CD&D and Staff Reports

A research team led by the French surgeon who re-engineered mitral valve repair said it will implant up to 20 artificial hearts in patients in 2011. At a press conference in Paris, Alain Carpentier, MD, said, "We are moving from pure research to clinical applications. After 15 years of work, we are handing over to industry to produce an artificial heart usable by man," according to Agence France Press.

Few medical devices begin life with such an impressive pedigree.

Carpentier was given carte blanche from the European space and defense group EADS, which estimates it already has spent more than e15 million bringing the project to a prototype stage.

The heart device is pre-approved by the French Agency for Healthcare Product Safety (AFSSAPS) for implantation in "life-threatened patients with no other available treatment options," meaning a patient who otherwise might drop dead of a massive heart attack.

The French innovation agency OSEO awarded the company transferring the technology from the labs to the market some EUR 33 million in grants and loans, the largest amount of funding ever awarded to a start-up.

And the new company, Carmat SAS, raised in excess of e7 million in a first financing round, with e5 million from Truffle Capital (Paris) and e2.25 million from EADS and the Fondation Alain Carpentier.

"It's nice to have more cash than you plan to burn," Dr. Philippe Pouletty, the managing director of Truffle, told Cardiovascular Devices & Drugs.

"We have not done any detailed market studies," he said.

The partners believe simply that if the implanted heart results in low survival rates and a low quality of life for the patients, then the market prospects will be low.

"Yet if this is successful with a high survival rate, we believe the potential is very high," Pouletty said. "As far as we know, there is no other project to create an artificial heart that combines all of these factors, though we sincerely hope there will be, as there is a tremendous medical need."

At the Paris press conference, the partners said they estimated the shortfall in heart donors to patients awaiting a transplant will reach 20,000 by 2011.

One of the primary indications for the Carmat heart will be serving as a bridge to transplant for patients who are expected to receive a heart within a one-year to two-year period, said Pouletty.

Accelerated testing of the device encourages the partners to believe the heart's components, including power supply, can function for over three years and as high as five years.

The third indication for the device is elegantly stated as a "destination therapy for long-term use."

According to AFP, the partners acknowledged that several teams around the world are developing fully implantable artificial hearts including the AbioCor from the American company Abiomed (Danvers. Massachusetts), which was used in 14 trials between 2001 and 2004, with patients surviving an average of 5.3 months.

Affiliated with the Georges Pompidou Hospital in Paris, Carpentier is credited with ushering in the modern era of valve reconstruction as the inventor of the Carpentier-Edwards mitral porcine valve, or bioprosthesis, as he prefers to call it.

He also developed the the Carpentier-Edwards ring, and a surgical technique called the "French correction," designed to avoid a prosthesis altogether

In 1993, Dr. Carpentier approached French industrialist Jean-Luc Lagadere to solicit his support for the heart project.

As Pouletty told the story to CD&D, Carpentier had successfully operated on a few friends of Lagadere and won the unconditional support of the founder of EADS.

Carpentier "thought the device would be too complicated for a traditional medical technology approach with its complex electronics, high-technology and a compact design," Pouletty said.

In other words, creating this heart was going to be rocket science, so who better to develop it than scientists who build compact, stand-alone remote systems such as satellites and the onboard electronics for missiles.

"Especially systems with onboard back-up in the event one of the systems fails," said Pouletty.

"The EADS team has overcome many challenges," he said, including designing an independent operation of two ventricles with separate ejection flows, inventing sensors to regulate blood flow and pressure, solving problems such as low heat production for the unit, low energy consumption, and managing blood clotting, the first adverse event resulting from any heart device implantation.

The Carpentier valve design team brought an expertise for placing biologic membranes on the inside of the heart while the EADS team engineered synthetic polymers membranes for the exterior, Pouletty said.

The prototype, which has been tested in animals, is shaped like a human heart and mimics the dynamics of heart pressures and flows, with a sensitivity to patient activity and orientation, such as standing or lying down.

The device runs off a belt-mounted battery pack for five hours, and built-in software allows it to be remotely monitored and diagnosed.

