Vascular Device Forum

Vena Caval Filter Update: Is anyone still using the Trapease/Optease?!?

Pulmonary Emboli (PE) are responsible for more deaths annually than breast cancer, AIDS and motor vehicle accidents combined. Prevention of Pulmonary embolism represents an important aspect of care for the vascular practioner. Numerous filters are available for implantation to prevent pulmonary embolus. Available filter types are listed below 

IVC filter brands

• B Braun Tempofilter IVC filter (retrievable)
• B Braun VenaTech LGM IVC filter (no longer sold)
• B Braun VenaTech LP IVC filter
• Bard G2 IVC (retrievable, unlimited indwell time)^[2]
• Bard Recovery IVC filter (retrievable) (no longer sold)
• Bard Simon Nitinol IVC filter^[3]
• Boston Greenfield IVC filter
• Cook Birds Nest IVC filter
• Cook Celect IVC filter (retrievable)
• Cook Gunther Tulip IVC filter (retrievable)
• Cook Gianturco-Roehm Bird's Nest IVC Filter (not retrievable)
• Cordis OptEase IVC filter (retrievable, 23 day indwell time)^[4]
• Cordis TrapEase IVC filter
• Mobin-Uddin Umbrella IVC filter (no longer sold)
• ALN IVC filter (retrievable)
• Rex Medical Option IVC filter (retrievable) (in clinical trials)

Recent data has emerged that the Optease/TrapEase device from Cordis are associated with a higher incidence of vena caval thrombois. Singer et al in JVIR 2009 Jun;20(6):799-805 and Leask RL et al JVIR 2004 May;15(5):485-90 used different models to assess the TrapEase's function. Singer et al using a three dimensional computer model of the TrapEase filter, examined the hemodynamics of steady state flow in the unoccluded and parially occluded filter. The study concluded that the upstream trapping position of the TrapEase filter leads to a potentially thrombogenic region of stagnant and or recirculating flow with low shear stress. Furthermore, the authors stated "these findings are supported by clinical studies showing an increased incidence of occlusive and nonocclusive thrombi"

Leask et al summarized that "there is a tendency for clots to be trapped between the filter and the vessel wall in the inferior inlet region. A clot in this region will generate a large region of flow stagnation/recirculation that is considered to be prothrombotic. In addition, a significant amount of the filter wire will be embedded in this region, which may promote thrombosis."

I would be interested to hear the feedback of practicing clinicians. I suspect that there is a specturm of opinions depending upon the type of practice ie vascular surgeon, IR and the setting ie community, academic. An extensive caval thrombus patient is likely to require lysis and if the filter placement individual is not the person that performs thrombolysis or if the patient is transferred to another facility do to extensive caval thrombus, then the person who placed the filter might not be aware of this type of potentially delayed complication.

Elsewhere,recently companies like Cook Medical have introduced technical iterations on currently existing devices like the Celect and Tulip vena caval devices. The NavAlign delivery system, available for both the Cook Celect® and Günther Tulip™ filters, is designed to minimize trauma and streamline filter placement with features unavailable on any other existing deployment system. A hemostatic valve minimizes blood loss at the point of entry, while a multipurpose dilator has radiopaque sizing bands and flushing sideports that decrease fluoroscopy time and the amount of contrast medium required.

I suggest that the the OptEase and TrapEase have had market share because of the first entry advantage and the associated clinical ease of deployment, however with advances in technology ongoing re-evaluation of practice patterns are necessary to provide the best outcomes to our patients

View deployment of the Guenther Tulip from Cook Medical

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Cook Medical's Zilver PTX stent performs well in Europe

In August, Cook Medical  announce CE Mark approval for the Zilver PTX Stent, the first-ever drug-eluting stent designed specifically to treat severe blockages in the superior femoral artery (SFA). As you may know, the paclitaxel-coated Zilver PTX is also the first DES that eliminates the use of a polymer to adhere the drug to the stent, significantly diminishing the occurrence of potentially dangerous reactions experienced in some patients.

Approval of the polymer-free Zilver^® PTX^® Drug-Eluting Peripheral Stent from Cook Medical, a world leader in minimally invasive diagnostic and interventional devices, represents a global landmark in effective peripheral intervention for treating PAD, a chronic disease affecting tens of millions of patients worldwide that is a leading cause of leg amputation and shortened lifespans.

