A CDU

Can a minimally invasive approach and a quicker patient recovery time following transmyocardial revascularization (TMR) via robotic assistance override some surgeons' ambivalence about the procedure?

That ambivalence is the hump that CardioGenesis (Irvine, California) is attempting to cross, with upcoming roll-out of its PEARL (Port Enabled Angina Relief using Laser) 5.0 Robotic Delivery System.

"PEARL is the first minimally invasive TMR that uses robotic assistance," Richard Lanigan, president of CardioGenesis told Cardiovascular Device Update.

The company completed a 40-patient IED study for PEARL in February, and it received pre-market application approval for the device earlier this month. It intends launch of the device during the annual meeting of the Society of Thoracic Surgeons (Chicago) in January.

Typically TMR procedures are used for patients suffering from angina or chest pains, but the history of TMR has been dogged by suspicions that it is no better than placebo and requires too much effort for debatable results.

CardioGenesis has continued to promote the procedure as worthwhile and now, with robotic aid, says it will be even more beneficial.

In TMR, a surgeon makes an incision on the left breast to expose the heart. Then, using a laser, a series of holes are punched into the heart's pumping chamber to provide more channels for perfusion of blood.

From 20 to 40 1 mm laser channels are placed during the procedure. Bleeding from the laser channels on the outside of the heart stops after a few minutes of pressure from the surgeon's finger.

This is how PEARL works:

The PEARL Robotic delivery system consists of the CrystalFlex fiber optic within a hand piece with an extended-length flexible shaft enabling it to be introduced through small incisions in the chest wall through a 5 mm port. The end of the flexible shaft is designed to enable the grasping and manipulation of the tip by surgical robotic tools within the chest cavity for placement on the surface of the targeted area of the heart muscle. The CrystalFlex fiber optic is then advanced through the flexible shaft into the heart muscle using the hand piece control to create a series of laser channels.

The system is designed for operation through a 5.0 mm port by the da Vinci surgical robotic system from Intuitive Surgical (Sunnyvale, California).

"The Cardiogenesis TMR system uses laser energy delivered through a small optical fiber to create channels in heart muscle that doesn't have enough blood supply, thus helping patients with disabling chest pain or angina," said Louis Brunsting III, MD, of Centennial Medical Center (Nashville, Tennessee), principal investigator for the PEARL investigational device exemption clinical study.

"The PEARL 5.0 device now allows this form of treatment to be performed entirely endoscopically, with only a few port incisions. This new minimally invasive approach, utilizing a surgical robotic system, can markedly reduce hospitalization and recovery time for patients, facilitating their return to an active lifestyle."

That recovery time is four days compared to the six to eight days it would take for a thoractomy incision to be made.

But will surgeons flock to PEARL?

"There are different challenges for robotic systems," Lanigen said. "One of the issues is adhesions that remain from patients who have already had bypass surgery." He makes no bones about the device facing some roadblocks, but he says that ultimately it will fill an important technology niche.

VIVID study in 'frontier' of percutaneous valve repair

Percutaneous valve repair has been touted as the bold new frontier for surgeons and med-tech companies. The "frontier" adds an assortment of treatment options available to those who suffer from coronary artery disease.

Med-tech start-up Myocor (Maple Grove, Minnesota) already has reported its intentions to embark on the path, with the recent news of the FDA granting conditional approval of the company's Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) feasibility study.

The single-arm study is poised to evaluate the safety and feasibility of the percutaneously implanted iCoapsys system in treating patients with mitral valve insuffiency (leaky valve) caused by left ventricular dysfunction and coronary artery disease (CAD).

"We're looking at maybe having 15 to 30 patients with up to six centers," Myocor CEO Jim Hickey told CDU. "The study should be completed by 2008." Hickey was named CEO of Myocor nearly two years ago.

The iCoapsys device and implant procedure are based on the original, surgically implanted Coapsys system. The first Coapsys device is currently being evaluated in the RESTOR-MV trial. Both devices are designed to reduce functional mitral regurgitation and reshape the left ventricle to provide a more complete reshaping therapy than traditional mitral valve repair. The development of the iCoapsys system will allow Myocor to provide physicians with percutaneous options for their patients, while Coapsys allows for surgical options.

