Vascular Device Forum

Bad news for Marine Polymer Technologies?

I recently blogged on what I feel is a promising new hemostasis agent from Marine Polymer Technologies, the Syvek Patch. We have used the patch and it has performed well as a leave nothing behind agent to achieve puncture site hemostasis-most commonly at the femoral artery.

From MSN:

Vascular Solutions, Inc. (Nasdaq:VASC) announced that the First Circuit of the U.S. Court of Appeals has affirmed the judgment in its favor in its product disparagement litigation with Marine Polymer Technologies...

This appears to be bad news for a small publicly held company. 

Cook Medical’s Spectrum Turbo-Ject PICC diminishes life threatening catheter infections

 As healthcare reform continues, medical technologies that diminish healthcare costs will ultimately become the disruptive technologies that revolutionize the way that we practice medicine and improve patient outcomes.  Companies that create these technologies will become industry leaders, others will perish.  Below is a press release from Cook Medicals Turbo Ject PICC

 

 

Ability to Reduce Risk of 250,000 Potentially Fatal Hospital Acquired Infections Sparks Sales of Cook Medical’s Spectrum Turbo-Ject PICC

 

Demand from major US healthcare institutions demonstrates industry recognition of need for advanced products to prevent dangerous bloodstream infections

Bloomington, Ind. – July 7, 2009 – Interventional radiologists are increasingly adopting Cook Medical’s Spectrum Turbo-Ject PICC to prevent the occurrence of potentially fatal catheter related blood stream infections (CRBSIs) and stem the high cost of related treatment. Since the launch of the product in April, Spectrum Turbo-Ject PICC has sold 2,500 Spectrum Turbo-Ject PICC units to more than 70 institutions across the country. This rapid sales growth is attributed greatly to Spectrum Turbo-Ject PICC’s ability to help reduce the risk of potentially fatal CRBSIs that the Centers for Disease Control report cause about 250,000 deaths in the U.S. annually. 

With the Centers for Medicare and Medicaid Services (CMS) changing the rules for reimbursing hospitals for the treatment costs associated with CRBSIs and other HAIs, the industry is fast recognizing the need to use advanced technologies to reduce the risk of these infections. Used in tandem with comprehensive hygiene protocols, advanced technologies like the Spectrum Turbo-Ject PICC, may help to improve patient quality care.

“Quality patient care is top priority at McKay-Dee Hospital Center,” said Todd Sanford, R.N. from the Interventional Radiology department at McKay-Dee Hospital Center, a member of the Intermountain Healthcare system. “We are pleased to learn of the ability of the Spectrum technology on PICCs with power-injectable capabilities. The Spectrum Turbo-Ject PICC is another tool to provide our patients with the best possible care.”

The first power injectable antibiotic-impregnated peripherally inserted central venous catheter (PICC), the Spectrum Turbo-Ject PICC is capable of accepting the contrast media injection rates required for CT scans. The ability to power-inject contrast media, combined with the Spectrum technology’s proven ability to establish a clinically significant zone of inhibition against the organisms most frequently associated with CRBSIs, means that patients receiving PICC lines will face reduced risk from deadly CRBSIs, while clinicians will have access to flow rates that are among the industry’s highest^[1].

“The Spectrum Turbo-Ject PICC has set the industry standard for safeguarding against potentially deadly CRBSIs,” said Dan Sirota, global business leader of Cook Medical’s interventional radiology business unit. “Cook is pleased with this tremendous rate of adoption and looks forward to continuing its relationship with the interventional radiology community and providing the best solutions to improve patient care.”

According to the Center for Disease Control, Costs associated with treating these infections average $34,508 to $56,000 each, making CRBSI prevention a major health care cost reduction issue, especially with rising treatment costs and Medicare non-reimbursement. Additionally, about 30,000 U.S. patients die each year from these systemic infections that have been deemed to be largely preventable.  Numerous peer-reviewed publications, including a landmark study published in the New England Journal of Medicine, have demonstrated both the safety and superior efficacy of the minocycline and rifampin Spectrum technology.  Spectrum technology has been shown to establish zones of inhibition greater than 15 mm for up to 63 days against the leading causes of CRBSIs.

The combination of the antibiotics minocycline and rifampin that are impregnated within the material of the Cook Spectrum catheters work synergistically to provide broad-spectrum protection against the leading causes of CRBSI, including MRSA, VRSA, and VRE are in both short- and long-term applications. Unlike most systemic antibiotics, this unique combination has the ability to penetrate the biofilm that forms on all indwelling catheters. Additionally, research has conclusively shown that use of these catheters does not promote the growth of antibiotic-resistant strains of bacteria in patients receiving Spectrum catheters. In fact, the use of Spectrum technology has demonstrated reduced antibiotic-resistant strains in one single-center study^[2].

 

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

Cook Medical and Spectrum Technology in PICC Lines

We love breaking news of new disruptive vascular technology at VDF.com and Cook Medical appears to have one here. I spoke to the folks at Cook Medical (Bloomington IN) and they are very optimistic about the impact that this technology will have on patient outcomes.

 

Hospital acquired catheter infections in PICC lines are a significant concern both in terms of patient outcomes as well as healthcare cost considerations. Vascular line infections, considered an avoidable complication by the CMS as a result of the DRA, will be monitored closely by all healthcare facilities.