Cook’s Zilver PTX is specifically designed and approved to treat PAD affecting the main blood vessel in the thigh, the superficial femoral artery (SFA). It is a self-expanding stent made of nitinol, a space-age ‘shape memory’ metal that offers unique mechanical advantages for a stent in the SFA.

By eliminating the need for a polymer or plasticizing agent to hold the drug to the stent body, Cook has created a medical breakthrough that solves two key problems. First, it allows targeted delivery of a drug (paclitaxel) proven to reduce the renarrowing (restenosis) of arteries opened using balloon angioplasty. Second, by eliminating the need for a polymer, which was left behind on the body of earlier drug-eluting stents after the drug dissolved into the surrounding tissues, Zilver PTX avoids the potential patient risks posed by leaving a permanent foreign, plastic substance in the body. In addition, the Zilver stent was proven during its clinical trial to be the most durable peripheral stent available, suggesting even greater patient safety, according to the clinical trial data.

The CE Mark follows the world’s largest-ever clinical trial for a peripheral stent, led by 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, Palo Alto, California. The data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and Korea and demonstrated highly positive results. Only 8 percent of all patients with de novo (new) lesions needed a reintervention to reopen the artery in the first 12 months – a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal (non-drug-eluting) stents.

Also, specific patient groups that are often very hard to treat, such as diabetics and patients with in-stent restenosis (those treated previously with a noncoated stent), were shown in the trial to benefit from the Zilver PTX. As the trial data indicate, the superior results achieved in the first year have been largely maintained throughout 24 months, an important clinical milestone. In comparisons with other trial data obtained, the Zilver PTX stent showed a reduction in reintervention of between 50 percent and 75 percent, an important patient benefit.

“The awarding of the CE Mark is set to herald a revolution in the treatment of peripheral arterial disease,” comments Dr. Michael Dake. “This global study proves that the Zilver PTX has the integrity, safety and durability needed to successfully address many of the well-known limitations of current treatments for the management of PAD.”

Rob Lyles, global leader and vice president of Cook Medical’s Peripheral Intervention division states, “We’ve specifically designed the Zilver PTX to be safer and more effective for PAD patients by engineering this device for the unique demands of treating this disease in the SFA. It’s polymer-free, it’s fracture resistant, and through the largest trial of its nature in history, it’s been clinically proven to be significantly more effective in treating peripheral arterial disease in the SFA than other treatment modalities.

“Our unique ability to adhere the drug to the stent without using a polymer is a major clinical advantage. It eliminates the risk some patients may face due to reactions and other potentially poor outcomes that are associated with polymer coatings used on current generations of drug-eluting stents. It’s a truly exciting time for Cook Medical and our partners, as well as for physicians and patients alike. With the European launch of this first-of-its-kind 21^st century medical technology, we are truly at the vanguard of a revolution in peripheral intervention.”

Following more than 1,200 patients treated worldwide during its clinical evaluation and CE Mark approval on July 24, 2009, the first commercial implantations of the Zilver PTX stent were conducted August 10 in a coordinated effort by physicians in the United Kingdom, Germany, France, Holland, Belgium, Sweden, Switzerland and Spain. In the United States, the Zilver PTX drug-eluting stent is an investigational device not available for sale.

This breakthrough technology represents a major innovation in the treatment of PAD which occurs in the challenging terrain of the SFA. The stress and strain forces of this dynamic vessel, especially at the adductor canal requires unique technology. Thus far, the data demonstrates fracture resistance and avoidance of the sequellae associated with drug eluting platforms.

Syvek patch from Marine Technologies

I had the opportunity to use the Syvek Patch from Marine technologies. The Syvek uses a proprietary technology to accentuate the body's own coagulation systm. Leaving nothing behind. The Syvek patch is the next technology in the new generation of devices that strive to avoid some of the foreign body associated complications associated with the earlier generation of vascular associated closure devices.