Both devices have two pads with a long cord and resemble a T. Here's how they work:

The device is implanted so the two pads are located on the surface of the heart with the chord passing across the left ventricle. The posterior pad of each device has a superior (top) and inferior (bottom) head. During the implant procedure, the pads are pulled towards each other to decrease the distance between the mitral valve leaflets and reshape the left ventricle. The Coapsys and iCoapsys devices are designed to provide the same Reshaping therapy via different delivery approaches.

"The total procedure should take about an hour," Hickey said.

'Percutaneous valve repair is a new frontier of patient care," said Wes Pedersen, MD, interventional director, complex valve disorders, at the Minneapolis Heart Institute. "The iCoapsys system offers patients an innovative, less invasive option for treating their functional mitral regurgitation. It is very exciting to be able to participate in the VIVID feasibility study as the principal investigator at Abbott Northwestern Hospital."

To date, valve repair operations have offered new opportunities to patients and med-tech companies have been in a rush to put their special mark on them.

CoreValve (Irvine, California), Edward Life Sciences (Irvine, California) and JenaValve (Munich Germany) have all been reported as major players in aortic valve replacement procedures.

The procedure was ranked No. 2 in the second edition of the Top Ten list of medical innovations for the year, which was presented on the final day of the Cleveland Clinic-sponsored Medical Device Innovation Summit in early October.

With all the attention valve procedures are receiving, this is a perfect time to transverse this market.

"We have been very disciplined in bringing these devices through the design, manufacturing and trial processes with an eye on long-term success," Hickey said. "We have been fortunate to have the experience of implanting over 120 Coapsys devices worldwide, the dedication of a talented group of employees and clinicians who believe in our therapy, and the backing of a strong investor group."

Myocor has been in existence since 1996 and is a privately held company financed through a number of venture capital firms, Hickey said. To date it has raised $50 million.

Abiomed loans $5 million to WorldHeart, signs 2-year alliance

In an effort to access a broader customer base, Abiomed (Danvers, Massachusetts) said on Dec. 12 that it would loan $5 million in convertible secured debt to WorldHeart (Oakland, California), with a term of two years and bearing interest at 8% per annum, as part of a strategic investment in the company.

Abiomed makes devices intended to provide circulatory support to acute heart failure patients and WorldHeart develops implantable mechanical circulatory support systems for chronic heart failure patients.

The loan is convertible, at Abiomed's option, into common shares of WorldHeart at a conversion price of about $1.75 a share, resulting in roughly a 19.9% ownership interest in WorldHeart upon conversion. The loan is secured by all of the assets of WorldHeart, including its intellectual property. Abiomed ended its most recent fiscal quarter with $59.5 million in cash and no debt.

The two companies also entered into a two-year marketing and clinical support services agreement to seek opportunities to leverage existing expertise and resources at Abiomed and potentially provide cost savings for WorldHeart.Abiomed will be issued a warrant for the purchase of up to 3.4 million common shares of WorldHeart. It also has been granted a right of first refusal to distribute WorldHeart's products, other than the Novacor LVAS product that is being sold by WorldHeart, the companies said.

Abiomed also has been granted the right to designate one nominee or observer to the WorldHeart board of directors.

Jal Jassawalla, president/CEO of WorldHeart, told conference call listeners that the company is "particularly pleased by the validation of our technology represented by this alliance."

WorldHeart is developing the Levacor Rotary Ventricular Assist Device (VAD), which is designed to provide support for chronic heart failure patients.

The Levacor is a bearingless, fully magnetically levitated implantable centrifugal rotary pump that suspends the spinning rotor, minimizing wear within the pump and allowing greater clearances around the rotor with more uniform flow patterns. The device is not FDA-approved.

Jassawalla said WorldHeart is not projecting timelines through to approval of Levacor but that it does expect to start a clinical trial in the first half of 2008. He said the company already has "a number of high-volume centers" lined up to participate in the study.

Abiomed and WorldHeart intend to explore technical synergies, such as the potential to use Abiomed's information and transcutaneous energy transfer (iTET) system with WorldHeart's Levacor product. Abiomed's iTET system consists of internal and external coils that are used to transmit power and information across the skin. Because tubes or wires do not pierce the skin, like other implantable LVADs, the chances of developing an infection are significantly decreased and patients have the freedom to shower and bathe without the need for protective dressing, the company noted.

Michael Minogue, president/CEO and chairman of Abiomed, told conference call listeners that science, clinical data, engineering and culture fit were the reasons the company wanted to invest in WorldHeart.