The Carmat prototype is patented and the device is now undergoing pre-clinical testing and fine-tuning, with the next milestone to be a design freeze ahead of evaluation, Pouletty said.

A management team will be put in place over the next 12 months to bring the device to market, he said, including converting a bench-built prototype to a manufacturable model.

The Carmat heart "opens the field for autonomous, self-regulating, complex bioprosthese, a very broad area in the interventional medicine of the future," said Pouletty.

HMRI stroke group cites benefits

The Hunter Medical Research Institute (HMRI) Stroke Research Group says it has developed a system to fast-track stroke treatment, which could benefit thousands of Australian stroke patients and save millions of dollars annually. The system (called the Pre-hospital Acute Stroke Triage or PAST Protocol) reduces pre-hospital and emergency department delays to allow more stroke patients to receive brain saving thrombolysis or clot busting treatment within the three-hour treatment window, according to the HMRI group.

Results of the Australian-first trial conducted at John Hunter Hospital (New South Wales) are published in the latest Medical Journal of Australia.

"By reversing the crippling effects of stroke we are enabling more people to return to their families, their homes and their jobs. This also reduces the demand on nursing home beds, in-hospital rehabilitation programs and the health care dollar," said lead investigator Debbie Quain, a member of the HMRI group and a Hunter New England Health Stroke Research Nurse.

As a result of the protocol, the number of patients treated with thrombolytic therapy at John Hunter Hospital rose from 4.7% to 21.4%. Of those treated, 43% had minimal or no disability three months after the stroke. Currently, less than 1% of patients who have experienced an ischaemic stroke receive thrombolysis treatment in Australia, the group noted. The world best practice rate is 15% to 20%.

"If the PAST protocol is implemented nationally, an additional 2,500 patients could receive thrombolysis treatment each year and an estimated cost saving of $31.2 million dollars per annum will be realized," said Associate Professor Chris Levi, head of the HMRI Stroke Research Group and director of Acute Stroke Services at John Hunter Hospital.

The protocol equips ambulance officers with a stroke assessment tool to more accurately identify patients who may benefit from clot busting treatment, gives the ambulance control officer phone contact with a stroke neurologist to identify 'out of area' patients who may be eligible for treatment, and allows an on-call acute stroke team to respond and provide immediate care for the patient on arrival at hospital.

The research was conducted by the HMRI Stroke Research Group in collaboration with the Ambulance Service of NSW Northern Division and the John Hunter Hospital Emergency Department.

1st implantation in Japan for DuraHeart LVAS

Terumo Heart (Ann Arbor, Michigan) said the first DuraHeart Left Ventricular Assist System (LVAS) was implanted last month at the University of Tokyo Hospital.

Its parent company, Terumo Corp., said it would continue its efforts toward an early application for approval for manufacture and sales in Japan.

Terumo's LVAS is a third-generation LVAS combining a centrifugal pump with a magnetically levitated impeller. The product received the CE mark in Europe in 2007 and began its U.S. pivotal trial in July.

The Mag-Lev centrifugal pump technology was developed by Dr. Akamatsu, former professor of the faculty of engineering at Kyoto University (Kyoto, Japan), in collaboration with NTN Corp.

The development base was moved to the U.S. in 2000 to continue product development and commercialization efforts.

The company noted that the Japanese Ministry of Health, Labor and Welfare has highlighted implantable left ventricular assist devices in its "Early Introduction of Medical Equipment with Medical Needs" program.

Terumo's focus is the development of products to improve the quality of healthcare for heart failure patients. Terumo Corp., headquartered in Tokyo, is a manufacturer of a wide array of medical products.

DuraHeart is limited to investigational use only in the U.S., and is CE-marked in Europe.

European release for Cook microcatheter

William Cook Europe (Bjaeverskov, Denmark), a unit of Cook Medical (Bloomington, Indiana), reported receipt of CE-mark approval for its MiraFlex High Flow Microcatheter.

Engineered to complement the existing offering of Cook embolization products and coils, MiraFlex High Flow embodies, according to Cook, "the latest innovation in microcatheter technology designed to enhance traceability necessary for accessing the most distal vasculature." The catheter is indicated for use in small-vessel or super-selective anatomy for diagnostic and interventional procedures.

