UK venture capital firm Scottish Equity Partners (SEP) led a $17 million investment in Heartscape Technologies (Columbia, Maryland), which recently launched a device for the early diagnosis of heart attacks in emergency department (ED) patients.

The company said its device, the Prime ECG, has received FDA approval. The device is intended to provide doctors with more detailed images and information on a patient's heart than traditional ECGs.

"For heart attack victims rapid diagnosis can mean the difference between life and death and impacts a patient's long-term prognosis. A significant opportunity exists for Prime ECG to benefit patients by improving the speed of diagnosis and hospital efficiency in managing high-risk cardiovascular patients," said Heartscape Technologies CEO Arthur Hiller.

Heartscape said it would use the new funds for the commercial launch of Prime ECG in the U.S. and for further clinical development.

SEP led second-round funding as part of an international investment syndicate, which includes Investor Growth Capital of Sweden and existing investors Radius Ventures (New York) and Delta Partners (Ireland).

"Prime ECG represents the first major advance in non-invasive cardiovascular diagnostic devices for year," said Brian Kerr, investment director of SEP's Healthcare and Life Sciences team. "Clinical results have demonstrated its effectiveness as a front-line diagnostic tool, and we believe it has the potential to become the standard of care in this field. It is precisely this sort of breakthrough and disruptive technology that builds value for investors and increases the standard of healthcare. We are pleased to add Heartscape to our portfolio of healthcare pioneers."

The Prime ECG system, initially developed from technology licensed from the University of Ulster in Northern Ireland, is comprised of a disposable plastic vest with 11 self-adhesive plastic strips containing 80 data collection points or leads which are attached to the front and back of a patient's body, the company said. It is designed to allow doctors to gather critical information that may not be visible with traditional ECG devices.

Medtronic reports Japanese MOMIJI CRT-D trial as a first

Medtronic (Minneapolis) last month reported the launch of its Miracle-ICD Outcome Measured In Japanese Indication (MOMIJI) clinical trial, calling it the first large-scale, post-market study in Japan by a medical device company. MOMIJI, a prospective, multi-center study enrolling up to 250 patients at about 25 centers, will evaluate the effectiveness of cardiac resynchronization therapy-defibrillator (CRT-D) in Japanese patients as compared to patients studied in the MIRACLE-ICD trial. The MIRACLE-ICD trial evaluated the efficacy of CRT-D in heart failure patients in the U.S.

The trial is the result of collaboration between Medtronic Japan and three well-known Japanese physicians: heart failure specialists Shin-ichi Momomura, MD, a professor at Omiya Medical Center of Jichi Medical University; Hiroyuki Tsutsui, MD, a professor at Hokkaido University; and electrophysiologist Kaoru Sugi, MD, a professor at Toho University Ohashi Medical Center.

Medtronic said that since 1997 it has supported more than 20 randomized trials evaluating device therapy in more than 8,000 heart failure patients outside of Japan. The company said those trials — including the Sudden Cardiac Death in Heart Failure Trial and Cardiac Resynchronization in Heart Failure studies — have confirmed the efficacy of ICDs with CRT technologyamong certain heart failure patients.

It said MOMJI is the first trial that will focus on the effectiveness of CRT-D therapy in a Japan-only cohort, and that it may help to determine if the results of foreign trials apply to the Japanese population.

Eligible devices for this trial include InSync III Marquis CRT-D, which the company said is the No. 1 selling CRT-D device in Japan, and future Medtronic CRT-D devices as they become commercially available. Combining cardiac resynchronization and defibrillation therapies in a single system, the device received reimbursement approval in August 2006 and has been available for six months.

Australia approves 3 products from Abiomed

Abiomed (Danvers, Massachusetts) has received regulatory approval in Australia for three of its Impella products: the Impella LP 2.5 percutaneous left ventricular assist device, Impella LP 5.0 and Impella LD.

The devices will be distributed in Australia through N. Stenning & Co., Abiomed's distributor for the AB5000 and BVS 5000 Circulatory Support Systems.

According to the National Heart Foundation of Australia, cardiovascular disease is the leading cause of death and disability in Australia, with some 3.7 million Australians affected.

Michael Minogue, predident/CEO and chairman., said, "We are pleased to work with Australian clinicians and provide our Impella technologies to patients in acute heart failure, to help rest and potentially recover their native hearts."

The Impella 2.5 is a ventricular assist catheter inserted percutaneously in the cath lab via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The system, which provides cardiovascular support for up to five days, is currently available in Europe and is in pilot studies in the U.S under an Investigational Device Exemption (IDE).

