As if a huge debt, a sagging share price, weakened sales and a variety of regulatory problems aren’t enough, a jury has ordered Boston Scientific (Natick, Massachusetts) to pay $431 million in damages to Dr. Bruce Saffran, a New Jersey radiologist who charged that the medical device maker’s drug-eluting stents (DES) infringe a patent that he received in 1997.

The jury award in U.S. District Court in Marshall, Texas, matches the amount of royalties that Saffran sought from sales of two Boston Scientific stents - the Taxus Express and the LIberte — from 2004 through last September, according to his attorney, Eric Albritton.

The total reflects an 8% royalty on U.S. sales, and a 6% royalty on foreign sales, Albritton said.

Boston Scientific’s Taxus Express DES is its top-selling product, available in the U.S. since 2004 and also sold globally. The Liberte is its next-generation DES product sold globally.

Boston Scientific issued a statement calling the verdict "unsupported by both the evidence and the law" and said it will seek to overturn the verdict in post-trial motions before the district court." If this effort fails, it said it will appeal to the U.S. Court of Appeals for the Federal Circuit.

The company recorded a $365 million charge against its 4Q earnings to cover potential losses due to litigation involving the stents.

Saffran, a radiologist from Princeton, New Jersey, received a patent in 1997 involving a medicated fabric coating to help repair bone fractures. The technology included a method to release medication within the body that Saffran argued works in much the same way as the drug coatings of DES devices.

Some bloggers following the verdict, termed Saffran a "patent troll" and suggested that the verdict will not stand, Gary Hoffman, an attorney for Saffran with the firm Dickstein Shapiro, told the Wall Street Journal that Saffran "is an independent inventor and his contributions to the advancement of medical technology needed to be recognized and rewarded."

Saffran sued Boston Scientific in December 2005. Saffran did not request an injunction, so current sales of the stents are unaffected by the verdict. "We think the verdict is well-supported in the law and in evidence," Albritton said.

A similar patent lawsuit filed by Saffran is pending against Cordis (Miami Lakes, Flroida), maker of the Cypher stent.

Boston Sci sells two units, completing plan of divestirures

In other news from Boston Scientific, the company reported completing the sale of its Fluid Management and Venous Access businesses to Avista Capital Partners for $425 million in cash. The sell-offs were part of its plan to divest non-strategic assets. With these sell-offs, the company said it has divested all five non-strategic units it had previously planned to divest.

It said it expects to record an after-tax gain of about $120 million this quarter in connection with the transaction.

Jim Tobin, president/CEO of Boston Scientific., said the divestitures — "together with our expense and head count reductions and business restructuring -- are helping to realign our cost structure and simplify our operating model. The positive impact of these efforts will help us achieve our overall goals of restoring profitable growth, increasing shareholder value and strengthening Boston Scientific for the future."

Ron Sparks, an Avista healthcare industry advisor, will become CEO and chairman of the new company. Dave McClellan, president of Boston Scientific’s oncology business, will become president of the new company.

Edwards adds Ascendra system to PARTNER valve trial

It is a tale of one transcatheter heart valve (the Sapien) with two approaches: enter through an incision in the groin and thread up through the femoral artery (transfemoral); or enter between the ribs and through the bottom part of the heart (transapical).

Edwards Lifesciences (Irvine, California) reported FDA approval of the addition of its Ascendra transapical delivery system to its Placement of Aortic Transcatheter valves (PARTNER) trial. The agency also gave Edwards permission to increase the trial sample size from 600 to 1,040 patients.

The PARTNER trial, initiated last year, is evaluating the company’s Sapien valve in patients who are considered high risk or inoperable for conventional open-heart surgery.

Until now, clinicians in PARTNER delivered the Sapien valve using Edwards’ RetroFlex transfemoral delivery system by making a small incision in the patient’s groin and threading the catheter up through the femoral artery.

Now, trial clinicians have a second approach to choose from. The Ascendra transapical delivery system delivers the valve by surgically inserting it between the patient’s ribs and entering through the bottom part of the heart.

The transfemoral approach is performed in a cath lab by an interventional cardiologist, whereas the transapical procedure is performed in the operating room by a cardiac surgeon.

Adding the Ascendra transapical delivery system to the trial is important because not all patients who could benefit from the Sapien valve can be accessed through the femoral artery, Larry Wood, VP and general manager of transcatheter replacement at Edwards, told Cardiovascular Devices & Drugs.

"This approval is a really big deal for all the surgeons in the trial because it gives them a chance to do this procedure and help their patients," Wood said.

Every site in the PARTNER trial has a cardiac surgeon co-principal investigator as well as an interventional cardiologist co-principal investigator, Wood said, in an effort to conduct the trial as a team approach.

Thus, the "partnership" between the interventional cardiologist and the surgeon is one rationale for the trial’s title, he said.

