Direct Flow Medical (Santa Rosa, California), a company developing a minimally invasive implant to treat patients with heart valve disease, reported completing its Series B financing and initiating clinical trials in Europe. Johnson & Johnson Development Corp. and Foundation Medical Partners co-led the $27 million second round of financing and were joined by new investors VantagePoint Venture Partners and ePlanet, as well as existing investors, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners.

The company has developed a catheter-based system to replace the aortic valve percutaneously in patients with valve disease as an option to open surgery. The investigational device is an implantable pericardial tissue valve that allows simple delivery via a transfemoral approach.

Direct Flow said the device's easy positioning —or repositioning — and retrieval features are intended to enable physicians to correctly size and place the device in its targeted location, "providing a new level of safety for patients."

The design also is intended to allow the physician to obtain full hemodynamic data and imaging prior to final device placement.

The company commenced its European clinical trial with the first device implanted in an 81-year-old, non-operative patient at University Heart Center Hamburg (Hamburg, Germany) under the direction of Joachim Schofer, MD, and Hermann Reichenspurner, MD, chief of cardiac surgery.

"The trackability and ease of delivery of the Direct Flow Medical system due to its non-metallic construct will allow true percutaneous delivery in the future," said Schofer.

Lee Wrubel, MD, general partner with Foundation Medical, said, "The capital raised will allow the team at Direct Flow Medical to expand upon the significant progress they have achieved to date and to complete the clinical feasibility phase of device evaluation."

Initially funded by EDF Ventures in 2004, Direct Flow completed an A round of equity financing in August 2005. co-led by Spray Venture Partners and New Leaf Venture Partners.

Cardiology PACS adoption to grow in Australia, F&S says

Frost & Sullivan (F&S) reports that cardiology picture archiving and communications systems (PACS) adoption in Australia "will gain momentum" in the next few years. The F&S report, "Australia Cardiology PACS Market," says that although factors such as cost of the solution and limited awareness are acting as roadblocks at present, "a conscious effort by the solution providers to educate users and the role of information technology in making cardiology workflow more patient-centric and efficient will drive the future growth of this market."

The report indicates that the market was worth A$9.2 million ($7.5 million) in 2006 and estimates it to reach A$15.8 million ($12.9 million) in 2010, growing at an annual rate of some 14.5%.

Consulting analyst Sourabh Kankhar, affiliated with F&S's Sydney office, said, "The demand for higher efficiency in the cardiology workflow is driving the need for cardiology PACS solutions. With the number of cardiac imaging procedures growing each year, cardiologists, cardiac radiographers and technicians will demand access to digitally stored images."

He said that awareness is still low among the key users of these solutions in the cardiology department. "Cardiologists, cardiac radiographers and technicians have a low awareness about the functionality, applications and price of image management and workflow management solutions for the cardiology department."

Therefore, he said, "cardiology PACS providers have to educate cardiologists, cardiac radiographers and technicians that implementation of an image management solution helps the cardiology department to streamline workflow, expedite and improve the delivery of patient care, and use resources more efficiently."

Enrollment increases in trial of OrbusNeich's Genous R stent

Enrollment in the randomized TRI-stent Adjudication Study (TRIAS) trial of the Genous Bio-engineered R stent from OrbusNeich (Hong Kong/Hoevelaken, the Netherlands). The R stent has reached 110 patients since the initiation of the trial in April, according to Robbert de Winter, MD, PhD, principal investigator and director of the cath lab at the Academic Medical Center (Amsterdam, the Netherlands).

The trial, involving about 50 centers throughout Europe, consists of two arms: high-risk for restenosis (HR) and low-risk for restenosis (LR). The primary endpoint in both is target vessel failure within 12 months, with clinical follow-up extending to five years.

In the HR arm, about 1,250 patients will be enrolled for a non-inferiority study of Genous vs. Taxus or Cypher drug-eluting stent (DES). In the TRIAS LR arm, about the same number of patients will be enrolled for a superiority study of Genous vs. bare metal stents (BMS).

Noting concerns about thrombosis with DES use, de Winter said, "The dual antiplatelet therapy requirement for Genous is only 30 days. Drug-eluting stents require a minimum of six months of dual antiplatelet therapy, which gives rise to many patient compliance and cost issues."

TRIAS participants will receive one week of statin therapy pre-procedure. Patients treated with a Genous or BMS will receive 30 days of clopidogrel post-procedure, while patients treated with a Taxus or Cypher DES will receive at least six months of clopidogrel post-procedure.

The Genous stent is coated with an antibody to capture a patient's endothelial progenitor cells, and, therefore, accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. The company said that when attracted to the surface of the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis.