The Impella 5.0 consists of catheters introduced percutaneously through a cut-down (Impella LP5.0) or surgically (Impella LD). These pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion.

The Impella 5.0 catheters, which are intended to be used for up to seven days as left ventricular cardiac assist devices, have the CE mark and are in pilot studies in the U.S. under an IDE.

New data on CryoCath's Arctic Front presented

CryoCath Technologies (Montreal), a developer of cryotherapy products to treat cardiovascular disease, said that additional data on its Arctic Front catheter system to treat atrial fibrillation (AF) was presented at the annual conference of the German Cardiac Society (Dusseldorf, Germany) in April.

CryoCath sponsored a cryotherapy symposium featuring presentations by Dr. Julian Chun and Dr. Matthais Antz of Asklepios Klinikum St. Georg (Hamburg, Germany), Professor Burghard Schumacher of Rhon-Klinikum (Bad Neustadt) and Professor Luc Jordaens of Erasmus Thoraxcentre (Rotterdam).

The clinicians presented acute and three-month data on a total of 150 patients following ablation procedures. Acutely, more than 90% of the pulmonary veins were successfully isolated. When pulmonary vein isolation was achieved, 75% of patients were AF-free after three or more months following a single procedure, CryoCath said.

No stenosis, thrombosis, esophageal perforation or stroke events were reported at any of the centers, and no left atrial flutters, a common occurrence following RF ablation procedures, were observed.

"This European data demonstrates that Arctic Front is a practical tool for the treatment of AF in a typical EP lab setting," said Jan Keltjens, president/CEO of CryoCath. "It demonstrates that it is feasible to isolate pulmonary veins in a very high percentage of cases using Arctic Front alone."

Cordis launches Dura Star Rx angioplasty catheter in Europe

Cordis (Miami Lakes, Florida) reported European launch of the Dura Star Rx percutaneous transluminal coronary angioplasty dilatation catheter. The Dura Star Rx (RX for rapid exchange) catheter is intended to facilitate the post-delivery expansion of stents in coronary arteries and for tackling tortuous anatomy and calcified lesions. It has been designed to provide interventional cardiologists with controlled and even expansion of the balloon to the correct diameter, minimizing the potential for artery damage to the patient.

This new dilatation balloon will be introduced in other regions, including North America, later in the year, Cordis said.

"The Dura Star Rx performed well under challenging circumstances," said Andreas Baumbach, MD, of Bristol Royal Infirmary (Bristol, UK), who conducted some of the earliest cases with the balloon in Europe. "It is excellent for post-delivery dilatation of stents. It entered and exited the stent easily. It gave controlled and precise expansion to the correct diameter and did not distort at high pressure."

Cordis said the Dura Star Rx catheter is suited for use in both drug-eluting and bare-metal balloon-expandable stents. "Its short and soft tip facilitates crossing stent struts and calcified lesions," the company said. "Designed to reduce the risk of 'kinking' and equipped with a lubricating coating, the Dura Star Rx . . . provides easier delivery to the site of a lesion, especially in challenging cases."

Enrollment in COREL stent trial under way in India

Cinvention (Weisbaden, Germany) and Relisys Medical Devices (Malakpet, India) recently reported enrollment of the first patients in the COREL drug-eluting stent trial. COREL is a prospective, open-label, randomized clinical trial that will enroll 150 patients in 10 centers in India. Enrollment in the study will be carried out through 10 clinical trial centers in Ahmadabad, Bangalore, Chandigarh, Hyderabad, Mumbai, New Delhi and Vellore.

Principal investigator of the study is Balram Barghava, MD, of the All India Institute of Medical Sciences (New Delhi).

The primary endpoint is nine-month in-stent late loss within the stented segment post-procedure and historical comparison with six- to nine-month in-stent late loss with other drug-eluting stents. Secondary endpoints include angiographic binary restenosis, target lesion revascularization, target vessel revascularization and target vessel failure rates at nine months; major adverse cardiac events; acute, sub-acute and late stent thrombosis at 30 days and nine and 12 months; lesion, device and procedure success.

Relisys' Corel + C drug-eluting stent includes a cobalt-chromium stent that is coated with a macro-porous, nano-structured, carbon-composite matrix containing the active drug paclitaxel. Developed and provided by Cinvention, the coating eliminates the use of polymers and provides a bioactive coating with less thrombogeneity and pro-endothelialization surface design, which the company said reduces tissue inflammation and reaction, while enhancing engraftment and endothelialization.

