Medical Carbon Research Institute (Austin, Texas) last month was renamed On-X Life Technologies after Paul Capital Healthcare (New York) and several other existing investors provided $32 million through a combination of debt, revenue interest and royalty conversion, as well as a new equity capital infusion into the company.

The company, which develops the On-X heart valve, said it is now at a capitalization of $70 million.

“The benefit is that we can branch out with new projects,” Clyde Baker, president/CEO of On X Life, told Cardiovascular Device Update. “In the past the company was so burdened with debt we couldn’t [expand into other markets]. But now we’re looking forward.” The company said announcements of these other markets for expansion could come within the next three months.

The company is engrossed in an FDA-approved study that takes a close look at a group of low-risk aortic valve replacement patients and two low-dose warfarin groups of higher-risk aortic and mitral valve replacement patients. The study, Prospective Randomized On-X Clinical Trial (PROACT), was launched in June of 2006 and is expected to be completed by 2011. It is being conducted in 40 clinical sites comprised primarily of university-based medical institutions in the nation.

Results of the study won’t come any time soon. “We’re following these patients for five years,” Baker told CDU. “But we should receive some interim report in about 18 months. We’ll ultimately have 1,200 [patients enrolled.]”

The patient groups in the study include a non-warfarin group of low-risk aortic valve replacement patients and two low-dose warfarin groups of higher risk aortic and mitral valve replacement patients.

“Our expectation is that in these lower-risk aortic valve replacement patients you have the same or better morbid event rates than the other groups,” Baker said. The lower-risk groups will be those without heavier medication to regulate the blood flow into the valve and stop clotting.

Following the first implantations in 1996, recent clinical evidence suggests that patients implanted with the On-X valve may be able to forego or reduce the dosages of anticoagulation therapy traditionally required by mechanical heart valve recipients.

The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. On-X LTI also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices.

Shelhigh to cease distribution, will meet FDA production standards

In the latest round of a dispute between the FDA and Shelhigh (Union, New Jersey) — and perhaps the final round — the company last month agreed to stop distributing its implantable medical devices used in heart surgery and other procedures until it brings its production processes in line with FDA standards.

The agency noted that the agreement was made under a court order, but the comany had a different interpretation. It contended that it was not ordered by the court, but rather is a mutual no-fault settlement that the court agreed to sign so that the agency and the company could “resume good relations” and so that Shelhigh could resume delivering its “life-saving products.”

Regardless of the semantics, the U.S. District Court for the District of New Jersey entered the consent order of injunction agreed to by Shelhigh.

According to the FDA, the consent order forbids Shelhigh from distributing all devices until its manufacturing methods, facilities and controls are in compliance with the agency’s current good manufacturing practice (CGMP) and Quality Systems (QS) regulation for medical devices and the medical device reporting (MDR) requirements.

In April U.S. Marshals seized all finished devices and components of the devices at Shelhigh’s manufacturing facility due to concerns of potential risk of nonsterility.

Shelhigh makes pediatric heart valves and conduits (tube-like devices for blood flow), annuloplasty rings (to help repair heart valves) and arterial grafts, surgical patches and dural patches (to aid in tissue recovery after neurosurgery).

Douglas Goldman, a spokesman for Shelhigh, told Cardiovascular Device Update that the company and the FDA have been “hashing it out” ever since the agency quarantined its products in April. He said the company is “very happy” with the settlement it reached last week with the FDA.

“It’s completely a step in the right direction and I think it makes a lot of sense for both sides,” Goldman said. “There’s no sense in going through a trial if both sides want the same thing in the end and that is for the company to be able to continue producing its products.”

In May the agency issued to Shelhigh a formal written request to recall all of its medical devices from the marketplace, including hospital inventories, because of “sterility concerns.” In response, the company said at that time that it did not believe the FDA allegations were valid and that it had no intentions to initiate a recall.

