Cardiovascular Device Update Washington Editor
And CDUs

According to the American Heart Association (Dallas), 57,000 people in the United States die every year from congestive heart failure (CHF), but only slightly more than 2,000 hearts are available annually for transplant. Serving as a potential lifeline to the 55,000 on the waiting lists are ventricular assist devices (VADs) used for bridge to transplant (BTT) — though their use does not solve the problem of the donor shortage — and artificial hearts — though there is only one such product available (as of this issue of Cardiovascular Device Update) and still not solving the donor shortage problem. Alternatives include the use of VADs and similar devices to rest the heart and allow it to recover. And farther out will be the broad development of VADs and artificial hearts as destination therapy, after there is no hope for transplant but extending life for a number of months and, hopefully, years. But these alternatives are far from finding broad clinical use.

After a wave of activity in the early part of this decade, the pace of development in this sector appears to have slowed over the past year while the cardiovascular device space as a whole appears to be putting its developmental energies into stents and advanced pacing technologies.

Clearly, the device sector targeting the failing heart needs to get pumped up since the patient pool in this market is so sizable — and growing. The demographic bulge in most developed nations is making its way into its “golden” years and cannot help but feed increased demand. And even those who survive mid-state heart disease with the use of open heart surgery, angioplasty/stenting or ablation, face the ultimate, end-stage forms of heart failure.

Of the two primary mechanisms for dealing with CHF, the artificial heart has drawn the widest, headline-grabbing attention, with VADs coming along as a comparative novelty but offering even broader avenues for treatment before CHF end-stages.

The artificial heart is, of course designed to deal with failure of both ventricles while the VAD is typically designed to offer only left ventricle failure support. Both classes of devices share difficult, long-standing problems, including damage to blood cells and the risk of clotting and stroke (seven of 14 patient’s in the trial of the AbioiCor artificial heart from Abiomed [Danvers, Massachusetts], reportedly died of stroke.)

AbioCor fully implantable

Abiomed, driven by the inspirational vision and energy of its founder David Lederman, MD, has had the highest profile and produced the largest headlines in the artificial heart race with its AbioCor Artificial Heart. The AbioCor is fully implanted within the body and requires no interaction for at least part of a patient’s day.

The components of the Abiocor system consist of a pump, a rechargeable lithium battery, a pump controller, and a battery recharge unit that uses an electroconductive coil to draw charge from an external electromagnetic field. For the most part, the external charging unit must always be present because the Abiocor’s internal battery can operate the pump for only 20 to 30 minutes. The pump can handle 100,000 cycles per day and weighs about two pounds. The device has a life expectancy of about a year-and-a-half and costs more than $250,000.

In 2001 the company launched a clinical trial of the AbioCor with the goal of implanting 15 patients. The first patient, Robert Tools, was implanted in July of 2001 and was supported for about 150 days before he died.

And 13 more patients were implanted with the AbiCor, the last in May of 2003, the device providing that patient 165 days of survival.

Though Abiomed never enrolled the 15th patient in the trial, it won an FDA humanitarian device exemption (HDE) for the AbioCor in September of 2006, allowing implantation in 4,000 patients — this, despite failing the previous year to persuade the agency’s circulatory systems devices panel to recommend approval — and the device is still in play under the HDE.

At the time of the HDE approval, Michael Minogue, president/CEO and chairman, said that further implantations would come only with careful roll-out and that the company would “go back and train and retrain the centers signed up” to perform the implantation since there had been a two-year hiatus in the procedures.

Minogue said that retraining process would take from six to eight months, beginning with three to five centers and then expanding in phases to what he set as 10 centers as “a maximum.” But, more than 11 months later there have been no implants.

Waiting for okay of ‘supplements’

The company says that the delay has been the result of the filing of supplements with the FDA concerning its protocols, primarily for improvements in the reliability of batteries and software.

The company most recently said that the first of the implants under the HDE will likely come either in late summer or early fall. And Minogue, during the company’s 4th quarter conference call, said that the first patient implant “is likely going to be done at Jewish Hospital,” the Philadelphia hospital that performed the majority of implants in the company’s human trial.

The delay is also understandable given what Abiomed has learned in its clinical trial: that the patient most likely to benefit has to be carefully selected — and fairly unique. This is a patient with serious end-stage heart failure but without an overwhelming number of serious co-morbidities that indicate poor prognosis for added months of life.

During the 4Q call, Minogue said, “It is more important for us to have the right patient selection and the right patient management so that all of these [implanted] patients go home.”

