Vascular Device Forum

Conflicts of interest attract Senate attention

This is a story that has been circling for some time. Although it involves an orthopedic surgeon. The topic is germaine to all medical fields. It involves  the issue of industry support, especially with regards to ghost writing and industry supported research. Dr Tim Kuklo is the orthopedic surgeon at the center is this turmoil. He previously worked at Walter Reed and has been on faculty at Wash U. The company allegedly providing the support is Medtronic

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Vascular Closure Device New Generation Mynx

Endovascular Today reports the early results of the Mynx Closure Device. Closure technology is advancing with the "leave nothing behind" philosophy driving innovation. The Mynx® Vascular Closure Device Adopting extravascular closure technology in the catheterization lab. By Ameer Kabour, MD, FACC, FSCAI, and E. Dean Nukta, MD, Facp, FACC, FSCAI Can an extravascular sealant technology really do the job even in highly anticoagulated interventional procedures? The Mynx experience thus far suggests that it can. Early experience indicates that Mynx is effective in achieving immediate and durable hemostasis as evidenced by comparable outcomes in both diagnostic and interventional catheterization procedures. In our experience, Mynx has proven to be a clinically versatile closure technology that is suitable even in procedures in which peripheral disease, obesity, and bifurcation anatomy pose challenges with regard to arteriotomy access and closure. The most appealing features of the Mynx Vascular Closure Device are the complete lack of intraluminal components, the elegant and easily mastered deployment, and the virtual absence of patient discomfort. ■ Source

Catheter Associated Infection- A never event Part I

Unless you haven't been at a staff meeting recently, you are probably well aware of the term "never event". A term used to describe a set of clinical outcomes that are designated as being avoidable hospital events. Pertinent to the vascular device community is the inclusion of vascular catheter infections. Vascular catheters and their respective uses are quite familiar to interventional radiologists, vascular surgeons, interventional nephrologists and cardiologists.

In our market economy, identified problems frequently present an opportunity for innovation. Innovation in catheter design will no doubt address some of these infection control dilemmas. Additionally, it will be interesting to follow the process of monitoring catheter infections in non hospital based settings. Today's post is an informative introduction of the background to the DRA of 2005. We'll follow up with a post on specific technology

The Issue

On February 8, 2006, President Bush signed the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA) which contained language[1] creating a system for quality adjustment of Medicare payments for inpatient hospital services. The law required the Secretary of Health and Human Services (HHS) to identify at least two hospital-acquired conditions which could have reasonably been avoided through the application of evidence based guidelines and would be subject to the adjustment in payment.

Background

 

The rate of growth in health care costs has made it necessary for payers of health care services to examine every avenue available to conserve health care dollars. According to the Congressional Budget Office (CBO), without any changes to federal law, total spending on health care will rise from 16 percent of the gross domestic product (GDP) in 2007 to 25 percent in 2025 and 49 percent in 2082, and net federal spending on Medicare and Medicaid will rise from four percent of the GDP to almost 20 percent over the same period. CBO sites inefficiency in the health care system as a principle variable contributing to the increased cost. They support this notion through an examination of the variation in health care cost across the country yet noting that the quality in health care is less variable.

The Institute of Medicine has estimated that medical errors cost $17 billion to $29 billion per year with most of the cost being shifted to outside payers such as Medicare. Research conducted by the Harvard School of Public Health[2] in 2006 found after examination of 14,732 discharge records from 24 hospitals in Colorado and Utah, the average cost per injury was $58,766 for all adverse events and $113,280 for negligent injury. They also concluded that 78 percent of the costs associated with all injuries were externalized to outside payers and 70 percent of costs associated with negligent injuries.

Federal Actions

Taking these factors into consideration, the DRA required CMS to select at least two hospital-acquired conditions that would be subject to a quality payment adjustment. CMS consulted with the Centers for Disease Control and Prevention (CDC) to identify the conditions proposed for reduced payment in FY 2009 and additional conditions that would be considered for reduced payment in subsequent years. The conditions were selected from a list of "never events" or conditions which had been identified by the National Quality Forum[3] in 2002. "Never events" are serious reportable events, which should never have happened and could have been prevented[4]. Specific criteria for selection of the conditions were provided as follows:

1. The condition must be associated with a high cost of treatment or high occurrence rates within hospital settings.
2. The condition results in higher payment to the facility when submitted as a secondary diagnosis.
3. The condition can reasonably be prevented by adoption and implementation of evidence-based guidelines.