In response to the settlement agreement, Goldman said that it is “important for people to know there was never a recall, either by the FDA or by Shelhigh, and the company continues to have confidence in the safety and efficacy of its products for their intended use.”

According to the FDA, Shelhigh may resume manufacturing, but not distributing, devices in phases, after the agency has approved its plan for bringing its seized products and manufacturing processes into compliance with FDA law. After Shelhigh has completed corrective actions and been allowed to resume manufacturing, the company must hire an independent auditor to inspect its facility at least once a year. Results of these audit inspections will be reported directly to FDA.

If Shelhigh fails to comply with any provision of the consent order, or violates FDA law or regulations, FDA said it may order the company to again cease manufacturing and distributing its devices, to recall the devices, and to take other actions deemed necessary by the agency, including payment of money for continuing violations.

Cordis resolves issues in FDA warning letter related to Cypher

Cordis (Miami Lakes, Florida) reported that the FDA has notified it that all items outlined in an April 2004 warning letter regarding its Cypher drug-eluting stent (DES) have been resolved.

The warning letter addressed what it called violations of the Federal Food, Drug and Cosmetic Act, noting that the agency was “concerned with the breadth and scope of the specific violations,” which the letter indicated were “symptomatic of the serious underlying problems in [the] firm’s manufacturing and quality systems.”

Cordis company spokesman Christopher Allman told CDU that the resolution of the FDA’s concerns outlined in the warning letter represented a “tremendous achievement” for those employees who had been devoted to ensuring that the company met agency requirements. “If you look at the warning letter itself... really the issues fall into the bucket that we would call processes and procedures,” Allman said.

Allman acknowledged that “a lot of internal resources” had been focused on resolving the warning letter. More importantly, the company could not proceed with next-generation products or apply for new indications for its Cypher stent.

The warning letter, which came as a result of agency inspections, outlined problems such as failure analysis reports relating to Cypher thrombosis complaints not having been “completed in a timely manner,” because the company failed to “establish and maintain adequate complaint handling procedures.” The agency specifically cited a complaint related to the Cypher stent involving a “thrombosis event” that was received on June 30, 2002 but was not closed until June 20, 2003.

“The FDA inspections found systemic violations in the quality management system employed to sure the safety and effectiveness of your drug-eluting stents that recurred at several of your facilities,” the agency said in its letter. The agency also cited “several hundred complaints” that were received in 2002 and 2003 through an Internet-based tracking system used by physicians to report complaints and adverse events that had not been “fully investigated at the time of the inspection.”

The sites cited in the letter were San German, Puerto Rico; Warren, New Jersey; Roden, the Netherlands; and Beerse, Belgium.

Despite the warning letter, Cordis was able to get approval for its treatment for clearing clogged neck arteries, a leading cause of stroke, in September. Johnson & Johnson (New Brunswick, New Jersey) reported at the time that its Cordis Endovascular (Warren, New Jersey) unit received approval for its Precise carotid stent and Angioguard system following receipt of an approvable letter in August 2004 after receiving an okay from the Circulatory System Devices Panel of the Center for Devices and Radiological Health in April 2004.

Bear Stearns analyst Rick Wise said, “Longer-term, resolution of Cordis’ warning letter may not be positive for competitors” such as Boston Scientific (Natick, Massachusetts), Abbott (Abbott Park, Illinois); and Medtronic (Minneapolis). Still, he cited the lack of a “visible near term JNJ pipeline and CoStar delays” as indications that the “DES competitive outlook is unchanged for the next 3-5 years.” According to Wise, it had not been anticipated that the warning letter would hold up “the expected [nine] Cordis product launches in 2007,” which includes balloons and guidewires.

Cambridge Heart tweaks pact with St. Jude for HearTwave II MTWA

Cambridge Heart (Bedford, Massachusetts) said it has amended its sales and marketing agreement with St. Jude Medical (St. Paul, Minnesota). St. Jude Medical’s sales force now will be able to market Cambridge Heart’s HearTwave II Microvolt T-Wave Alternans (MTWA) test to North American primary care and internal medicine physicians.