The technique was relatively simple requiring no significant learning curve. A patch is placed over the puncture site after the sheath is removed. secondary Pressure was held at the level of the arterial puncture site. A small amount of blood is allowed to exit the tract to activate the patch and then pressure is held for 10-15 minutes.  Ambulation is expidited and can usually occur at 2 hours post pull

Some preliminary results exist in the cardiology, trauma which appear to be promising. Who has experiences with this new device

Cook gains FDA approval for Pro-Form version of TX2 for TEVAR

Physicians performing thoracic endovascular repair (TEVAR) now can achieve even greater levels of control during endograft deployment compared to the original TX2 device with Cook Medical’s new Zenith® TX2™ TAA Endovascular Graft with Pro-Form™. Cook’s new TX2 Pro-Form endograft, which has now obtained FDA approval, utilizes an improved delivery system that allows for carefully controlled deployment of the endograft to help establish proximal conformity of the device to the aortic wall. This innovation in endovascular TAA repair was engineered especially for procedures in which endografts must be positioned in tight aortic arches that are notoriously difficult to seal properly.

I previously posted comments from a conversation with Bart Muhs MD regarding future iterations for the TEVAR space

Many earlier endografts were too rigid or possess sealing stents that lack the radial force to conform correctly to the inner curvature of tight aortic arches, preventing the graft from properly sealing off the aneurysm. Consequently, surgeons have historically been forced to remodel the arch with a balloon or use other aids to position the graft, in an effort to reduce the risk of continued bleeding into the aneurysm and possible rupture. As a result, these difficult repair procedures are often long and complex. The TX2 Pro-Form’s enhanced delivery system may mitigate the need for such additional measures.

www.zenithstentgraft.com

Later this week Ill post comments from my conversation with Mr Ray Leonard, Global product manager of thoracic endografts.

The anatomic challenges of the tight aortic arch are felt to affect 25% of candidates for thoracic repair of aneurysms. The presence of the challenging anatomy may lead the surgeon to perform open aneurysm repair with the associated increase in morbidity and mortality.  Or TEVAR may be performed if open surgery is not an option, resulting in a less durable and more uncertain long term result

Check back for part II on the topic of Zenith TX2 Pro-Form

Synthes Inc Executives plead guilty and face up to 1 year prison time

Although this topic is outside the field of vascular medical devices it does set a precedent for medical devices in general. The general background is that Synthes Inc is a maker of orthopedic related medical devices. The company is accused of facilitating the use of their product, Norian XR in an off label, non FDA approved, use which resulted in the death of three patients.

“Today’s resolution is grounded in the principle that Mike Huggins was a responsible corporate officer at Synthes,” Mr. Huggins’s lawyers, Gregory Poe and Catherine Recker, said in an e-mailed statement.

Source

The executives, Michael D. Huggins, 51, of West Chester, Pa., and John J. Walsh, 46, of Coatesville, Pa., pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines.

The NY Times first reported this story June 16, 2009

In the indictment, prosecutors charged that Synthes officials considered seeking permission in 2001 from the F.D.A. to run a trial of the bone filler in back operations but rejected the idea. Instead, company officials approached selected doctors to do operations with the understanding that the company “would help them publish the clinical results,” the indictment charges.

The filler was approved in 2002 by the F.D.A. for use in general bone repair, but regulators insisted that Synthes not promote its use for spinal procedures.

By 2002, Synthes had received information from a researcher at the University of Washingtonwho reported lab and animal tests showing that Norian bone filler could generate large blood clots if it escaped from bone, the indictment states.

Shortly afterward, executives considered alerting the sales force not to promote the bone filler for unapproved uses, but they decided not to do so, prosecutors charged. Instead, the device maker began to hold sessions for doctors on how to use the bone filler and was about to promote it more aggressively when the company received a report in 2004 about the death of a third patient, court papers state.

The company, which never reported the patient deaths to the F.D.A., also misled an agency inspector, prosecutors charged.

Norian faces possible fines of $28 million, while Synthes, its parent, faces fines of $8 million.

The individuals charged are Michael B. Huggins, the president of the Synthes spinal division; Thomas E. Higgins, the company’s senior vice president for global strategy; Richard E. Bohner, a vice president for operations; and John J. Walsh, a regulatory affairs executive.

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].

 

Pathway Medical Technologies Paul Buckman shares vision

I recently had the opportunity to speak to Pathway Medical's CEO Paul Buckman. In 2008, Pathway Medical Technologies received FDA approval for the Jetstream G2 for peripheral atherectomy. This was followed by approval for arterial thrombectomy in 2009. The Jetstream G2 enters an atherectomy field which features EV3's Silverhawk and CSI's Diamondback system.