Selected Conditions The first eight conditions, which were selected last year because they greatly complicate the treatment of the illness or injury that caused the hospitalization, resulting in higher payments to the hospital for the patient's care by both Medicare and the patient were: Object inadvertently left in after surgery Air embolism Blood incompatibility Catheter associated urinary tract infection Pressure ulcer (decubitus ulcer) Vascular catheter associated infection Surgical site infection-Mediastinitis (infection in the chest) after coronary artery bypass graft surgery Certain types of falls and traumas 2008 Additions Surgical site infections following certain elective procedures, including certain orthopedic surgeries, and bariatric surgery for obesity Certain manifestations of poor control of blood sugar levels Deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures.

Zilver PTX effective in treating SFA occlusions

 Cook Medical  and Angiotech Pharmaceuticals recently announced 2 year follow up for the Zilver PTX drug eluting (Palcitaxel) stent in the superficial femoral artery. The trial is created to assess the safety and effectiveness in treating PAD. Safety and effectiveness have previously been determined iin the coronary circulation only to be followed subsequently by concerns of acute thromboses which occurred at a higher rate relative to bare metal stents.

Paclitaxel, an anti-neoplastict agent, has shown a significant benefit in reducing in stent re-stenosis, the "achilles heal" of percutaneous stenting. Previous trials have shown questionable benefit of drug eluting stent technology in the infra inguinal circulation.

– Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today

announced its corporate partner, Cook Medical, reported data on two-year follow up that showed that 82

percent of patients who were treated with Cook Medical's Zilver® PTX™ drug-eluting peripheral stent (DES)

were free from reintervention at two-year follow up. The Zilver PTX Registry study, involving 792 patients

from across the world, is assessing the safety and efficacy of the Zilver PTX in treating PAD. The most recent

results were reported at the 31st International Symposium: Charing Cross Controversies Challenges Consensus.

“These results are extremely encouraging as it's the first time paclitaxel-coated stents have been used in the

treatment of blockages in arteries outside the heart,” said Zilver PTX global principal investigator, Dr. Michael

Dake, Professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and

Medical Director of the Cath/Angio Laboratories at Stanford University Medical Center. “Patients treated with

the Zilver PTX had a very low complication rate and required fewer reinterventions.”

Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively from the registry study,

which enrolled a broad spectrum of patients, including those with complex lesions (e.g., long lesions, total

occlusions, in-stent restenosis). The corresponding event-free survival (EFS) rates were 87 percent and 78

percent, and freedom from TLR (target lesion revascularization) was 89 percent and 82 percent. Clinical

measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed

significant improvement at six and 12 months and were maintained through 24 months.

Detailed evaluation of stent x-rays demonstrated excellent stent integrity through 12 months, confirming

previously published results showing 99 percent completely intact stents with a mean follow up of 2.4 years in

the challenging superior femoral artery and popliteal arteries, including behind the knee locations.

One in five in the 65- to 75-year-old age group in the UK* has peripheral arterial disease (PAD). Yet only a

quarter of these people have any symptoms at all. The 'silent' nature of this condition can result in a number of

patients being diagnosed only when their condition has progressed to the severe stage. In patients with severe

PAD whose condition is not improving with risk-factor modification, exercise programs and pharmacological

therapy, invasive procedures may need to be carried out. These procedures include angioplasty, stenting or

surgery.

“We are impressed with both the efficacy and durability demonstrated by the Zilver PTX in the registry study

and believe we will see similar results in the US randomized trial which is currently ongoing,” said Dr. Bill

Hunter, President and CEO of Angiotech. “Our partner, Cook Medical, has been committed to continually

improving the efficacy and safety of peripheral DES and early results suggest that the self-expanding, Zilver

PTX stent will be an important treatment option for patients with PAD.”

In addition to the registry arm of the study, the 480 patient randomized component is designed to evaluate the

Zilver PTX across 45 trial sites in the United States, Japan and Europe. Of the 480 patients enrolled in the

randomized study, 240 received the Zilver PTX DES. Enrollment in the randomized study was completed in

2008. For more information, please visit www.zilverptxtrial.com.

Aptus Staple 2 device for EVAR-Another Hurdle Crossed

Endovascular Today announced the recent completion of the Aptus II study primary enrollment.This is the US study to demonstate safety and effectiveness of the Aptus stapling system from Aptus Endosystems, Inc (Sunnyvale, CA).  The device is an aortic endograft system that incorporates the companies proprietary stapling system.

This device will cross another hurdle that has been a long standing differentiating feature of open versus EVAR. Stable proximal fixation, especially in adverse proximal aortic neck anatomy.