In addition, Cambridge Heart’s sales force now will have the ability to support St. Jude’s field sales force in all physician markets in North America. Under the original agreement, signed in March, the cardiology and electrophysiology markets were to be targeted by St. Jude’s field force, and Cambridge Heart’s representatives addressed the internal medicine and primary care markets.

“The amendment reflects the growing synergistic partnership between our two field sales forces and highlights the benefits of employing a strategic joint approach. Many patients at high risk for sudden cardiac death are in the care of internal medicine and primary care physicians, and the importance of addressing this population has been recognized increasingly by the CRM industry,” said Robert Khederian, interim CEO and chairman of Cambridge Heart.

Apart from expanding the markets in which Cambridge Heart and St. Jude may work together, the amended agreement retains substantially the same material terms as the original agreement, as outlined in the Form 8-K that Cambridge Heart filed with the Securities and Exchange Commission on March 27.

Cambridge Heart’s MTWA test measures a specific and extremely subtle pattern of beat-to-beat fluctuations in a person’s electrocardiogram, the company said.

This pattern of fluctuations is called T-wave Alternans. These tiny variations in the electrocardiogram, measured at one millionth of a volt accuracy, are measured most commonly during a sub-maximal exercise stress test in the physician’s office or hospital outpatient setting.

Endovasc creates BioFlow unit to develop biodegradable stents

Endovasc (Montgomery, Texas) reported the creation of BioFlow as a new, wholly owned subsidiary, to manage the continued development of biodegradable stents.

Endovasc and Nathan Blumberg, MD, have jointly transferred the intellectual property from both of the previous joint ventures involving TissueGen (Arlington, Texas) into BioFlow.

Diane Dottavio, PhD, president/CEO of Endovasc, told Cardiovascular Device Update that the first project of BioFlow would be to develop a biodegradable urinary stent for ureteral application. Dottavio said that urinary stents are currently made of rubber or silicone and are not biodegradable. After a procedure such as ureteroscopies (procedures to visualize the ureter and extract stones) and lithotripsies (external ultrasonic destruction of stones), a stent is often placed in the urinary tract to prevent the small stone fragments from coalescing and obstructing the ureter after the procedure.

“Once the fragments are gone they have to remove the stent, which is a second whole procedure, it’s painful, and it produces a cost to the patient that we think we can eliminate,” Dottavio said.

The company said that Blumberg would continue to contribute his expertise to develop and ultimately commercialize new biodegradable stents for ureteral applications. A unique product design conceived by Blumberg will be incorporated into the device, the company added.

BioFlow will manage product definition and the development process through a sponsored laboratory research agreement. The objective is to develop biodegradable ureteral and urethral stents that can be degraded in the body within seven to 14 days after a procedure, Dottavio said, compared to other biodegradable stents on the market which degrade in more like six weeks, she added. All IP developed under this research agreement is assigned to BioFlow.

Endovasc is focused on developing drug candidates in the areas of cardiovascular and metabolic medicine.

Scripps awarded $30 million gift for $430 million cardio center

Scripps Health (La Jolla, California) reported receiving a $30 million grant from The Howard Charitable Foundation to jump-start its plan to build a $430 million cardiovascular institute, which it says could become the largest heart program in California. The $30 million gift is one of the single largest philanthropic donations in the organization’s 83-year history, Scripps said.

Chris Van Gorder, president/CEO of Scripps Health, said that the gift “will allow patients to have greater access to many of the nation’s top cardiac experts and lifesaving services at Scripps.”

The cardiovascular institute, slated for completion in 2015, will be built on the campus of Scripps Memorial Hospital La Jolla. It will include 168 in-patient beds, cardiac catheterization labs with advanced medical technology, centralized cardiovascular research labs and a center for graduate medical education for physicians, Scripps said.

Scripps says that it is the largest provider of cardiac care in San Diego with more than 45,000 cardiovascular discharges in 2005.