CardioTech reports 1st CardioPass patient discharged

CardioTech International (Wilmington, Massachusetts) reported last month that the first patient in its European clinical trial of CardioPass, the company's synthetic coronary bypass graft, has been discharged from the medical center where the coronary bypass surgery was performed. This is the company's first human clinical trial for European regulatory approval of the graft.

Michael Adams, president/CEO of CardioTech, called the procedure "an important accomplishment — we are pleased that our trial patient was discharged from the hospital in a similar timeframe that it takes for ordinary coronary bypass procedures."

CardioTech said it would not comment on trial results until its European Notified Body makes its determination based on the clinical data on the approved 10-patient protocol, which calls for each patient to be followed up for 90 days after CardioPass has been implanted. This process is expected to take about nine months.

CardioPass is designed as an alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20% of all bypass procedures. CardioPass is made from ChronoFlex, the company's biodurable medical-grade polymer.

Once it is implanted, the graft is designed to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex has been formulated to be flexible, enabling CardioPass to pulse like a human vein would as it carries blood to the heart.

Angeon unit opens European branch in Italy

Angeion (St. Paul, Minnesota) reported that its Medical Graphics business has opened a European branch office in Milan, Italy, to house the firm's business development manager, as well as technical and field service support. The company said the new office will facilitate growth in international markets, provide marketing support to distribution partners and expand clinical research support.

"Recent growth in our Medical Graphics international cardio-respiratory business, combined with the number of European-based clinical research sites utilizing our diagnostic systems and services, necessitate our presence in Europe," said Rodney Young, president/CEO of Angeion.

Medical Graphics manufactures non-invasive cardio-respiratory diagnostic systems sold under the MedGraphics and New Leaf brand and trade names, with various application in health and fitness.

Cardica, Century, extend pact for PAS-Port system in Japan

Cardica (Redwood City, California) and its Japanese distributor, Century Medical, have extended an agreement to distribute the PAS-Port Proximal Anastomosis System in Japan through July 2014.

Toshio Konishi, president/CEO of Century, said, "Currently, over 330 doctors at 220 hospitals throughout Japan have been trained on the PAS-Port system, and today, we have over 20% market share of all proximal anastomoses performed using a vein bypass graft during CABG surgery in Japan."

Cardica and Century also agreed to restructure Cardica's $3 million note to Century. Cardica will make a principal payment of $1 million toward its outstanding indebtedness to Century, the remaining $2 million to be due in June 2010, two years beyond the original maturity date.

Bernard Hausen, MD, PhD, president/CEO of Cardica, said the restructuring enables the company to apply more of its cash reserves to the commercialization and development of its automated anastomosis systems.

Kensey Nash wins expanded approval for TriActive ProGuard

Kensey Nash (Exton, Pennsylvania) last month reported expanded European approval for its TriActiv ProGuard blood clot protection device. The company received CE-marking to use its TriActiv ProGuard system in procedures involving the carotid artery. The system already is approved for saphenous vein graft procedures, in which a patient's blood vessel, usually from the leg, is harvested to bypass a blocked heart artery. The new indication allows use of the system in stenting procedures.

The TriActiv ProGuard uses a balloon protection guidewire, a flush catheter and an automated extraction system to prevent stray debris or blood clots from breaking off and causing a stroke. The system can be used in combination with any approved carotid stent, the company said.

For European approval, Kensey Nash used data from a clinical trial showing no major strokes or death in 50 patients. The company is enrolling up to 400 patients in a study to support U.S. approval.

Atrium Medical wins CE mark for ClearWay RX catheter

Atrium Medical (Hudson, New Hampshire) said it has received the CE mark for a new small-vessel therapeutic perfusion catheter, the ClearWay RX. The catheter is indicated for localized delivery of therapeutic agents to the coronary and peripheral vasculature.

The company said ClearWay RX is "the world's first rapid-exchange therapeutic perfusion catheter for localized therapeutic delivery within small-caliber vessels. Delivering a smaller quantity of a preferred therapeutic agent locally has been shown to help reduce systemic effects."

ClearWay RX is a low-pressure perfusion catheter incorporating a thin, semi-compliant microporous PTFE balloon material to deliver small quantities of medication. The microporous balloon allows for controlled infusion at very low pressures (2 atm to 4 atm) for maximum local therapeutic effect at a discrete targeted location.

The rapid exchange catheter is .014" guidewire-compatible, allowing access to difficult-to-reach target destinations throughout the body.