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

See the complete story

Malpractice issues in vascular device use

endovascular repair, is the physician expected to

relate complications of a specific device, or just

those of endovascular repair in general?

Ms. Rode:

If the specific risks associated with a particular

device are recognized in the medical literature and

acknowledged to have significant incidence rate, then the

patient should be informed. For instance, if there is a procedure

in which two devices may be used, and the

devices carry different risks, the patient needs to be

informed of the risks associated with both devices and

consent to it (eg, in hip-replacement cases or other cases

in which the choice of two devices is determined intraoperatively,

the patient needs to know that device selection

will take place during the procedure, and—if the risk

associated with each device differs—the risks associated

with each device).

Ms. Rode:

However, you should be prepared for the

added sex appeal of the “investigatory/guinea pig” spin

that the plaintiff’s counsel will use to inflate the

verdict/settlement value of a case involving off-label

products. Insurance carriers take that factor very seriously

in evaluating cases involving off-label devices, institutional

review board protocol, etc.

Given the different types of endografts used in

Instructions for Use (IFU). I always notify the

patients and family of this and note that the

patient may be at increased risk of short- and

long-term adverse events as a result of this. If

adverse events do occur, what is my liability?

I received very positive feedback on a previous post discussing basic medical malpractice considerations. So I thought it might be helpful to discuss some examples of medical malpractice considerations specific to vascular devices. This goes without saying, but consult an attorney in your state as laws very from state to state and this should not be perceived as legal advice.

Are we obligated to tell patients that some

peripheral stenting is not approved by the FDA

even though it is done very commonly?

Requirements regarding the disclosure of

off-label uses likely vary by state. In Pennsylvania, a physician

is under no obligation to advise a patient of the FDA

status of a medical device (eg, Southard v. Temple Univ.

Hosp., 781 A.2d 101 [Pa. 2001]). The law in your state

may vary and on this important topic, and you should

consult with local counsel.

I use many products off-label and outside of the

This will usually fall under the “standard of

care” discussion. If what you do falls under the accepted

“standard of care,” it should not expose the surgeon to

increased liability.

source

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].

 

Literature summary Silverhawk, Diamondback and Jetstream G2 devices

The major criticism of peripheral atherectomy continues to be "show me the data". The device companies counter with "we gave you what was necessary for approval... anything else is too expensive". EV3 has threatened that further studies are forthcoming. Until then, EVToday has a nice review article from Husami, Akhter and Lawrence Garcia at St Elizabeths in Boston.

Atherectomy in the Superficial Femoral Artery
An evidence-based approach for device selection, ideal applications, and cases to avoid.
By Wael F. Al-Husami, MD, FACC; Mohammed W. Akhter, MD; and Lawrence A. Garcia, MD, FACC, FAHA

Currently, there are multiple treatment strategies to address stenotic or occlusive atherosclerotic disease in the superficial femoral artery (SFA). Percutaneous transluminal angioplasty (PTA) results have traditionally been suboptimal and less durable, especially with longer-lesion subsets.^1,2 Self-expanding nitinol stents do not perform as well when considering long-term patency rates (after 2 years) based on recently published stent trials, even though they are accepted as the default therapy for treating the SFA.^3-5

Atherectomy in the peripheral vasculature has gained interest due to its perceived benefits over simple PTA. The theoretical avoidance of barotrauma and overstretch of the vessel wall is desirable and can prevent acute vessel recoil or dissection. These unwanted side effects can lead to restenosis or reocclusion in the treated vessel. However, it is unclear how often stand-alone therapy is done and what impact a "soft" balloon inflation after atherectomy may have with regard to patency rates.

more...Source

Landmark approval for Cardiovascular risk screening test

Efforts by the Society for Heart Attack Prevention and Eradication (SHAPE) have lead to the passage of landmark legislation that requires insurers to pay for either a noncontrast CT (calcium scoring) or ultrasound to evaluate carotid intima-media thickness ratio.

Hopefully, this state legislation will be adopted nationally to the end of diminishing the number of deaths due to cardiovascular disease-the number one killer of Americans through heart attack and stroke

Source

Pathway's Jetstream G2 up close and personal

I attended a single day conference focusing on atherectomy and the use of the Jetstream G2 atherectomy/thrombectomy device from Pathway Medical. I've posted quite a bit about the atherectomy space in vascular therapy. That's because, I think that it represents a critical phase of technology innovation in the treatment of infrainguinal PAD   Currently, all the available therapies are plagued by differing failure modes. Angioplasty, stenting and atherectomy have various mechanisms of failure at different intervals. And different therapies may selectively benefit various disease types. SFA disease represents a large challenge with various options for treatment. see sfa challenge   The Jetstream G2 represents the second generation of the Pathway device. It now has a thrombectomy indication which makes it quite appealing. In the demonstrations of the device, it performed remarkably well in the treatment of CTO's of the SFA. There is an emerging body of treatment philosophy that traversing CTOs intraluminally as opposed to subintimally will provide the best opportunity to utilize future technology such as drug eluting balloons and stents. With this in mind, the Jetstream was used in combination with the Crosser device (FlowCardia Inc., Sunnyvale, CA) which allows central crossing of the lesion.   In most cases, IVUS verified a concentric crossing of the total occlusion with a luminal size of 2.7-3.5 mm. The primary treatment with the Jetstream was complimented by low pressure balloon angioplasty.   The technology seemed to work very well in In Stent restenosis which has a very high recurrency rate with limited effective treatment modalities currently. Additionally, it proved highly effective at penetrating fibrocalcific plaque formation.   Treatement times were somewhat prolonged depending on the plaque mophology.   The advantages of the Jetstream over the diamondback from CSI appear to be the ability to treat longer lesions at one setting in less time with the same device. The Jetstream sizes from 2.1 up to provide flexibility and cost savings from using only a single catheter per treatment   Additional data will be forthcoming, however, I was pleasantly surprised at the results seen in the live demo cases

Medical Device and Healthcare Reform

Although Wallstreet has yet to show any evidence, concerns abound within the medical device industry regarding the impact of potential national healthcare reform. Atherectomy is a perfect example of a device category which may suffer from the financial squeeze that hospitals will experience with a move to subsidize only evidenced based technology

Healthcare IT and generic drugs will core big, but medical devices, big pharma, and health insurers will take a hit, according to Wachovia survey.

Comprehensive healthcare reform will give a big lift to healthcare information technology and generic drugs, but it will hurt the medical device industry, according to a survey by Wachovia Capital Markets LLC.

The report, "The Changing Face of Heathcare," was compiled from data of a survey of more than 200 institutional investors, more than half in the northeastern United States.

About 71 percent of respondents thought Congress would pass some sort of healthcare reform in 2009, but less than 25 percent thought a single-payer system, similar to Canada's or Great Britain's, was likely.

As for its impact on business, more than 76 percent of the investors said healthcare reform would have a modest to negative impact on the medical device industry. Orthopedics, cardiovascular and medical equipment budgets might face the biggest challenge, according to investors, while diagnostics would likely fare better.

And comparative effectiveness research will likely have a deflationary effect on pricing, they indicated. More than 80 percent said the new emphasis on evidence-based medicine would have a slight to substantially negative effect on medical technology pricing. Most of the respondents said pricing pressure from hospitals would be a graver threat to the sector's health.

The report contained a sliver of a silver lining: Respondents seemed to think the impact wouldn't be immediate, with the most dramatic effects occurring about five years out.

Meanwhile, they said, generic drug makers and HIT firms would benefit significantly from the efforts underway in Washington.

June 26, 2009 by MassDevice staff