Vascular Device Forum

Fenestrated Aortic Stent graft extends application in AAA

Science Daily reported the implantation of the Zenith Fenestrated aortic stent graft for the treatment of abdominal aortic aneurysm (AAA) from Cook Endovascular

"In a New York City metro-area first, a 93-year-old Bronx man underwent implantation of a new stent graft at NewYork-Presbyterian Hospital, the only center on the Eastern Seaboard with access to this investigational device. The new stent graft was implanted under an FDA-approved clinical trial protocol. The stent graft is designed to treat a complex form of abdominal aortic aneurysms in which the weakened, enlarged vessel wall is too close to the arteries leading to the kidneys."

"The unique device, known as a fenestrated endograft, is a tubular, fabric graft with supporting metal stents that features custom-positioned holes (fenestrations) that ensure proper blood flow through the aorta and to the kidneys and nearby organs."

The Advanced Medical Technology Association, whose members include Medtronic Inc. (nyse: MDT - news - people ) and Boston Scientific Corp. (nyse: BSX - news - people ), lobbied on legislation affecting the regulation of devices by the Food and Drug Administration and payments for technology by Medicare.

The medical device industry's chief advocacy group spent $924,074 lobbying the federal government in the second quarter of the year, according to a recent disclosure report.

How do we identify the vulnerable Plaque

One of vascular imagings largest obstacles is identification of the vulnerable plaque. Unfortunately the current gold standard of imaging, digital angiography is largely anatomic in its value. Not physiologic. The ideal modality would allow us to detect the plaque that has characteristics that are identified to be closely associated with plaque rupture. Plaque rupture is the event which typicall leads to vessel occlusion and acute ischemia in the brain or heart. The event usually involves rupture of unstable lipid-laden material which is followed by platelet aggregation and in severe case, thrombus adherence. If one is lucky, the entire lumen of the blood veseel is not completely occluded.

Various modalities like ultrasound have identified characteristics of plaques that are more consistent with embolization like heterogenicity. Cardiac Interventions Today presents a review article discussing current investigational modalities in this important area of plaque characterization

Source

Innovations in vascular access closure device technology

In our review of monthly journals we came across a fantastic overview of vascular closure devices in Cardiac Interventions Today. Vascular Access Closure remains a challenging and under appreciated aspect of percutaneous interventions.  Effective access technology decreases procedural morbidity and facilitates early discharge.

Zoltan G Turi presents on overview of available device technologies.....

Save this table for reference

Cordis Outback Re entry device for Chronic Total Occlusion Recalled

This just in. I was doing an endovascular case today in a patient with a chronic total occlusion (CTO)  of the femoral artery. After crossing the total occlusion, I needed to re enter the true lumen after being unsuccefful with my glide wire (Terumo) and Quik Cross (Spectranetics). I called for my "go to tool" which is my device of choice for me in this cirumstance. Only to find out that Cordis Endovascular/Johnson and Johnson has pulled the Outback re entry device from the market. More information will be forthcoming, however it appears that this is a proactive voluntary recall because of a .27% incidence of failure of the piercing needle component to safely retract. I'll corroberate that information in future posts.

The description of the event that triggered the recall was previously described in an FDA post in March, 2007.

For more information about chronic total occlusion (CTO) and methods of intervening upon these challenging lesions read this review article at vascular disease management.

The question that arises is will this affect level of success for CTO treatment because this is a commonly used device or will alternative devices such as the Pioneer device (Medtronic Vascular) fill the void.

State of the Industry Report for industry experts-Important reference

Medical Device Daily State of the Industry Report 2008

The industry's most comprehensive annual report on med-tech sectors, companies and products.

With the Medical Device Daily State of the Industry Report 2008, you will be able to:

• Get a competitive overview of each market!
• View financial benchmarks and trends in the industry: IPOs, dealmaking, M&As, VC investments, etc.!
• Understand how certain FDA movements will affect the industry in 2008 and beyond!
• Find potential partners, licensing and marketing opportunities!

Published by Medical Device Daily, the newspaper of record for the med-tech industry, the Medical Device Daily State of the Industry Report 2008 is the "reference of choice" used by executives, investors and analysts to understand where the med-tech industry is heading, which sectors are rising and declining, and what opportunities lay ahead. This industry report covers company financial data, product development, sector trends and more!