Rob Lyles, global leader of Cook's peripheral intervention division, said, "We are . . . pleased to introduce MiraFlex High Flow to the European market, and look forward to bringing this device to clinicians for use in neurological, peripheral or coronary vasculature practices."

Featuring a .025" inner diameter, MiraFlex High Flow enables optimal coil delivery and can be used in combination with a wide variety of embolization materials, including the top-selling MicroNester and Tornado Microcoils from Cook.

The company said a kink-resistant braided construction along the entire length of the catheter shaft to the radiopaque band "provides improved torque response and traceability for quicker vessel selection, while maintaining optimal catheter visualization." The braided design also contributes to the flexibility and durability of the catheter, which carries a rated burst pressure of 1000 psi and achieves the higher flow rates clinicians depend upon, the company said.

Each MiraFlex catheter has a hydrophilic coating designed to greatly reduce surface friction, and is engineered with five durometer zones "ranging from a stout proximal portion that delivers improved pushability and control, to a soft, flexible distal tip that reduces the risk of vessel trauma." The FDA cleared the standard MiraFlex catheter in 2006.

UK embraces angioplasty as first treatment

The National Infarct Angioplasty Project (NIAP) final report issued by the UK Department of Health says that primary angioplasty is set to become England's first line of treatment for heart attacks, potentially saving hundreds of lives each year.

The NIAP study has concluded that is both feasible and cost-effective to offer angioplasty as an emergency treatment for 97% of the population.

Currently, thrombolysis, the injection of clot-busting drugs, is the most common treatment for heart attack patients in the UK.

The Department of Health said angioplasty is "widely believed to provide superior outcomes, provided that it can be delivered quickly."

According to the NIAP report, clinical evidence shows that using angioplasty as the main treatment for heart attack patients will:

  • Save around 240 more lives a year.
  • Reduce complications from treatment of heart attack.
  • Reduce reoccurrence of heart attack.
  • Prevent around 260 strokes a year.
  • Decrease the length of stay in hospital for primary angioplasty patients.

The report estimates that 97% of people in England can receive the treatment within acceptable treatment times (120 minutes from call for professional help to delivery of the angioplasty treatment).

Thrombolysis will still be used to treat the 3% or so of patients who would most likely miss the 120-minute window, or who for health reasons couldn't have an angioplasty.

Health Secretary Alan Johnson said, "The national rollout of the primary angioplasty strategy recommended in the NIAP report will save hundreds of lives each year and improve outcomes for many more heart attack patients."

Johnson added that the Department of Health's investment in this study "reinforces its ongoing commitments to tackling cardiovascular heart disease and using clinical evidence to identify the most effective health services. Compared to 1996, nearly 33,000 lives were saved last year in heart disease, stroke and related diseases and inequalities in the death rate from these diseases have been narrowing for the past eight years."

Roger Boyle, national clinical director for heart disease and stroke, said, "As well as providing further evidence of the efficacy of angioplasty, this report shows that a primary angioplasty can be offered to heart attack patients in almost all parts of the country. This is a very positive conclusion in terms of improving outcomes for heart attack patients and ultimately saving lives."

NIAP is an observational study set up by the Department of Health in collaboration with the British Cardiovascular Society and British Cardiovascular Intervention Society.

According to a British Press Association report, the British Heart Foundation welcomed the news, but said the health service must make sure there are sufficient resources to roll out the strategy, which will require extra investment in staff and equipment. "We must not replace a first-class thrombolysis service, which is proven to save lives, with a second-class angioplasty service which might not," the foundation said.

6 hospital teams begin CardioWest training

Heart transplant teams from six new European hospitals began one-week training recently on the SynCardia Companion Driver System while completing the first of four phases of certification training to implant the CardioWest temporary Total Artificial Heart manufactured by SynCardia (Tucson, Arizona).

"With the new Companion Driver, stable CardioWest patients will be able to recover at home while they wait for a matching donor heart," said Bansi Koul, MD, surgical director of heart & lung transplantation and artificial heart & aortic surgery programs at University Hospital Lund in Sweden.