The investigators enrolled 155 sequential patients across 25 US clinical trial sites as part of the study to assess the perioperative and long-term performance of the company's combination of stent graft and endovascular stapling system in the treatment of AAA. Patients enrolled in the study are subject to 1-, 6-, and 12-month follow-up reviews. The company will then submit data to the Food and Drug Administration (FDA) for review under the premarket approval process. The company intends to submit its final data module to the FDA early next year. Ronald Fairman, MD, and Manish Mehta, MD, are national coprincipal investigators for the STAPLE-2 study.

The company stated that STAPLE-1, the phase 1 study that enrolled 21 patients at five US institutions, produced positive clinical outcomes, which were presented in November 2008 at the VEITH Symposium in New York City. These study results showed no device-related endoleaks (type I, III, or IV) and no device migration as late as 2 years postprocedure for those patients who had reached that follow-up. Additionally, more than 90% of patients demonstrated a clinically significant reduction in their aneurysm size as early as 6 months postprocedure.

"The 1-year follow-up outcome data is particularly robust and impressive," commented Dr. Fairman. "The completion of the pivotal STAPLE-2 study brings the therapy to a new level. This truly novel concept of active proximal fixation using helical Ôscrews' combined with a modular endograft on a very small, flexible delivery system expands the option for endovascular therapy to a greater pool of patients."

"This endovascular stapling technology facilitates our ability to perform aneurysm repair in a manner that closely approximates the suturing technique that is the foundation of open surgical repair," added Dr. Mehta. "Having the ability to separately control the fixation of the endograft in a catheter-based technology is a new and clinically important capability relative to improved outcomes for patients."

 

New Guidelines recommend thrombolysis for Proximal DVT

Dr Santiago Chahwan from the Naples Florida Vascular Group posted previously on his extensive experience with pharmaco-mechanical thrombolysis of ilio femoral deep venous thromboses using the trellis-8 device from Bacchus Vascular. Successful thrombolysis improves patient outcomes when the endpoints of limb function, symptom severity and post thrombotic syndrome are assessed.

The newly-published 2008 clinical guidelines for physicians from the American College of Chest Physicians (ACCP) on how to treat DVT and other forms of venous thromboembolic disease now recommend pharmacomechanical thrombolysis for treatment of acute proximal DVT. The guidelines are available as a complimentary download at:

http://www.thenewguidelines.org

Hopefully, this will encourage our medical colleagues to accept pharmacomechanical thrombolysis as the treatment of choice in the appropriately selected candidate patients. This validates the management strategy, however I still think there are quite a few institutions that do not utilize this option sufficiently in this large group of patients.

Cook begins peripheral drug eluting stent trial

Cook Medical of Bloomington Indiana has completed enrollment in a clinical trial to assess the outcomes of drug eluting stents in the peripheral circulation. This places Cook at the forefront of peripheral device companies poised to bring drug elutin stent technology to the peripheral circulation. The trial of the ZilverPTX (zilverPTXtrial.com) uses paclitaxel coated nitinol stents to treat the SFA.

Cook has licensed the right to use a proprietary technology which binds the drug to the stent without the assistance of a polymer which may theoretically lessen the risk of allergic reaction.

Michael Dake MD, Professor of Radiology at University of Virginia health system is the primary investigator for the study and the results were released at SVS 2008

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

Top Ten Cardiovascular and Peripheral Vascular Early stage companies

Vascular Device Forum (VDF) cites an article in Medical Device Today which describes the top ten early stage Cardiovascular and Vascular companies. This list was created from presentations at the "Investment In Innovation (In3) Medical Device Summit" on June 17-19, 2008. (Part 1 of 3)

1) Arterial Remodeling Technologies tops the list. Arterial Remodeling Technologies (“ART”) is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. Many industry experts are calling ART the next best thing.

2) CardiAQ Valve Technologies

3) ES Vascular technologies develops vascular staplers for open, endovascular AAA and femoral popliteal reconstructions.

7) Protomed creates sutureless techniques to facilitate rapid and safe completion of vascular anastomosis

Wall Street Journal challenges Boston Scientific's data on Taxus

Reuters reports that The Wall Street Journal is challenging the validity of data that Boston Scientific has submitted to the FDA for approval of it Taxus Liberte coronary stent system. The study was completed in 2006.

The Wall Street Journal suggests that the analysis of the data is statistically flawed due to the use of an equation called the Wald interval. WSJ states that using various off the shelf statistical analysis software systems to process the data would yield unfavorable results. The equation, used by other companies in similar studies like Medtronic and Abbott Vascular, would not have resulted in negative outcomes for these respective companies.

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