The first half of the report offers a generous overview of the industry, with a variety of perspectives on the financial markets, dealmakers and Washington, including legislative/regulatory outlooks for the FDA and reimbursement issues for CMS

Individual market sectors covered in this report include:

• Cardiovascular
• Clinical diagnostics and imaging
• Orthopedics
• Biomaterials
• Surgical/anesthesia/monitoring
• Healthcare IT
• Neurology
• Interventional radiology
• Genetics/stem cells
• Oncology
• Urology
• Ophthalmology
• Diabetes/obesity
• Women's health

HeartWare (Farmingham, Massachusetts/Sydney, Australia) said that the first U.S. patient has received its HeartWare Left Ventricular Assist System (LVAS) at Washington Hospital Center (WHC; Washington), which marks the start of HeartWare's U.S. bridge-to-transplant clinical trial. Steven Boyce, MD, surgical director of the heart failure program at WHC, performed the surgery.

"Of course we think it's the best thing in the world, but we're a little biased," HeartWare's President/CEO Doug Godshall said, before telling Medical Device Daily what sets the HeartWare LVAS apart from others on the market. "What physicians seem to like about our product is it is a particularly small pump, about 50 ccs."

The pump is small enough to fit in the pericardial space adjacent to the heart, Godshall said, which avoids any abdominal surgery and having to create a pump pocket, which sometimes leads to infections. In the company's international trial of the product there have not been any implant infections, he added.

Other companies developing similar devices include Ventracor (Chatswood, Australia), Abiomed (Danvers, Massachusetts) and Thoratec (Pleasanton, California).

Ventracor offers the VentraAssist, a VAD that operates on a hemodynamically-suspended titanium impeller. The VentraAssist has a CE mark, and is currently enrolling patients in a U.S. pivotal trial (MDD, Sept. 19, 2007).

Abiomed makes the Impella 2.5, which installs percutaneously and straddles the aortic valve to drive blood from the left ventricle to the left atrium. In June, Abiomed received 510(k) clearance from the FDA for the Impella 2.5 as a circulatory support tool that interventionalists can use to increase blood flow to the heart muscle and vital organs. The company is also studying the device as an LVAD for heart attack patients (MDD, June 3, 2008).

Thoratec won an approvable recommendation with conditions from the circulatory systems advisory panel of the FDA late last year for its HeartMate II, the newest generation of the HeartMate LVAD.

Source

New Left Ventricular assist System from Terumo Medical

Terumo Heart, Inc. today announced the discharge of the first U.S. patient implanted with the DuraHeart(TM) Left Ventricular Assist System (LVAS). The patient was discharged home on August 14th, from the University of Michigan Health System, 15 days after receiving the device.

The patient is a 62-year-old man from Livonia, Michigan, who has been suffering from heart failure for nearly 20 years. He is the first U.S. patient to receive a ventricular assist system that utilizes advanced magnetic levitation (Mag-Lev), a new, innovative type of technology.

Dr Pagani, National Co-Principal Investigator for the U.S. pivotal trial of the DuraHeart LVAS commented on the recent discharge. "We are extremely pleased with the performance of the DuraHeart and the recovery of our patient to an excellent functional state to permit discharge. We look forward to expanding upon our early experience with the DuraHeart in the near future."

The goal of these devices is to return the patient back to a relatively normal lifestyle and to provide improved "quality of life." "We are delighted that the FDA has allowed us to begin this trial with no restriction on patient discharge, which has not been true of some of the other devices currently conducting Trials in the United States," said Chisato Nojiri, M.D., PhD, Chief Executive Officer for Terumo Heart, Inc.

Earlier generation Left Ventricular Assist devices are prone to hemolysis, blood clots and mechanical failure. Significant advances have been made in the DuraHeart LVAS to potentially overcome these problems. Dr. Nojiri explained: "We have a unique pump design that combines advanced "Mag-Lev" technology and a centrifugal pump. The "Mag-Lev" allows for the complete elimination of mechanical contact within the blood flow path, minimizing the chance of mechanical failure. This is expected to significantly improve the clinical performance and long-term potential of this type of therapy." It has been used in more than 70 patients in Europe with the longest ongoing support over 3 years.

The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular failure. The National Co-Principal Investigators are Francis Pagani, M.D., Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York.