"The addition of the transapical approach to the PARTNER trial is an important milestone for cardiac surgeons and their patients. The transapical approach greatly expands the options for patients who need aortic valve replacement, but face excessive risk with alternative approaches," said Craig Smith, MD, chief of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center and the co-principal investigator for PARTNER.

From the company’s perspective, Wood said the addition of the transapical approach should help speed up trial enrollment because a "significant percentage" of patients were getting screened out because of the femoral access issue.

The surgical arm of the trial evaluates the Sapien valve and the two transcatheter delivery systems - Ascendra for transapical access, and RetroFlex for transfemoral access - as compared to surgical, open-heart valve replacement. The medical management arm of the trial evaluates the Sapien valve with the RetroFlex transfemoral delivery system as compared to appropriate medical therapy.

While Edwards has developed one valve (the Sapien) with two approaches (RetroFlex transfemoral or Ascendra transapical), Wood told Cardiovascular Devices & Drugs in March "at the end of the day how you deliver the valve is less important than the valve itself.”

The Sapien transcatheter heart valve integrates balloon-expandable stent technology with a replacement tissue heart valve. The Sapien valve is compressed onto the balloon to about the diameter of a pencil and is threaded through the patient’s circulatory system from either the leg (using the transfemoral approach), or it is inserted between the ribs (using the transapical approach), and expanded directly over the aortic valve.

The merits of transfemoral vs. transapical delivery is an emerging area of controversy in transcatheter valve development, as reported by Cardiovascular Device Update, last spring. Kenton Zehr, MD, of the Heart, Lung and Esophageal Surgery Institute at University of Pittsburgh Medical Center, discussed the topic last year at the annual conference of the American College of Cardiology (ACC; Washington), during a session on percutaneous heart valve therapy.

The transapical approach, which typically is performed via a mini-thoracotomy, can be accomplished either by using beating heart or stopped-heart techniques, i.e., either with or without extracorporeal circulation. That’s why procedures performed using a transapical approach fall into the realm of the cardiac surgeon, whereas those using a transfemoral approach are more suited to the interventional cardiologist.

The Sapien valve with the Ascendra transapical and RetroFlex transfemoral delivery systems is available in Europe.

U.S. Army testing Vicor’s tech to assess injured, ill soldiers

The U.S. Army has signed a Collaborative Research and Development Agreement with Vicor Technologies (Boca Raton, Florida) to investigate technology that could assess the severity of injury, and probability of survival, of critically injured combat casualties and critically ill civilian patients.

Vicor’s PD2i Cardiac Analyzer risk stratifies patients who are at high or low risk of suffering a fatal arrhythmic event or sudden cardiac death (SCD) within a six-month time frame. But the technology can be adapted to analyze any biological stream of data.

"Our initial application is focused on stratifying patients at risk for sudden cardiac death," Vicor president/CEO David Fater told CD&D. "Our technology is being looked at as another vital sign that can be collected relatively easily because it’s based on a digital EKG recording. Our algorithm and software can analyze those heartbeats and can identify those patients who are in need of life-saving intervention."

The Army and Vicor will test the PD2i algorithm in several diverse cohorts of animal data as well as in human trauma, ICU patients and combat casualties. It is expected that the effort will lead to lead to development of new comprehensive decision support tools.

SCD is a leading killer in the U.S., with more than 500,000 annual deaths. It is a fatal arrhythmic event and is different than a heart attack resulting from blood being choked off. SCD is theorized to be caused by a breakdown of the normal neurological communication pattern between the heart and brain, more like an electrical problem, which can lead to a rapid heart rhythm that is usually fatal within minutes. It often has no advance warning or symptoms.

Vicor’s PD2i Cardiac Analyzer is based on an algorithm that the company intends to guard close to home.

"If FDA-approved, we intend to operate like a Quest Laboratory model," Fater said. "Physicians send us a digital EKG file with 1,000 heartbeats. It gets processed through our software and a report comes back that says the patient is positive or negative. Right now, we’re not letting go of the software in the commercial applications because we don’t want any software piracy."

The military application, however, may eventually include hardware loaded with the software.

Vicor’s VITAL Trial (a prospective, multicenter study of the ability of the PD2i Cardiac Analyzer to predict risk of VentrIcular TachyArrhythmic events such as sudden cardiac death, ventricuLar fibrillation or ventricular tachycardia in high-risk patients) was initiated in August 2006 and is being conducted by Harvard Clinical Research Institute (Boston).

The FDA, in pre-investigational device exemption meetings, has agreed to final PD2i protocol and study design for the pivotal VITAL study.

The Vicor product’s closest competitor is Cambridge Heart (Bedford, Massachusetts), with its HearTwave II Microvolt T-Wave Alternans test, which measures a specific and extremely subtle pattern of beat-to-beat fluctuations in a person’s electrocardiogram.

Fater said a primary difference between the two technologies is that Vicor will offer it as a service ($100 per patient analysis), rather than as a stand-alone product that physicians must purchase and keep in their offices.

