InSitu Technologies Inc

Technology Update - Aortic Valve Replacements

2012-02-01T14:19:00.003-06:00

We love hearing important industry news that relates to our products and gives so many families and patients hope. Check out this article about the state-of-the art technology of transcatheter aortic valve replacements. These valves are implanted minimally invasively through accessing the Femoral artery with a large sheath introducer. Physicians are requesting our Direct-Stent Stent Graft OTW be used as a complimentary device in this procedure as a fast, safe and effective solution to seal the large puncture site. This treatment gives many doctors and patients hope in situations where in the past the diagnosis was grim and many times inoperable. Speak with an InSitu team member to place an order for the Direct-Stent Stent Graft OTW today!

Cardiac Treatment Gives Hope to Inoperable Patients

Author: By Henry L. Davis, The Buffalo News, N.Y.

Jan. 24--Many patients with seriously narrowed aortic valves have faced a bleak future with no medical options, but a new procedure now offers the sickest of the sick a promising treatment.

Two patients are doing well after receiving a transcatheter aortic valve replacement, or TAVR, using the first artificial heart valve that can be implanted without major surgery, a team of Buffalo physicians says.

The physicians here are among the first nationally to use the Sapien valve, outside of doctors involved in the device's clinical studies.

"This is the most exciting thing in cardiology since stents were developed for heart disease. Patients who were written off for dead beforehand will now have a therapy," said Dr. Vijay Iyer, who led the surgical team. Edwards Lifesciences received approval for the device in November from the Food and Drug Administration.

Lifesciences estimates that 250,000 Americans suffer from severe symptoms of aortic stenosis, a narrowing of the main artery carrying blood out of the heart that occurs in older age. The company estimates a majority of the patients go untreated because the standard therapy -- open-heart surgery -- is too risky.

The heart becomes weak as it works harder to pump enough blood through a smaller opening, leading to such problems as heart failure. Once symptoms of severe aortic valve disease start, more than half of the patients die within two years, according to the FDA.

The new, minimally invasive procedure will be limited for the time being to certain patients and, likely, to medical centers with sufficient staff and facilities for the complex procedure. Only about 70 patients a year in Western New York are expected to meet the criteria, said Iyer, medical director of cardiology at Kaleida Health and an assistant professor of cardiology at the University at Buffalo.

"In health care, your volume of patients is a key determinant of quality. This is a technology that needs to be disseminated carefully," he said.

The valve replacement requires a team of specialists, including heart and vascular surgeons, specialists in heart imaging and cardiologists who perform angioplasty and other minimally invasive procedures.

The new valve, which consists of cow tissue and polyester attached to a stainless steel mesh frame, in most cases is inserted through the groin and advanced to the heart through blood vessels using a tiny tube called a catheter.

Using real-time X-rays for guidance, physicians blow up a balloon on the end of the catheter to expand the valve so it stays in place in the damaged or diseased aorta.

The procedure will open up a course of treatment to elderly or frail patients who are not good candidates for open-heart surgery and who have age-related aortic disease caused by calcium deposits. It is not approved for patients who can handle surgery.

The FDA's approval of the Sapien valve was based on a study of 365 patients who could not tolerate open-heart surgery. Half the patients received the Sapien valve, and the other half received another treatment that did not require major surgery.

Patients who received the new valve experienced 2 1/2 times as many strokes and eight times as many vascular and bleeding complications, the FDA reported, but the implant patients were more likely to be alive one year after surgery. Nearly 70 percent of the Sapien patients survived after one year, compared with 50 percent of those who received an alternative treatment, according to the FDA.

Newer research results indicate valve replacement patients may experience improved quality of life, including fewer repeat hospitalizations, compared with patients who receive a different treatment.

"This opens up a treatment door to patients who are older and sick with other problems, patients who basically faced a death sentence," said Dr. Anne Curtis, chairwoman of the UB Department of Medicine and a cardiologist.

Physician groups are working with government agencies to track patients who receive the valve replacement and to determine coverage under Medicare, the federal health plan for the elderly. Meanwhile, the procedure is being reimbursed on a case-by-case basis.

Doctors will have to carefully screen patients for the valve replacement, taking into consideration the patient's age, heart condition, level of aortic stenosis and other medical problems, Curtis and Iyer cautioned.