In development: AbioCor II

Hopefully, these implants soon will proceed. But in the meantime, the company and the implanting centers are looking forward to development of the second-generation AbioCor — one reason, perhaps, for not pushing aggressively forward with the first-generation AbioCor.

“The Abiocor II is currently in animal studies as well as reliability studies, and we’ll decide in the future if it becomes its own PMA path,” Minogue told CDU.

Abiocor II will be about 30% smaller than the original, and Abiomed says it will be supporting its claim to the FDA with data indicating that the device will be able to function inside the human body for five years. Because of the smaller size, the Abiocor II would be useful for nearly all American men and as many as half of all American women, according to the company.

This latter point is not a small one since the 14 patients implanted with the AbioCor were all men, since most women’s bodies are not large enough for the device, about the size of a grapefruit.

Alexander Arrow, MD, a director at Lazard Capital Markets (New York) whose focus is on therapeutic medical technology, told CDU that while Abiomed has invested 17 years in its pursuit of the artificial heart, the $250,000 price tag of the device creates significant barrier to sales (and the company has never released information concerning the financial costs of implantation and follow-up care in its clinical trial). Arrow said, however, that even though the DRG 103 reimbursement code pays only about $130,000, it also includes modifiers that would round the figure up to $200,000, perhaps the single highest DRG ever approved.

Some hospitals might be willing to absorb that difference so as to promote themselves as premier centers for heart disease (and likely the primary incentive for the hospitals that participated in the company’s trial).

“Our total unit projections [for implants of the AbioCor II] three years from now would be 38 units,” Arrow said. “It is a fairly specialized population because you have to have bilateral [heart] failure.” He noted that Abiomed has “enough of a base business to keep things going” with its other lines of products for at least another nine or 10 quarters and that the company may need as long as two years to coax an HDE from FDA for the Abiocor II.

Abiomed shifts its focus

But Abiomed clearly shifted its emphasis away from AbioCor development, following the exit of David Lederman as company president in 2004. When Minogue took over company leadership, he quickly developed a corporate mantra that Abiomed prefers that patients return to their homes “with their own natural hearts” and he began building a broadened line of heart support devices, primarily the development of the AB5000 Ventricle, an external VAD, and its line of Impella pumps, acquired with the purchase of Impella CardioSystems (Aachen, Germany) in 2005 — thus emphasizing delivery on sales rather than R&D and R&D potential.

The Impella devices — described as micro blood pumps with integrated motors and sensors — are implanted percutaneously for short-term boost to the function of either or both ventricles. The Impella 2.5, which can deliver up to 2.5 liters of blood per minute, is 4 mm in diameter and the small surface area reduces the volume of anticoagulant needed to keep the device from clogging up. The pump unit resides in the aorta and draws blood from the left ventricle via a tube. The Impella Mobile Console facilitates patient transport in-house and to other hospitals for additional care.

Abiomed has won the CE mark for the Impella circulatory support systems, and in mid-July it reported receiving Health Canada approval for sales of the Impella 2.5 and 5.0 blood pumps.

Importantly, the company recently completed enrollment in its pilot study of the Impella 2.5 and has submitted to the FDA a 510(k) appliction, “while also pursing the PMA path,” according to Minogue.

One of the major upsides for the Impella is that because it works from within the heart, an interventionist can install it percutaneously, a sizeable advantage in terms of cost. A limitation of the 2.5 device is that it can remain inside the human body for only up to five days and is hence limited to critical care situations while the patient and doctor ponder their next move.

The limited pumping ability reduces the device’s use to those whose left ventricle is still somewhat functional. For those whose left ventricles are not meaningfully functional, the Impella 5 can pump up to 5.5 liters of blood per minute, and can remain in the patient for up to 10 days. Virtually identical to the 2.5 except for size, the 5.5 is also installed percutaneously.

The Impella 2.5 is “absolutely” Abiomed’s flagship product, Minogue told CDU. And the company plans to apply for both a 510(k) and a PMA for the product, with the latter application motivated by the potential for making a claim of clinical superiority.

Reaching for profitability

Currently these systems are the focus of the company’s attempt to reach profitability. Abiomed lost more than $27.8 million in FY07, down from a $29.4 million net loss the previous fiscal year. Sales and administrative expenses rose sharply in FY07, hitting $42.4 million from $30.9 million in FY06. In May, Abiomed reported that FY07 revenues rose 16% to $51 million over FY06 revenues, which rang in at $43.6 million. The company projected that its FY08 revenues will grow more than 20%. Revenue from its AB5000 line of VADs jumped 38% for fiscal 2007 while revenues from the BVS 5000 declined 22%. Revenue from the Impella series of VADs was up 87%.