Mr Buckman is a former protege of who some consider the father of atherectomy, John Simpson,former CEO of Foxhollow technologies. Mr Buckman recalled being hired by Simpson and learning some critical lessons of device development. Including the continual need to welcome feedback from the end user in an attempt of improve device function and patient outcomes. This important philosophy appears to be a cornerstone of the company culture at Pathway Technologies.

Mr Buckman brings a wealth of experience and corporate experience in the medical device space. From the Pathway Medical Technology website:

Paul brings more than three decades of medical industry leadership to Pathway Medical, where he recently served as chairman of the Board of Directors. He joined the company from Devax, Inc. where he served as chief executive officer and board member since December 2006. From August 2004 to December, 2006, Paul was president of the Cardiology Division of St. Jude Medical, Inc., a diversified medical products company. Prior to St. Jude Medical, he served as chairman of the Board of Directors and chief executive officer of ev3, LLC, a Minnesota-based medical device company focused on endovascular therapies that Paul founded and developed into an $80 million business. Paul’s 30 years in the medical device industry include 10 years at Scimed Life Systems, Inc. and Boston Scientific Corporation, where he held several executive positions before becoming president of the Cardiology Division in January 2000. Paul currently serves as a board member for SentreHeart, Inc and has held posts on the boards of Velocimed, Inc., where he was a co-founder, EndiCor, Inc., Microvena, Inc. and Micro Therapeutics, Inc. Source

On the financial side, Mr Buckman states that Pathway recently obtained a fresh round of cash infusion which allows them to focus on the busines at hand and sell some of the recently released devices. His company vision appears to be to create a strong peripheral vascular device with a broad range of device offerings. With regards to the landscape of the atherectomy space, Mr Buckman offers a view that there remain a large number of physicians who are not comfortable with atherectomy and the room for growth outside of the currently offered atherectomy devices is substantial. And the number of patients with infrainguinal disease treated with atherectomy is relatively small.

From the short conversation, it appears that Pathway is headed for years of success.

I encourage physicians using the pathway device to offer feedback on device function, current applications and future iterations

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

Finally: Some data on Atherectomy Silverhawk EV3

EV3 announced plans to assess atherectomy as a stand alone intervention using their device, the silverhawk device. Its been a long time coming to get some data on short and midterm results of percutaneous atherectomy using a core lab. It will be interesting to see the details of the study design and lesion inclusion. This comes on the heels of the launch of LifePath's G2 Jetstream device.

On thing is for sure, if the results are good, every atherectomy company will piggy back and if the results are bad-"Our device is better than EV3's"

 

EV3 Commences DEFINITIVE LE Postmarket Study of SilverHawk

April 30, 2009—ev3 Inc. (Plymouth, MN) announced that the first patients were enrolled in the company's DEFINITIVE LE postmarket study of stand-alone SilverHawk plaque excision therapy for the endovascular treatment of lower extremity peripheral arterial disease (PAD). DEFINITIVE LE is a prospective, multicenter, single-arm study that will evaluate the intermediate and long-term effectiveness of the therapy. The study is expected to enroll up to 800 patients from 50 clinical sites in the United States and Europe. It will evaluate 1-year patency in patients with claudication and 1-year limb salvage in patients with critical limb ischemia. A third-party review of the results by independent core labs will also be included in the study. James McKinsey, MD, and Lawrence Garcia, MD, are coprincipal investigators for DEFINITIVE LE.

According to ev3, the DEFINITIVE LE study represents the second study in the company's DEFINITIVE clinical study program to confirm the value of plaque excision with the SilverHawk system. A United States investigational device exemption study, called DEFINITIVE Ca++, is currently being conducted to evaluate the use of the SilverHawk-R LSC (RockHawk) plaque excision system and the SpiderFX embolic protection device in the endovascular treatment of moderate-to-heavily calcified peripheral artery lesions.

"DEFINITIVE LE will provide much needed guidance on the treatment of PAD using plaque excision in both above- and below-the-knee applications," commented Dr. Garcia. "Furthermore, this study will potentially add new insight on the optimal management of diabetic patients in this very difficult vascular territory."

Definitive Study

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.