Source

Diamondback from CSI recognized as one of the "Top ten Innovations in Podiatric Care"

At VDF we focus our efforts on providing up-to-date information about the rapidly evolving cardiovascular device field. We focus on topics like device innovation but we also like to discuss corporate issues from the struggles of the small start up to the efforts of the industry behemoths hell bent on pleasing the street and providing shareholder value.

Occasionally, we like to profile some of the areas of medicine tangentially affected by cardiovascular innovation. Podiatry represents one of the niche areas. At my institution, our practice has always maintained a very close relationship with our Podiatrists. We maintain a woundcare facility and we encounter a lot of PAD, diabetic ulceration patients.  Diligent wound care is a must to successfully treat this challenging patient group.

I recently posted on a new tool in the endovascular "tool box", The Diamondback Orbital Atherectomy system from CSI. The device was referred to as one of the "Top ten Innovations in Podiatric Care" recently. Foxhollow made a strong push to market directly to podiatrists in an effort to reach the first line of care for many PAD patients with the admonishment that all podiatrists should send their patients to a Silverhawk Atherectomy performing interventionalist. In many cases they were successful and for proceduralists using this technology, the assistance was welcome. They were quite successful in making the Silverhawk from Foxhollow one of the darlings of Podiatrists everywher.  I dont know if CSI will take the same approach, but is was somewhat effective. I still get call from docs that ask, "are you silverhawking my patient" ?

New Innovation in Coronary Bare Metal Stent technology

As the controversy regarding drug eluting stent technology evolves, innovations in bare-stent technology are timely

Today, OrbusNeich announced plans to hire 150-200 new employees in the US over the next two years. OrbusNeich is a maker of innovative bare metal stent technology. The Hong Kong based company, which has its US based facility in Fort Lauderdale, needs to develop clinical and research teams to begin its US based research trials. OrbusNeich's stent, known as the blazer, is already available in Europe, the middle east and South America.

If all goes well, the trial which would follow patients for about nine months would produce results by 2010. The trial will be performed at a cost of $5-10 million.

Stephen Dunn, director of research at Boca Raton-based Dawson James Securities, said the health concerns raised about drug-eluting stents in clinical trials has opened the door for bare metal stents to grab a larger piece of the market. Bare metal stents also cost less, making them preferred by the insurance industry and government health programs, Dunn added.

OrbusNeich is also working on a hybrid stent. It would have the antibodies on the inside and a drug coating outside. That one is in development in Fort Lauderdale.

In order to fund a U.S. clinical trial for the Genous or the hybrid stent, OrbusNeich is considering a public offering in the U.S., Camp said. Other options include a private equity investment or a partnership with a larger corporation.

Source

Medical Device Investor day prior to IN3E (Investment in Innovation)

Vascular Device Forum (VDF) is excited about the upcoming Medical Device Investor day that is scheduled to precede Investement In Innovation East (IN3E). Held in Boston, this years IN3 event is billed

"As the largest East Coast strategic partnership and investment meeting for senior-level medical technology executives, hundreds of venture capital companies and medical technology companies gather each year to hear about the latest innovations and investment opportunities"

Specifically, the event features members of industry from:

Cardiovascular/Interventional Cardiology

Diagnostics

Drug Delivery

Imaging

Minimally Invasive Surgery

Nanotechnology

Neurostimulation

Orthopedics/Spine

Peripheral Vascular

Stem Cells

Stroke Management

Wound Management

Medical Device Investor Day occurs Oct 22, 2008,  prior to Investment In Innovation program. This is scheduled to be a full day of presentations by some of the most influential companies in the medical device space. Invited presenters include: Johnson & Johnson, Boston Scientific, Covidien, Abbott, Medtronic, Stryker, Zimmer, Edwards Lifesciences, Phillips Medical, BD, Hologic, GE, Baxter, St. Jude Medical, Biomet, and many others

Sample Agenda:

8:30-9:30 a.m.

Keynote Panel Discussion

Stories behind How Financing Deals got Done
• Why we invested in certain technologies/clinical spaces

• What kind of due diligence got done

• How valuations were determined

• What was the rationale behind the deal from an in investment point of view

Panelists:
David Milne, Managing Partner, SV Life Science Advisers LP
Kevin Connors, General Partner, Spray Venture Partners
Amir Nashat, General Partner, Polaris Ventures