In March, Abiomed reported that it would release 5 million shares of common stock at about $13.75 a share with the expectation that it would net a bit more than $63 million on the NASDAQ board. And underwriters picked up roughly 80,000 of 750,000 additional shares to net the company roughly $64.6 million from the sale.

A product via patent donation

Like Abiomed’s AbioCor heart, the CardioWest Temporary Artificial Heart (TAH-t) from Syncardia Systems (Tucson, Arizona), the very first artificial heart approved by the FDA in 2004, is also in a kind of in-between situation since the large, long-term opportunity is more likely to come from development of advanced forms of the TAH-t.

The CardioWest TAH-t can claim the original Jarvik Heart as its famous ancestor. Long forgotten about the history of that first Jarvik Heart — initially implanted in retired dentist Barney Clark in 1982 — is that it was based on a design patented in 1963 by amateur inventor Paul Winchell. Winchell was better known for his work as a voice actor, especially for providing the voice of that hyperactive tiger, Tigger, in productions of the A.E. Milne’s Winnie the Pooh.

Winchell (who died of unspecified natural causes in 2005 at the age of 82) donated his patent for the artificial heart to the University of Utah (Salt Lake City), where Robert Jarvik, MD, reshaped it into the Jarvik Heart. And in a small historical irony, Dr. Jarvik is now best known as TV spokesman for Lipitor, a best-selling heart drug.

The initial use of the Jarvik implanted in Clark received worldwide microscopic publicity — perhaps over-much — in chronicling Clark’s final painful weeks and days of life, and so may have served to retard development of this technology. But however slow, this development pathway led to Syncardia’s Jarvik-7 temporary artificial heart, the CardioWest TAH-T.

To gain approval, SynCardia won a positive panel recommendation in March of 2004 and received final PMA approval in October 2004. SynCardia says that the CardioWest is still the only artificial heart for BTT application that bears both a CE mark and a premarket approval from FDA.

Significantly, the CardioWest is not fully implanted. The implanted portions are tethered to a pneumatic pump system that is so large and heavy that it requires four casters to roll about on a floor, and those systems have been in short supply. According to Don Isaacs, as of late July, 662 CardioWest hearts have been implanted.

Portability waiting in the FDA wings

The next-generation version of the heart developed by SynCardia is focusing on greater mobility. The company has developed a portable pneumatic motor that allows the wearer to get up and move about. This more portable system, the Companion Discharge Caddy, in width and height is a bit larger than a briefcase and is carried on a two-wheel cart. It became available in Europe in July 2006. The caddy is not yet available in the U.S., but Syncardia reports that it is currently assembling a clinical trial to support an FDA nod and has said it will be enrolling patients for the trial later this year.

SynCardia is also working on development of a smaller version of the TAH-t, one that has a 50 cc pump and will serve a wider range of patients than can use the 70 cc pump.

The company unveiled the new program at the third annual meeting of the AHA in June, and according to an accompanying press statement, it plans to have the 50 cc TAH-t “in development by 2009.”

There is no surprise in the fact that reimbursement for these devices is a key problem, given the significant technical barriers facing the sector. The Centers for Medicare and Medicaid Services does not cover artificial hearts at this time, but did carve out a new category in its diagnostic-related group, DRG 103, three years ago, serving as a slot for artificial hearts once the agency is convinced of necessity and appropriateness. Despite the lack of real reimbursement action at CMS, at least one contractor, Blue Cross of California (Woodland Hills, California), has issued a local coverage decision of “medically necessary” for the TAH-t.

In May 2004, SynCardia reported that its Series B financing consisted of $3.7 million, but the firm has yet to recruit for a Series C financing. The company has given no indications that it plans to go public.

VADs on the move

While there have been various changes and altered iterations of VAD technology, the mission is still the same: to deliver oxygenated blood from the left ventricle and pump it up to the aorta for transport into the body.

The clear leader in the VAD sector is Thoratec (Pleasanton, California), developer of the HeartMate VAD devices which won a variety of FDA approvals earlier this decade. The HeartMate Left VAD (LVAD) is implanted alongside the natural heart and takes over the pumping function of the left ventricle for patients whose hearts are too damaged or diseased to produce adequate blood flow.