 

Industry studies suggest that there are approximately 3 million peripherally inserted central lines with an infection rate ranging from 4-7%. Factors associated with line infection include duration of use, patient comorbidities and insertion technique.

 

Current "anti septic" picc lines provide infection resistance for 4-5 days. New spectrum technology demonstrated zones of inhibition for approximately 63 days. This technology appears to represent a significant advance and a relatively underappreciated sector of patient care. If post release studies confirm these results, the technology will provide significant savings to healthcare.

 

Consider all of the pipeline applications for the use of this technology.

      Cook Medical Launches Spectrum Turbo-Ject Antibiotic PICC

May 11, 2009—Cook Medical (Bloomington, IN) announced the launch of the Spectrum Turbo-Ject percutaneously inserted central venous catheter (PICC). The Spectrum Turbo-Ject is an antibiotic-impregnated pressure injection PICC that is capable of accepting the contrast media injection rates required for CT scans while protecting against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject PICC is being offered in multiple catheter configurations with a range of flow rates to meet patients' needs. The device's features include maximum pressure-limit settings of 325 psi, 5-F single and double lumen with maximum flow rates of 7 and 5 mL/s, respectively, 4-F single lumen with a maximum flow rate of 4 mL/s, and 50- and 60-cm lengths. Additionally, Cook Medical is offering its PICC procedural tray, designed to efficiently supply the essential components for a clinician placing a PICC, whether bedside or in an interventional radiology lab. The tray provides the vital components for maximal sterile barrier precautions, which is a significant part of patient safety and infection control, the company stated.

According to Cook Medical, Spectrum technology has been shown to establish zones of inhibition > 15 mm for up to 63 days against the leading cause of CRBSIs. The combination of the antibiotics minocycline and rifampin that are impregnated within the material of the catheters provide broad-spectrum protection against gram positive, gram negative, and fungal organisms in both short- and long-term use. This combination has the ability to penetrate the biofilm that forms on all indwelling catheters while not promoting the growth of antibiotic-resistant strains of bacteria in patients receiving the catheters. The company noted that in October 2008, the Centers for Medicare & Medicaid Services eliminated reimbursement to hospitals for treating CRBSIs and other hospital-acquired infections.

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.

Diamondback from CSI-Niche useless device or Toolbox Asset

For those of you who have entered the world of athrectomy/atherectomy you might be following the trajectory of CSI(Cardiovascular Systems Inc) which was ramping up to conduct an IPO. Information surfaced in early November 2008 that due to the challenging economic conditions and the IPO drought, they would merge with a struggling existing publicly traded company Replidyne. By reports, Replidyne is essentially a shell company with no products, no revenue and very few employees. What they do have is a Nasdaq listing and a ticker symbol.

Over the past few months, IPOs have ground to a halt, forcing companies to either postpone or pull their stock debuts altogether. In the first nine months of this year, 77 companies withdrew their IPOs, 19 in the third quarter alone, according to Bloomberg News. Through September, just 55 companies have gone public, down from 226 during the same period in 2007.

Getting creative

Im interested to get some feedback on this device. We know that the Silverhawk formerly of Foxhollow and now EV3 fame had limitations such as an inability to treat vessel calcification. The initial company push for the Diamondback is for the treatment of calcific athero-occlusive disease. I have successfully used it in densely calcified infra popliteal vessels. The question becomes, depending upon ones population, is the presence of segmentally, calcified infra pop disease so infrequent as to make the indicated use for this device relatively few and far between. I have used it on minimally calcified vessels with underwhelming results as one would expect  based upon its theoretical mechanism of action which is atherectomy of calcific, non compliant tissue.

The major cost associated with the device include multiple catheter sizes and a couple of different crown types for various disease levels. To date, my impression is that a lot of enthusiasm for this device is in the interventional cardiology space. I feel that durable results with minimally invasive technology is really limited to focal tibial level disease with good run off. Unfortunately, many of the diabetic and renal insufficiency patients with dense calcific vessel disease have an extremely diffuse pattern. And in the circumstance when there is significant tissue loss, I personally feel that direct pulsatile flow to the area of tissue loss is the most reliable means of salvaging the limb if adequate conduit is available. Furthermore, products like the propaten graft from Gore Medical and the Venaflo from CR Bard offer reasonable alternatives to spliced vein autologous vessel bypass.

Bottom line, is that I would like to get a some feedback on what others are experiencing in their practice with the use of this technology.

Chronic Total Occlusion-optoons

The voluntary withdrawal of the Outback Re-entry device from the vascular device market by Cordis Vascular (Johnson and Johnson) has left a void in the tool box with regards to the treatment of long segment total occlusive lesions of the femoral popliteal segment. I found an interesting article recently reviewing the FDA approved options. click here

Vascular Device Forum welcomes submission on tips about recanalizing CTO lesions.

Drug Eluting Stent Taxus fails to show superiority

From the European desk of Medical Device Daily, the results of the Syntax Study presented at the congress of the European Society of Cardiology has left cardiologists scratching their heads and stent manufacturers searching for a believable spin. In the end, the Syntax Study failed to show non-inferiority for DES (Drug Eluting Stents) vs open Coronary revascularization.

The study involved the Taxus stent from Boston Scientific with a primary endpoint of death, stroke or myocardial infarction

Source

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.