorail catheter delivered over standard guide wires to the site of a CTO. It uses high-frequency, mechanical vibration and is designed to facilitate crossing of CTOs, allowing for subsequent debulking, balloon angioplasty and stent placement.

• The Sorin Group (Milan, Italy) has released in the U.S. the successor to its SIII perfusion system, the S5. The Stockert S5 is a fifth-generation heart-lung machine, coming from Stockert and Cobe Cardiovascular (Arvada, Colorado) brand technologies. Sorin said the product is expected to help hospitals achieve new standards for safety, functionality, flexibility and quality. U.S. cardiac surgery teams now have access to the S5 along with the Stockert Heater-Cooler System 3T, used to control patients’ temperature during cardiac surgery and also recently cleared for sale in the U.S. The smaller footprint of the S5 allows closer positioning of the unit to the patient, effectively reducing line lengths and the possibility of hemodilution. In addition, acoustically differentiated alarms and information displayed on the high-resolution touch screens clearly describe the status of all monitoring functions of the extracorporeal circuit. With the Stockert S5, there is no boot-up time, so the pumps are operable three seconds after turning the system on, which is important in emergency situations, the company said. During bypass, the Stockert Heater-Cooler System 3T controls the temperature of the patient while separately controlling the temperature of the heart using independent water baths that are controlled by an extremely quiet and effective compressor system.

• W. L. Gore & Associates (Flagstaff, Arizona) said site initiation and enrollment has begun in the Embolic Protection with flow Reversal (EMPiRE) clinical study. This investigational study is designed to demonstrate the safety and efficacy of the Gore Neuro Protection System when used for embolic protection during carotid artery stenting procedures. The first patients were enrolled and successfully treated for narrowing of the carotid arteries at the University of Buffalo (Buffalo, New York). The patients all recovered from their procedure without incident, and have been discharged from the hospital. The system operates on the principle of reversing the flow of blood at the treatment site. Unlike available embolic protection devices, flow reversal enables physicians to perform carotid interventions knowing that liberated emboli will be safely directed away from the brain. Flow reversal is achieved at the treatment site by selectively occluding common carotid and external carotid artery blood flow.

• Medafor (Minneapolis) reported that its MPatcH vascular closure system is now available in Europe, Africa, the Middle East, Central and South America, and the Asia-Pacific region. MPatcH is a topical vascular closure system for patients undergoing diagnostic and interventional cardiologic procedures. The patch uses Medafor's microporous polysaccharide hemospheres technology, which dehydrates blood at the wound site, creating rapid hemostasis and resilient clotting. The company said this "significantly reduces" the time for hemostasis vs. manual compression in vascular access procedures.

• Medtronic (Minneapolis) said a study published in this week's American Heart Association journal, Circulation, provided evidence of the safety and effectiveness of the Medtronic Endeavor drug-eluting coronary stent system for patients with coronary artery disease, with a clinically significant treatment effect that is being sustained over time. The trial enrolled 1,197 patients at 72 facilities in 17 countries and was the first and largest drug-eluting stent trial outside the U.S. comparing a drug eluting stent to a bare-metal stent. "These excellent clinical outcomes have been maintained at nine months, 12 months and 24 months. Compared to bare-metal stents, Endeavor is safe and effective in reducing the rates of clinical and angiographic restenosis, and is a highly deliverable stent that has significant anti-restenosis properties and a favorable safety record with dual anti-platelet therapy," said William Wijns, MD, the co-principal investigator of the trial.

• Omnicell (Mountain View, California) introduced new case-, product- and patient-tracking enhancements to its OptiFlex CL supply management system for hospital cath labs, endoscopy and other special procedure units. The company said the enhanced version of OptiFlex CL was successfully beta tested at St. Patrick Hospital and Health Sciences Center (Missoula, Montana). OptiFlex CL is an area management system with real-time point-of- use data collection that tracks supplies and procedures to the physician for cost management and automated charge capture. It is an integrated system for managing supplies in closed cabinets and open shelves in hospital cath labs, endoscopy and other special procedure units, and the OptiFlex platform also includes configurable modules for hospital medical-surgical and surgical services units.

• Pressure Products (San Pedro, California) reported the availability of SoftTouch. The SoftTouch device provides protection to those with a pacemaker, defibrillator or chemotherapy port implant while wearing a seat belt. Pressure Products produces hemostatic vascular access sheaths and devices for managing femoral punctures and wound access management.