The company most recently has put its focus on advancing development of its HeartMate II, and won CE marking for that version of the device in November 2005. But it has yet to win FDA approval and has been negotiating some turbulent waters over the past year.

Early in the year, it faced potential de-listing by NASDAQ as a consequence of tardiness in filing its reports with the Securities and Exchange Commission. But the company averted further problems when it filed an amended report on equity-based compensation practices within the 15-day SEC window.

Thoratec has also had to deal with a pair of recalls.

In April it initiated a recall of one for its Paracorporeal VADs, the result of using incorrectly sized devices (a collet and collet nut) used to fix the cannula to the pump. This led to numerous cases of bleeding and was blamed for three deaths. The recall required only that the collet and nut be replaced on the almost 2,500 units that were manufactured before Oct. 26, 2006. As of late July, the company said the recall was 92% complete.

A bigger difficulty came in June when the company reported a recall of 378 units of its TLC-II portable VAD drivers due to premature motor failure. As of mid July, the company had received notice of 21 such malfunctions, and the recommended service interval for the driver has been dropped from every 3,000 hours to every 1,500 hours as a result.

Lazard Capital Markets (New York) issued a report in July saying that the two recalls are not expected to materially affect the firm’s financial standing and “the real driver of [Thoratec’s] stock will continue to be” the HeartMate II. But Lazard projected that “FDA issues” will push back the approval of the HeartMate II from 3Q07 to 1Q08. It based that view to some degree on what it said were discussions with a former member of the circulatory systems advisory committee, who advised Lazard that Thoratec is likely to need another trip to the advisory committee. Still, that source, unnamed, expected a positive outcome.

Lazard’s Arrow told CDU that Thoratec is not totally dependent on the HeartMate II for its long-term viability. He noted that though two-thirds of the company’s revenue comes from sales of other VADS and its diagnostic products, the HeartMate II is “the most talked-about” part of its product inventory.

The company is a provider of point-of-care testing instruments and disposables through its wholly-owned subsidiary, International Technidyne Corporation (ITC; Edison, New Jersey). Arrow told CDU that Thoratec’s ITC business “is the most operationally profitable, but he said it lacks the growth opportunities” of the VADs.

Thoratec can sustain itself on sales of its Implantable VAD and the PortableVAD, Arrow said, though he billed them as not “enormously profitable.” And in the meantime the HeartMate II is the product supporting the company’s stock value.

Arrow described the HeartMate II as “a big improvement over the HeartMate XVE” — the company’s VAD approved for a DT application — said it and said it will sell better than the XVE. HeartMate II will do well, but “not as well as others would have it,” Arrow said. And that is the rationale behind the forecast for Thoratec stocks, which Arrow rated as a sell at $20.25 per share and sees a target price of $15.

Data positives for HeartMate II

In attempt to win faster FDA approval for the HeartMate II, Thoratec is conducting the BTT and DT studies concurrently in an effort to accelerate the regulatory process.

In May the company completed enrollment in the randomized portion of the DT arm of its pivotal trial for the HeartMate II by enrolling 200 patients on a randomized basis as called for in the trial protocol.

And earlier in May it received FDA approval for a Continued Access Protocol (CAP) to enroll an additional 60 patients in the DT arm. The company also recently received a CAP to enroll an additional 60 patients in the Bridge-to-Transplantation (BTT) arm of the trial. The CAP patients in both arms will be enrolled and followed under the original protocols of their respective clinical trials.

Gary Burbach, president/CEO of Thoratec, said, “With the completion of the DT arm, and the BTT arm last year, we believe this represents the fastest enrolling trial in the history of VAD technology.”.

The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients.

Thoratec in late March published interim data from the pivotal trial for the HeartMate II for the BTT arm. In a presentation at the 2007 American College of Cardiology (Washington) scientific sessions in March, Leslie Miller, MD, of the Washington Hospital Medical Center (Washington), reported that 75% of the patients in this arm had received a transplant or had survived 180 days without losing transplant eligibility. One patient is reported to have lived 600 days.

The level of adverse events “in major categories was lower than that reported in previous trials with pulsatile devices,” according to a company statement, with no pocket infections reported and only 18 infections of the device’s leads. This represents a drop of 90% over the HeartMate BE. Other categories of adverse events that improved with the HeartMate II included a 40% drop in the incidence of bleeding requiring follow up surgery and a cut in half of the rate of stroke. Non-stroke neurological events declined by about 60%.

