Vascular Device Forum

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

Pathway Medical has new 7 fr Jetstream G2 for Atherectomy, Thrombectomy

Pathway Medical announced further iterations of the G2 device for Atherectomy and thrombus removal

 

PATHWAY MEDICAL TECHNOLOGIES INTRODUCES JETSTREAM G2™ NXT

 

 Smaller 7 French Compatible Atherectomy Catheter Now Available to Treat Larger Patient Population

 

KIRKLAND, WA––August 10, 2009––Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral arterial disease (PAD), today introduced the 7 French compatible version of its peripheral atherectomy catheter. Jetstream G2™ NXT is based on the company’s state-of-the-art catheter technology capable of treating the entire spectrum of disease found in patients suffering from PAD, including hard and soft plaque, calcium, fibrotic lesions and thrombus. 7 French compatibility allows physicians to use Jetstream G2 NXT in the treatment of PAD in a more diverse patient population, significantly expanding the number of patients who can now benefit from this innovative technology. 

 

“The 7 French compatible Jetstream G2 NXT is nearly identical to Jetstream G2, but has the advantages associated with smaller sheath technology,” said Dr. Robert Bersin at Seattle Cardiology. “As such, it expands my ability to treat more anatomies and patients with varying degrees of PAD.”

 

Approximately 12 million Americans suffer from the effects of PAD and many in this rapidly expanding patient population go undiagnosed. Commonly associated with high blood pressure, diabetes, heart disease, stroke and aging, PAD causes a build-up of plaque within the arteries that limits blood flow to the extremities. PAD can lead to severe limb pain, non-healing ulcers and critical limb ischemia and, if left untreated, can lead to gangrene, amputation and even death. The most common intervention for PAD has historically included highly-invasive procedures, including bypass surgery. Unfortunately, many patients are poor surgical candidates for whom surgery can be life threatening. Atherectomy—the removal of the blockage by inserting a specialized catheter into the artery to remove the fatty buildup from the artery walls—has proven to be an effective, first-line option in minimally invasive PAD intervention. Yet, until now, atherectomy devices have not been effective in removing all types of hard and soft tissue plaque.

 

“Today’s news coupled with the recent FDA clearance to market Jetstream G2 for thrombus removal

underscores our unwavering commitment to provide new and better treatment options for the millions of Americans suffering from PAD,” commented Pathway Medical Technologies President and CEO Paul Buckman. “With the introduction of Jetstream G2 NXT, we are able to provide much needed atherectomy treatment to an expanded patient population.”

 

 

 

 

About Jetstream G2 NXT

Jetstream G2 NXT is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD.

 

Jetstream G2 NXT consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. A highly efficient aspiration port located just proximal to the cutting blades continually removes excised tissue and thrombus from the treatment site to a collection bag located on the console. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. Active aspiration is a safety feature that minimizes the risk of distal embolization.

 

With simple set up and an ergonomic design for easy operation by trained clinicians, Jetstream G2 NXT maximizes treatment effectiveness and offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

 

About Pathway Medical Technologies, Inc.
Pathway Medical Technologies, Inc. was founded to design market and manufacture medical devices for the treatment of vascular disease. The company’s initial focus is treating peripheral arterial disease (PAD) more quickly and effectively than existing technologies. An estimated 12 million people are afflicted by PAD in the

U.S.

and that number is projected to grow to over 20 million during the next 10 years. The company’s Jetstream® device allows for a minimally invasive procedure designed to restore circulation in the peripheral arteries by removing both hard and soft diseased tissue. For further information, visit the company’s Web site at www.pathwaymedical.com.

FDA grants approval to Cook for Pro-Form version of TX2

On Monday July 27, 2009, Cook medical announced that they received FDA approval of the Pro-Form version of the TX2 thoracic endograft. The TX2 device was approved spring of 2008. Since that approval Cook has been aggressive in modifying the device three times to meet the anatomic challenges of difficult aortic arch anatomy. These changes are essential to assisting the clinician to broaden the population of patients that can be treated with minimally invasive technology and to produce durable results following repair.