Cardiovascular Systems files for IPO to raise up to $86 million

Cardiovascular Systems (CS; St. Paul, Minnesota) has filed a registration statement on with the Securities and Exchange Commission for a proposed initial public offering of up to $86.25 million of its common stock, though the exact number of shares and the offering pricing have yet to be determined.

The company’s initial and only product is the Diamondback 360 Orbital Atherectomy System, which it describes as a minimally invasive catheter system for the treatment of peripheral arterial disease (PAD), a circulatory problem in which plaque deposits build up on the walls of vessels, reducing blood flow.

Plaque deposits range from soft to calcified, with calcified plaque being difficult to treat with traditional interventional procedures, and the Diamondback 360 , the company says, is capable of treating a range of plaque types, including calcified vessel lesions. It "addresses many of the limitations associated with existing treatment alternatives."

The system removes both soft and calcified plaque in plaque-lined vessels through the orbital rotation of a diamond grit coated offset crown that is attached to a flexible drive shaft. Physicians position the crown at the site of an arterial plaque lesion and remove the plaque by causing the crown to orbit against it, creating a smooth lumen in the vessel.

Additionally, the Diamondback 360 is designed to differentiate between plaque and compliant arterial tissue. "By giving physicians the ability to create different lumen diameters by changing rotational speed, the company said the system can reduce the need to use multiple catheters of different sizes to treat a single lesion," CS says.

In its SEC filing, the company said that it is not yet profitable. It had net losses of $3.5 million in FY05, $4.9 million in FY06 and $15.6 million in FY07, and $7.4 million in the three months ended Sept. 30, 2007. As of Sept. 30, 2007, it had an accumulated deficit of about $72 million.

In August 2007, the FDA, granted the company 510(k) clearance for use of the Diamondback 360 as a therapy in patients with PAD

Among the risks listed in its filing, CS said that on Dec. 28, 2007, ev3, ev3 Endovascular (Plymouth, Minnesota), and FoxHollow Technologies (Redwood City, California), which recently merged with ev3, filed a complaint, alleging, among other things, misappropriation and use of trade secrets by CS and certain of its employees who were formerly employees of FoxHollow.

The complaint also alleges that these employees violated their employment agreements, with FoxHollow requiring them to refrain from soliciting FoxHollow employees. If the plaintiffs in this litigation are successful, it could have a material adverse effect on the company’s business, operations and financial condition, CS said.

Transoma postpones IPO citing ‘unfavorable’ market conditions

Transoma Medical (St. Paul, Minnesota) reported in early February that it was postponing its initial public offering, citing unfavorable market conditions. The company said it expects to proceed with the IPO "at a future date" when it determines the more appropriate timing.

Transoma makes implantable, subcutaneous, wireless diagnostic and monitoring products. The company is focused on the chronic cardiovascular disease market, through its Patient Management Device division, and the biomedical research market, through its Data Sciences International division.

Earlier the company reported its IPO pricing in the $14-to-$16 range. The IPO was valued at up to $54 million for 4 million shares of common stock.

Transoma first reported filing for the public offering last fall. At the time, it said it had been planning to use the proceeds for working capital and general corporate purposes, and for potential acquisitions of business, technologies and products.

NMT separates roles of chairman and CEO

NMT Medical (Boston) has separated the roles of the chairman and CEO. James Mahoney Jr, who currently serves as chairman of the audit committee and as the board’s financial expert, will assume the position of chairman. John Ahern will continue to serve as the company’s president/CEO and will remain on the board.

"By relinquishing my role as chairman, I can focus more of my energy on operating the company and leading our management team in pursuing the company’s objectives," said Ahern. "Jim has always demonstrated superior leadership skills throughout his career and I am confident in his ability to serve as NMT’s chairman."

Mahoney was elected a director of the company in October. He currently serves as president of the Mahoney Group, a private financial consulting firm. Ahern joined NMT in September 2000 as president/CEO and chairman.

NMT makes implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures.

Harvard launches second round of Accelerator Fund

The Office of Technology Development (OTD) at Harvard University (Cambridge, Massachusetts) has reported the launch of the second round of its Technology Development Accelerator Fund, a new initiative designed to propel emerging technologies originating from the university’s biomedical and life science research community into clinical development and, ultimately, the marketplace.

Six initial projects were funded by the Accelerator in the first round, spanning a myriad of disease areas, at a cumulative budget of $1.3 million.

The Accelerator Fund is now seeking proposals from Harvard faculty for its second round of funding, also of $1.3 million.

The OTD said that inventions arising from one of the first group of research projects supported by the accelerator during its initial year of operation have already been licensed to industry, thus providing early and compelling validation of the fund’s core strategy to boost early-stage inventions to the "take-off" point where they become attractive candidates for commercial development.

Harvard launched the Accelerator Fund last year with $6 million in private donations, and seeks further donations to support additional research to bridge, it said, the development gap encountered when promising early-stage inventions lack validation or proof of concept necessary to attract development partners from industry and the venture capital community.