Miller said that the outcomes of this study “demonstrate that the HeartMate II not only provides reliable, long-term circulatory support, but also improves the quality of life for these patients.”

Worldheart focuses on Levacor

Worldheart (Oakland, California) also has carved out a place in the VAD business, principally via the Novacor LVAS (left ventricular assist system), commercially available in Europe, Canada and Japan, and approved for BTT use in the U.S. in 1998. Worldheart acquired the Novacor LVAS in 2000 via purchase of the Novacor system from Edwards Lifesciences (Irvine, California).

Like many second-line companies in the device sector, WorldHeart has faced structural difficulties. Its independent auditors in April issued a “going concern” statement in its annual report. And in the fourth quarter of 2006 it restructured operations to reduce expenses, it said, to realign resources for focus on its next-generation opportunities.

At the time, Jal Jassawalla, president/CEO said that the company would continue to put its energies “on the final development, evaluation, regulatory approval and commercialization of our next-generation Levacor Rotary VAD.” “We expect to initiate clinical use of the Levacor Rotary VAD in Canada in the near-term and start a U.S. feasibility trial in the latter half of 2007.”

The Novacor uses a solenoid to electromagnetically attract two levers, each of which presses on the outside of the disk-shaped pump unit. When current hits the solenoid, the levers close and pump the blood from the unit to the aorta. When the solenoid loses current, the levers fall open, allowing blood to flow in from the ventricle.

The Novacor II LVAS operates on largely the same principal but uses only one lever to compress one side of the disk-shaped pump chamber, allowing the more rigid other side to serve as a source of resistance.

The device first went into an animal model in 2005, and the company began feasibility trials for the Levacor in 2006. In June 2007 the company reported the first explant of a Levacor patient, age 67, saying that after 85 days of support with the device, his heart regained function and he was enjoying “excellent quality of life.”

Worldheart joins other companies in targeting potential use in children. In mid-July it reported implantation of a VAD for pediatric use (from birth to 24 months) in an animal model using the same magnetic levitation unit found in the Levacor. The unit is designed to provide a flow rate of between 0.3 to 1.5 liters per minute.

Australian firms in the mix

Ventracor (Sydney, Australia) targets the VAD space with its VentrAssist system, which the company describes as a “new third-generation cardiac assist system primarily designed as a permanent alternative to heart transplants for patients suffering heart failure.”

This LVAD employs a rotary pump equipped with a hydrodynamically suspended impeller. It weighs 10 oz. and is roughly 2.5 inches in diameter, making it small enough to implant in children.

Ventracor has received FDA approval for a trial for the VentrAssist that would cover DT with two arms. One arm will randomize 180 patients at a ratio of 2:1 into the VentrAssist or drug therapy, respectively; the second arm will randomize 45 patients at the same ratio with an unnamed competitor VAD serving as the control therapy.

The DT trial design is purportedly itself the subject of a patent application, and a February statement by Ventracor said that the trial had “the potential to reduce time to market by up to 18 months.

As for its BTT trial, Ventracor reported that this would run concurrently with the DT trial and would use a success criterion of 75% (+/- 10%) of patients that either received a transplant or have survived and are still eligible for a transplant at 180 days. In April, the firm announced that the 100th patient had received the VentrAssist.

Ventracor in May reported “a successful share placement of about $21.5 million” of company stock, which trades on the Australian Stock Exchange. According to CEO Peter Crosby, “the new capital will allow us to take full advantage of the opportunity for more rapid progress toward U.S. regulatory approval” of the VentrAssist and to bring other products along. On June 26, the company pulled in another $28.4 million from the issuance of a share purchase plan and a private placement, which followed by 20 days the announcement that the BTT trial had enrolled its first patient in the U.S.

An Australian competitor is HeartWare (Sydney), developer of the HVAD Left Ventricular Assist Device (HVAD). With a volume of 45cc, the HVADT device is the smallest “3rd generation” pump and the only full output device implantable routinely within the thoracic cavity, according to the company, its small size enabling minimally invasive implantation.

The company in July reported that in its clinical trial, implants had been made in 16 patients at three Sydney hospitals, accumulating 2,400 days of support, an average of 150 days per patient. It reported 15 of 16 patients “alive and well,” with all but the three discharged from hospital. Seven successfully passed the trial’s primary endpoint of survival to 180 days or to the point of undergoing heart transplantation. Three patients received heart transplants, after being supported by their pumps for 427, 348 and 157 days respectively.