For those of you who are interested in reading unique insights into EVAR technology and strategies, Cook sends out a monthly newsletter with aricles from respected clinicians and researchers about topics such as managing difficult access issues.Click here to read The Landing Zone

Device Description

The Zenith TX2 TAA Endovascular stent graft is designed as a two-piece modular system, although implantation of a single device may be sufficient for focal thoracic aortic lesions (see fig 8). The Zenith TX2 endograft is constructed of Dacron fabric covered by stainless steel Z-stents. In this device, the proximal end is covered and has stainless steel barbs protruding through the graft fabric (fig 10), which anchor the graft directly to the aortic wall. This also protects against distal stent graft migration during high-velocity systolic blood flow. The device uses an active fixation mechanism with external barbs oriented in opposing directions and designed to engage the aortic wall to decrease the risk of proximal and distal migration. Full deployment of the proximal stent is released by pulling a trigger wire once the optimal graft position is confirmed. The stents are modified Gianturco Z-stents, with small gaps left between each stent to allow some flexibility. Each end of the graft is held within a cap; inadvertent release during positioning within the aorta is prevented by a safety catch. The full length of the graft material is stent supported to prevent graft torsion or compression. The placement of the stents relative to the fabric is varied along the length of the device. At the ends of the endograft, the stents are sewn inside the fabric, whereas in its midportion, they are outside the fabric. The intent of this design was to optimize fabric apposition to the aortic lumen and fabric-fabric interstent junctions. The Zenith TX2 Proximal Component is available in diameters ranging from 28 to 42 mm and lengths from 12.0 to 21.6 cm. The Z-Trak delivery systems for the Zenith TX2 device have profiles between 20F and 22F. Device deployment is achieved by withdrawing an external sheath.source

The three iterations of the delivery system to date have included the 1) Flexor sheath 2)Z Trac Plus with a nitinol cannula for better trackability and the new 3) Pro-Form

Mr Leonard described the Pro-Form as a modification to the lead stent. The internal tracking wires teather the distal end of the first stent into the graft to pull the distal end inward so that the inferior aspect of the graft "hugs" the inferior wall of the aortic arch. The inferior wall of the aortic arch is the achilles heal of the tight aorta and in may leave the graft prone to mal apposition and subsequent migration or endoleak development

Bench testing with aortic flow models and curved radii models were favorable and the short term European results under very challenging anatomic conditions were favorable enough to get FDA approval on this device modification

The clincal launch is scheduled for November to coincide with the Veith meeting. The graft will be available at selected centers prior to that time. The plan is to roll out the new modification and exchange for the "old" version which will have the exchange completed by January of 2010

Perhaps the most promising use of this technology remains to be seen in the form of treatment for aortic dissection and thoracic aortic transections and traumatic disruptions. Cooks states that a phase I trial for this pathology is taking place at University of Florida, Mass General and Thomas Jefferson with the recent addition of Cooper Medical Center and The Cleveland Clinic

Special thanks to Mr Leonard for his time explaining this new and exciting technology

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

Medtronics CEO $8.9 million salary for 2009

TARP Money, Healthcare reform and economic recovery lead the morning news. Now the salary Czar is tackling Citi's $100 compensation package for  the energy division's star trader. Meanwhile at the healthcare reform table are physicians, insurers, pharmaceuticals, hospitals and corporations. What does this have to do with vascular devices? A recent AP wire story ran on the compensation for Medtronics CEO.

Medtronic’s CEO Bill Hawkins received $8.9 million in compensation in fiscal 2009. Hawkins took over as CEO last August and since then Medtronic has cut jobs and taken other steps to trim costs. A filing with the Securities and Exchange Commission showed his compensation included a $2.2 million performance bonus and $1.2 million in salary, plus stock worth $5.5 million

Not a bad year during an economic downturn. Medtronics opens the week at 35.4, down approx 30% YTD

Source

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