Coherex reports 1st human procedures for its PFO system

Coherex Medical (Salt Lake City) reported completing the first human cases with its Coherex FlatStent PFO Closure System. Horst Sievert, MD, principal investigator for the COHEREX-EU study, conducted procedures at Sankt Katharinen Hospital (Frankfurt, Germany), in October to close a patent foramen ovale (PFO), a heart defect that occurs in roughly 25% of the population.

PFOs allow blood to bypass the lungs and shunt directly from the right side of the heart to the left, thus increasing the likelihood that blood clots in the heart flow directly to the brain and preventing the filtration of chemicals out of the blood that occurs in the lungs.

"The Coherex FlatStent PFO Closure System worked flawlessly during each of our procedures," Sievert said. "The device was extremely easy to use and there have been no complications from its use in any of the cases."

He said that the FlatStent "marks the beginning of a new era of medical device technology and significantly raises the bar by providing a simple and safe alternative in PFO closure for physicians and their patients."

Coherex said there are at least two medical conditions that may benefit from PFO closure: stroke and migraine.

According to the American Heart Association (Dallas), some 500,000 strokes each year worldwide may be attributable to the presence of a PFO, which represents a potential annual market size of close to $2 billion. And multiple retrospective studies have demonstrated a marked reduction in migraine symptoms following PFO closure. The worldwide market potential for PFO closure to treat migraine patients has been estimated to be more than $15 billion a year.

deCODE MI launched for early detection of MI risk

deCODE genetics (Reykjavik, Iceland) has launched deCODE MI, a reference laboratory test for variations in the genome (called SNPs) that the company has associated with increased risk of myocardial infarction, or heart attack. The variants detected by deCODE MI are two SNPs on chromosome 9p21, discovered by company scientists earlier this year through genome-wide SNP analysis in Iceland and replicated in three cohorts of European descent from Philadelphia, Atlanta, and Durham, North Carolina.

Of the 17,000 patients and control subjects in the study, more than 20% of participants carried two copies of the variant, corresponding to a more than 60% increase in risk of heart attack, regardless of age of onset, compared to those without the variant.

In early-onset cases — men and women who suffered a heart attack before the ages of 50 and 60, respectively — carrying two copies of the variant corresponds to an approximate doubling of risk compared to non-carriers. The variant is estimated to account for about one-fifth of the incidence of heart attack in populations of European origin, and nearly one-third of early-onset cases, making it the one of the most significant genetic risk factors found to date for heart attack, the company said.

deCODE said other researchers have replicated this finding in several European, U.S. and Canadian cohorts.

"With the launch of deCODE MI, we have taken another of our breakthroughs in genetics and transformed it into a new tool in the fight to prevent heart attack," said Dr. Kari Stefansson, CEO of deCODE. "While many risk factors for heart attack are understood, the disease remains the leading cause of death in the industrialized world and the early-onset cases often take both patients and doctors by surprise."

Stefansson said deCODE MI tests for a genetic risk factor that is independent of other risks such as cholesterol, obesity and smoking, "and therefore provides a means of identifying individuals who may derive particular benefit from earlier and more aggressive prevention efforts."

deCODE MI is performed in deCODE's CLIA-certified laboratory and must be authorized by a qualified physician.

Stereotaxis says catheter procedures for AF are completed

Stereotaxis (St. Louis) reported that the first atrial fibrillation (AF) procedures performed with its partnered magnetic irrigated catheter were successfully completed recently. The magnetic irrigated catheter has CE-mark approval for the remote ablation of arrhythmias and is being released "in phases" to physicians in Europe, the company said.

"The first uses of our partnered irrigated catheter in Europe are a double achievement," said CEO Bevil Hogg. "First, the cases were remarkable for their efficiency and efficacy, and we are extremely pleased with the results. Secondly, combined with our Stereotaxis Magnetic Navigation System and new NaviLine software, the irrigated catheter completes Stereotaxis' total solution for atrial fibrillation, a solution that we believe will significantly advance the treatment of complex arrhythmias and potentially become standard of care for a growing number of cases."

Hogg added, "Near-term, we believe that widespread adoption of our partnered magnetic irrigated catheter in Europe will bring even greater simplicity and safety to AF procedures performed there, and we look forward to these clinical benefits becoming available to patients and clinicians in the U.S. after appropriate regulatory approval."

Stereotaxis manufactures a cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites.

The system uses computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting, the company said, in "improved navigation, shorter procedure time and reduced X-ray exposure."

The core components of the Stereotaxis system have received clearance in the U.S., Europe and Canada, but use of cardiac ablation catheters for treatment of AF still is considered investigational in the U.S., the company said.

Clinical Data unit in pact for LQTS testing in Australia

Clinical Data (Newton, Massachusetts) reported that its PGxHealth division has entered into a non-exclusive, sub-license agreement with Australia's Victorian Clinical Genetics Services (VCGS; Victoria) to provide genetic testing for familial long QT syndrome (LQTS).