HeartWare has said it would complete its 20-patient enrollment in the trial “over coming weeks.”

The company reported pre-clinical studies under way for its MVAD device, one-third the size of its HVAD device. And it ssaid that its IV-VAD, one-10th the size of the HVAD, at “early prototype stage.”

Berlin Heart makes pediatric inroads

Berlin Heart (Berlin, Germany) has developed several VAD offerings, including the Incor, an implantable LVAD that uses an Archimedean screw assembly mounted on a “free floating, active magnetic bearing.”

The hope is that this design will allow the device to avoid wear and hence be used “on a permanent basis.” The device is said to be 30 mm in length (or slightly more than one inch) and operates at between 5,000 and 10,000 revolutions per minute. The system includes an on-board battery for short-term use and a controller unit.

The company’s Excor system operates outside the body with tethering only necesssary to conduct blood inside the body.

The company is perhaps best known for its development of VAD devices for pediatric use, thus far provided under compassionate use exemptions from the FDA in the U.S. While none of its products is approved in the U.S., in May it received FDA approval of an investigational device exemption for implantation of its EXCOR Pediatric VAD at 10 U.S. centers in 10 pediatric patients suffering severe heart failure.

EXCOR Pediatric, designed for BTT application, has been used as a medium- to long-term support system, supporting failing hearts for up to several months. It said the device also has worked as bridge to recovery. The EXCOR Pediatric is a pulsatile, pneumatically driven VAD and can be used to support one or both ventricles.

Micromed can boast big names

Micromed (Houston) is the developer of the MicroMed DeBakey VAD and can boast an association with various prestigious participants in its R&D development. The device is a joint project of the National Aeronautics and Space Administration, the Baylor College of Medicine (both Houston) and Dr. Michael DeBakey and his colleague Dr. George Noon. The VAD has just one moving part, is the size of a “C” battery and weighs less than 4 ounces.

The company last year received an extension to April 2011 of its CE mark for its VAD, granted by notifying body TUV. In May it reported the successful explant of its device from the first patient, a 36-year-old woman, implanted and recovered. The patient had suffered from post partum cardiomyopathy and Class IV end-stage heart failure with an initial left ventricle ejection fraction of 12%. She was supported for 483 days by the DeBakey VAD.

Later in May the company reported the first implant of its latest generation DeBakey VAD X2 pump in a 59-year-old man in the UK. The patient was suffering from severe ischemic cardiomyopathy and was “doing well.”

Non-pump approaches to cardiac assistance

While VADs thus far have the lion’s share of late-stage device assistance for the failing heart, the sector also offers other device therapies.

One of the more outside-the-box approaches to ventricular assist is offered by Acorn Cardiovascular (St. Paul, Minnesota) with its CorCap cardiac assist device. The CorCap is made of polyethylene terepthaliate in a mesh designed to contain the expansion of the heart that is characteristic of CHF, with the goal of keeping the heart going and helping it to remodel. The CorCap has been available in Europe since 2000 and, as of May, had been implanted in 465 patients around the globe.

Acorn has run up against regulatory barriers in the U.S., however. In June 2005 the circulatory systems advisory panel of the FDA rejected recommending approval of the CorCap by a vote of 9-4, and the agency issued a non-approval letter to the company in August 2005.

The company succeeded in gaining a hearing before the agency’s dispute resolution panel in December of 2006, but that hearing resulted in another turndown. The rejection is not a death knell for the CorCap, however.

The dispute panel recommended that the company boost enrollment of its clinical trial from the original 170 patients to 300 and to extend the follow-up from six to 12 months.

The new trial will enroll only 50 additional patients, and Acorn has said it hopes to complete enrollment early in 2008 and win FDA approval no later than early the following year.

In May, Acorn President/CEO Rich Lunsford told CDU’s sister publication, Medical Device Daily, that the company would need about $15 million in additional funds to fund the trial and to keep operations going, but that additional funding has not developed as of yet.

Biophan (Pittsford, New York), has taken a similar alternative tack toward heart failure with its Myotech circulatory support system, a flexible polymer cup that is positioned around the heart and uses pneumatic pressure to boost the heart’s ability to pump blood.

Because the heart is radially asymmetric, the pressure applied by the inflatable cup does not interfere with the normal beat progression, from the left ventricle to right.

The device also has the advantage of requiring only a small incision into the thorax for installation and no incisions into the heart.

However, there is no indication at either the company’s web site or at that the device is in clinical trials.