"The No. 1 reason is we truly believe that this is the best long-term implantable pump that will help grow the destination therapy market and we wanted to find the most reliable and best pump to match to our iTET as well," Minogue said.

WorldHeart said it continues to explore additional funding alternatives to support its longer-term operations and business.

Abiomed immediately funded $1 million of the loan and expects to fund the additional $4 million in early January.

If Abiomed chooses to convert the loan and exercise the warrant for 3.4 million shares, at 1 cent a share, this would total roughly 6.26 million common shares of WorldHeart. That would give Abiomed nearly 35% ownership interest in WorldHeart. Abiomed said its ability to exercise the warrant and convert the loan is limited to a maximum of about 2.29 million shares under the Nasdaq rules until WorldHeart shareholders have approved the transaction.

Abiomed said it does not intend to acquire ownership or control of additional securities of WorldHeart.

Class action filed in wake of lead recall by Medtronic

A class action lawsuit has been filed in the U.S. District Court for the District of Minnesota on behalf of all purchasers of securities of Medtronic (Minneapolis) from June 25, 2007 through Oct. 15, 2007, by the law firm Schiffrin Barroway Topaz & Kessler (Radnor, Pennsylvania), that suit related to the company's October recall of its Fidelis leads.The complaint charges Medtronic and certain officers and directors of the company with failure to disclose, and misrepresentation of, adverse events known to them or disregarded by them, including:

• that the company received "a substantial and increased number" of reports of death and serious injuries caused by fractures in its Sprint Fidelis defibrillator leads;
• that the company failed to suspend distribution of these defibrillator leads in the face of these mounting safety concerns;
• that as these safety concerns were revealed, Medtronic would be forced to suspend distribution of these defibrillator leads;
• that the FDA would consider this "removal action" to be a "medical device recall";
• that the recall would have a significant financial impact on the company in subsequent quarters;
• that the company lacked adequate internal and financial controls;
• and that due to the recall the company's statements about its financial well-being and business prospects, when made, lacked a reasonable basis.

On Oct. 15, Medtronic disclosed that it had received a number of adverse reports about its Sprint Fidelis defibrillator leads, attributable to manufacturing defects, these reports identifying significant safety concerns. The company acknowledged that it had identified hundreds of malfunctions, serious injuries, and five patient deaths where a Sprint Fidelis lead fracture "may have been a possible or likely contributing factor."

Medtronic also reported that it had stopped distribution of the Sprint Fidelis leads and instructed physicians to stop implanting the leads and return all unused products. The FDA then issued a notice saying that it considered this "removal action" to be a "medical device recall," terming it "an action taken when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health."

In other news from Medtronic, the company has acknowledged that federal investigators are continuing to examine payments it has made to doctors. The company said in a quarterly filing with the Securities and Exchange Commission in early December that it received a letter from the U.S. Attorney's office for the Eastern District of Pennsylvania requesting documents relating to its relationship with one of its customers and any "payments or things of value" provided by Medtronic to physicians, physician groups, hospitals, medical practices or other entities relating to the purchase of its cardiac resynchronization therapy devices and heart stents.

Medtronic said in the SEC filing that it would comply with the investigation.

In September, Sen. Charles Grassley (R-Iowa) sent a letter to Medtronic concerning its payments to orthopedic doctors using spinal repair products made by the company's Sofamor Danek (Memphis, Tennessee) unit. Overall, those payments appear to have reached $6 million, even after Medtronic made a penalty payment of $40 million last year.

The company also said in its SEC filing that it has received two letters from the U.S. Senate Committee on Finance. The first — sent Sept. 20 — requests information about financial ties made between the medical device industry and practicing physicians. The second letter — sent Oct. 16 — questions Medtronic about its decision to suspend distribution of its Sprint Fidelis family of defibrillation leads. The company again noted that it is cooperating with the requests.

Medtronic also reported in the filing that it received a letter from the SEC on Sept. 25 requesting information relating to "any potential violations of the U.S. Foreign Corrupt Practices Act in connection with the sale of medical devices in an unspecified number of foreign countries, including Greece, Poland and Germany."

The company added that "a number of competitors" have also received similar letters. Then, on Nov. 16, Medtronic received a letter from the Department of Justice requesting any information provided to the SEC. The company also said it would cooperate with both requests.