The agreement with VCGS — a not-for-profit subsidiary of the Murdoch Children's Research Institute (Victoria), Australia's largest children's research institute — covers LQTS testing to individuals and families in Australia and New Zealand.

LQTS is an inherited disorder of the heart's electrical system. It causes a sudden, unexpected, life-threatening type of ventricular tachycardia, and people who have LQTS are at risk for syncope and possibly sudden death, often at a young age.

John Schultz, senior VP of licensing and strategic development at PGxHealth, said, "Sudden arrhythmia death is a tragic occurrence. However, with today's diagnostic tools and treatments, heart rhythm abnormalities are a manageable health condition. This test not only can aid in the diagnosis of LQTS and help determine whether family members are at risk but may also guide treatment options for those who have exhibited symptoms."

He added: "By partnering with a world-famous institution such as the VCGS and Murdoch Children's, we are confident that the test will be of the highest quality and made accessible to the community in the widest manner possible."

Professor Agnes Bankier, director of the VCGS, said, "Our mission is to provide clinical and laboratory testing, as well as counseling and support to help people with genetic conditions make informed decisions about their health and well-being. This agreement supports our efforts to do so."

PGxHealth is involved in the development, clinical validation and delivery of genomics-based tests, in particular of efficacy and safety biomarkers for appropriate drug use. It has branded its genetic tests based on these proprietary genetic markers Therapeutic Diagnostics.

Sorin wins FDA approval of aortic pericardial heart valve

The Sorin Group (Milan, Italy) said it has received FDA approval for marketing of its Mitroflow Aortic Pericardial Heart Valve in the U.S.

The company noted that biological valves have become "an increasingly viable option to replace native diseased valves, since they are designed to improve patient quality of life by negating the need for lifelong anticoagulation therapy."

The Mitroflow Aortic Pericardial Heart Valve will be distributed in the U.S. by American heart valve subsidiary CarboMedics (Austin, Texas). The commercial launch is scheduled for December.

Sorin introduced the Mitroflow Aortic Pericardial Heart Valve in Europe in 1982. It said that in its long years of clinical use, the valve has demonstrated "superior hemodynamic performance and long-term durability in a design recognized by surgeons worldwide as facilitating implant in even the most challenging anatomies."

Joseph Bavaria, MD, professor and vice chief of cardiovascular surgery at the Hospital of the University of Pennsylvania (Philadelphia), said, "Mitroflow will allow U.S. cardiac surgeons to use an innovative and clinically proven biological heart valve leading to excellent hemodynamic performance. Frankly, it [Mitroflow] is one of the easiest aortic heart valves I've ever implanted. I especially like the flexible cuff."

Bavaria is a principal investigator in the Mitroflow investigational device exemption (IDE) trial in the U.S.

Endeavor DES CE-marked, launch will be sooner than expected

With receipt of the CE mark for the Endeavor Resolute drug-eluting coronary stent (DES), Medtronic (Minneapolis) said it plans to launch the product outside the U.S. sooner than originally expected.

The company said the Endeavor Resolute stent will be launched in more than 50 countries in Europe, Asia, the Middle East and Africa by the end of 2007, making Medtronic the first company to offer two internally developed drug-eluting stent options for the treatment of coronary artery disease. The new DES is not yet approved in the U.S.

The company said the Endeavor Resolute "leverages the strengths of the Endeavor" DES, which was launched in Europe in July 2005 and is now available in more than 100 countries outside the U.S. They share the same cobalt alloy stent platform which, the company said, "provides excellent radial strength and conformability to the vessel wall," and both use the non-cytotoxic drug zotarolimus.

In addition to the Endeavor Resolute and Endeavor DES devices, Medtronic offers the Driver bare-metal stent (BMS).

"The Endeavor Resolute drug-eluting stent and the BioLinx polymer represent two important achievements of our product pipeline and demonstrate our commitment to innovation in interventional cardiology," said Scott Ward, president of Medtronic's cardiovascular business.

"With the combination of Driver, Endeavor and Endeavor Resolute, [we are] delivering safe and effective options for physicians to treat a broad range of patients with coronary artery disease."

Endeavor Resolute uses a biocompatible polymer called BioLinx, which the company said is designed to confer the same biocompatibility as the Endeavor stent's phosphorylcholine polymer while extending the duration of drug exposure in the vessel.

Developed by Medtronic scientists, BioLinx is the first polymer created specifically for DES use. "The BioLinx polymer features a unique blend of hydrophilic and hydrophobic elements for optimal performance," the company said in a statement.

It said extensive preclinical studies have established the biocompatibility and drug delivery capabilities of the BioLinx polymer.