SynCardia said that in Europe, where artificial heart patients can wait up to two years for a matching donor heart, discharge drivers allow stable CardioWest artificial heart recipients to shop, travel, visit friends and enjoy a quality of life comparable to people with healthy human hearts.

The Companion Driver system is designed to eventually replace the current hospital driver known as "Big Blue," which weighs 450 pounds. Patients supported by this driver are confined to the hospital while they wait for a donor heart.

The company also has under development the Freedom driver, which is intended to weigh less than 10 pounds and be carried in a backpack or "fanny pack." It is being designed to power the artificial heart through dual interchangeable batteries to allow even better patient mobility.

The six European hospitals in training bring to 41 the number of centers worldwide to start the certification process to implant the CardioWest artificial heart. They include Universit tsKlinikum Heidelberg (Germany), Ospedale Niguarda Ca'Granda (Milan, Italy), Kerckhoff Klinik (Bad Nauheim, Germany), Centre Hospitalier Universitaire et R gional de Tours (France), Centre Hospitalier Universitaire de Rouen (France) and University Hospital Lund.

SynCardia said it will apply to the FDA during 4Q08 to conduct an IDE clinical study of the Companion Driver in the U.S. and will apply for CE-mark approval in Europe.

Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure.

Meantime, Sweden's first implant of the CardioWest temporary total artificial heart was performed recently at Sahlgrenska University Hospital in Gothenburg.

Ulf Kjellman, MD, head of the ventricular assist device program at Sahlgrenska, implanted the device into a 31-year-old male patient on Oct. 15.

"If it weren't for the CardioWest artificial heart, this patient would have died," said Kjellman. "Both sides of his heart were failing."

The physician added: "He needed a heart transplant to survive, but no donor heart was available. His only option was for us to implant the CardioWest artificial heart as a bridge to transplant."

Mitralign reports first two implants in Europe

Mitralign (Tewksbury, Massachusetts) reported that the first two implants of the Mitralign Percutaneous Annuloplasty System for mitral valve repair in its European pilot study have been performed by Drs. Eberhard Grube and Lutz Buellesfeld at Helios Heart Center (Siegburg, Germany).

The cardiac surgeons, who were assisted by Ralf M ller, MD, said the Mitralign system was able to "significantly reduce" the patient's mitral regurgitation.

The company said the Percutaneous Annuloplasty System "emulates suture mitral annuloplasty surgery without the risk and downside of open-heart surgery." The implant was percutaneously delivered though a single 14 Fr femoral arterial sheath, and provided direct geometric reduction of the posterior annulus. Grube said, "I was pleased with our ability to navigate in the left ventricle and to see mitral valve regurgitation reduced real time with 2-D and 3-D echo."

Mitral valve regurgitation (MR) is common in patients with congestive heart failure (CHF). Mitra-lign said clinical studies have proven that MR "significantly increases the risk of mortality in patients afflicted with CHF, a disease affecting 25 million worldwide."

Mitralign said it is "combining surgical precision with interventional therapy" in developing its catheter-based method to treat mitral regurgitation. The company said its goal "is to emulate the technique employed in traditional open-heart surgery, but in a far less-invasive manner."

FDA okays Austrian firm's product

CNSystems Medizintechnik (Graz, Austria) said it has received FDA clearance for CNSystem's CNAP Monitor 500, permitting the sale of the product in the U.S. The CNAP Monitor 500 measures non-invasive and continuous blood pressure in real-time and can predict responsiveness to fluid administration, according to the company.

In the perioperative setting, detecting blood pressure drops and their cause in time is crucial for peri- and postoperative outcome. However, until recently only invasive methods provided quality information to the clinician.

CNSystems said CNAP provides reliable blood pressure monitoring comparable to invasive techniques and adds valuable information about fluid responsiveness of the patient non-invasively.

It said this allows spreading the highest level of blood pressure monitoring to all perioperative settings where close blood pressure monitoring is indicated, but the risk and discomfort of invasive measurement is not justified.