Dutch cardiologist Patrick Serruys, MD, performed the first commercial implant of the Endeavor Resolute stent at the Heartcenter Rotterdam on Oct. 10. "We now have a new drug-eluting stent for our patients with a breakthrough in coating technology," he said.

"Endeavor Resolute provides the excellent safety profile of the Endeavor stent with extended delivery of the drug zotarolimus," Serruys said. "To further evaluate the safety and efficacy of the new stent in real-world clinical practice, we have designed a post-market European study involving more than 2,300 patients."

Patients treated with the Endeavor Resolute DES in the initial RESOLUTE clinical trial required no repeat procedures through nine months and had experienced no protocol-defined stent thrombosis through 12 months of follow-up.

In-stent late lumen loss at nine months, the study's primary endpoint, was met, providing assurance of vessel healing in the targeted range and avoiding repeat procedures.

Among the trial's 130 patients, only one required clinically-driven target lesion revascularization or target vessel revascularization through 12 months. The incidence of major adverse cardiac events was 8.5% through 12 months. The 12-month results from RESOLUTE were available in abstract form at this week's Transcatheter Cardiovascular Therapeutics meeting in Washington.

"The RESOLUTE clinical results are impressive considering the enrolled patients presented with especially complex and challenging characteristics," said the trial's principal investigator, Ian Meredith, MD, of Monash Medical Center (Melbourne, Australia).

Medtronic said it plans additional ctrials of the Endeavor as part of a program to characterize ong-term safety/efficacy in various patient populations. The program will enroll about 13,000 patients in a series of randomized controlled trials and registries in the U.S. and internationally.

In other CE mark news:

• InspireMD (Tel Aviv, Israel) received CE-mark approval for its MGuard Coronary Stent, clearing the way for marketing in Europe, Latin America, Asia and Africa.

Ofir Paz, CEO and chairman, said, "MGuard receives the 'green light' to compete in a market worth more than $3 billion annually. Designed to enhance the safety of stenting procedures, we are confident that MGuard Coronary provides advantages over other available coronary stents and is well positioned to capture a significant share of this large and growing market."

The MGuard Coronary stent presents a combination of a coronary stent merged with an embolic protection device. The embolic protection device is comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent.

The protective sleeve is composed of a micron-level-fiber knitted mesh, engineered in a geometric configuration and designed, the company said, "for utmost flexibility while retaining strength characteristics of the fiber material." The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post procedure.

InspireMD said the MGuard stent provides "long-acting embolic protection, without adding complexity in deliverability. The sleeve is designed to diffuse stent pressure on the vessel wall, thereby may reduce injury and lower the likelihood of restenosis."

In ongoing clinical trials in Germany, the MGuard Coronary has achieved a procedural success rate of 100% with no report of any major adverse cardiac events, the company said.

Dr. Asher Holzer, InspireMD president, said, "We have already received pre-launch orders valued at over $1.5 million, and the CE mark paves the way to generate significant sales volume and wide market adoption of our proprietary stent platform technology."

InspireMD said it will pursue applications of the MGuard technology both for BMS and DES devices in coronary, carotid and peripheral artery procedures.

• Occlutech (Jenna, Germany), a developer of cardiac occlusion devices, said it has received CE-mark approval for its line of atrial septal defects (ASD) and patent foramen ovale (PFO) occluders under the Occlutech Figulla N brand.

The company said the fact that its ASD and PFO occluders are not clamped gives them "distinct advantages" such as increased flexibility and a reduction of the amount of material implanted.

Starting in Germany, the products will be rolled out in Europe and in other international markets over the next few months.

Occlusion devices are used to treat structural heart disease, including structural heart defects and abnormalities, such as ASD or PFO, in a minimally invasive, non-surgical way.

Occlutech said the market for these devices, the PFO occluder in particular, "is expected to expand significantly over the next few years."

• Angiotech Pharmaceuticals (Vancouver, British Columbia), received the CE mark for its Quill Self-Retaining System (SRS) Monoderm sutures in Europe. FDA clearance for the sutures was received in August. The product is made by Quill Medical, an Angiotech subsidiary.

Quill SRS Monoderm sutures, made from a rapidly-resorbing polymer, are intended primarily for superficial wound closure applications and indicated for soft-tissue approximation where use of an absorbable suture is appropriate.

Angiotech said the Quill SRS represents "a revolutionary technology in wound closure made possible by bidirectional fixation within the wound. Its patented design allows the surgeon to begin closure at the midpoint of the wound and suture in two directions from the midpoint." Barbs within the Quill SRS distribute tension across the wound and eliminate the need for knots.

The company said the "highly efficient, knot-less system" can save "significant" procedural time in the OR, while also enhancing wound closure.