"We don't know the long-term benefits of TAVR," Curtis said. "We don't know how long they last. We have to be careful about jumping on a bandwagon too quickly."

Some physicians have questioned the results of the clinical trial of the Sapien device, asking if the better survival rate came about because the patients who received the alternative treatment fared worse than predicted.

The FDA must closely monitor the safety of the procedure, Drs. Rita Redberg and Sankret Dhruva of the University of California, San Francisco, wrote in the September issue of the New England Journal of Medicine.

One other area of concern revolves around likely pressure to expand the minimally invasive valve replacement beyond the sickest patients, as has happened in Europe, where the Sapien valve has been in use since 2007 and a second-generation device is under study.

Doctors say use of the valve replacement on younger or less-risky patients in the United State is unlikely anytime soon because of the need for more research. So far, doctors say the complications are acceptable only for inoperable patients who have no other options.

Visit The Buffalo News (Buffalo, N.Y.) at www.buffalonews.com

Our team travels to Honduras.

2012-01-23T10:48:00.002-06:00

This past December a few members of the InSitu team were asked to take a trip down to San Pedro Sula, Honduras. We donated many stents to the cath lab at Hospital Cemesa to help save the lives of patients with severe calcific lesions. Each of the patients treated was severely ill due to CTO lesion and multiple stenosis in the coronary arteries.

We were thrilled to watch Dr.Somoza perform procedures on patients using many InSitu products including the Direct-Stent Cobalt Chromium and Arriva PTCA catheters. The acute results were very satisfactory and all the patients were released within 24 hours.

This trip was invaluable to our team as we received first hand knowledge from the cath room floor. A big thank to Dr. Somoza and his team for making this possible and providing such a wonderful educational experience for our team.

The InSitu Team

SIR 2012

2012-01-17T13:08:00.000-06:00

The Society of Interventional Radiology (SIR) presents is 37th annual scientific meeting this March at the Moscone Center in beautiful San Francisco, California. We look forward to heading back to San Francisco and meeting new industry professionals to add to our growing network.

This will be our first time exhibiting at the SIR congress (Booth 338). The societies 4,300 members rely on the Society of Interventional Radiology (SIR) for education, advocacy, practice development, research forums and professional networking.

Please check out the SIR website for more information on registration and housing or send us an email. We would enjoy the chance to meet with you and your team, provide company updates and even insight into some of the latest radiology discoveries. We will be featuring some of our latest products including our InSituSeal™ Hemostatic Patch System, True PTA™ Balloon and Direct-Stent® Stent Graft over-the-wire (OTW).

See you in sunny SFO!

The InSitu Team

Stent Grafts in the Management of Traumatic Tibial Artery Pseudoaneurysms

2010-10-12T23:57:00.001-05:00

Traumatic tibial Artery Pseudoaneurysms have historically been treated through highly invasive surgical options. With the advent of newer minimally invasive technologies the challenges of invasive surgery in the peripheral anatomies can be mitigated. Reports on the use of these minimally invasive technologies for the treatment of Traumatic Tibial Artery Pseudoaneurysms can be found in many academic and non academic sources.
One of these reports is the case submitted by Dr. LARINI at the Italian Hospital “OSPEDALE MAGGIORE DI PARMA”, in which a 3.0 x 19 Direct-Stent Stent Graft was used in a 30 year old patient to successfully exclude a pesudoaneurysm obtaining great flow and patency. The patient was admitted with an aneurysm caused by an external tool in a work accident.
It's these amazing cases that excite us. We are pleased to share them with you and hope you will share with others.

Success @ TCT 2010

2010-10-05T14:18:00.001-05:00

Thanks to everyone who joined us at this year's annual TCT congress. We are happy to report a successful turnout of doctors, distributors and other industry professionals. This year we highlighted our Direct-Stent Stent Graft with bold ads in the TCT Daily and graphics in our booth. This generated alot of inquires and interest in the InSitu Stent Graft as well as many of our other products. We look forward to our next visit with many of you at EUROPCR 2011 in 17th - 20th of May.

InSitu on Facebook

2010-08-24T17:03:00.000-05:00

We recently launched our InSitu Facebook page. Stay connected and updated with InSitu while you Facebook. To become a fan click here!

InSitu @ SBHCI & SOLACI

2010-08-19T23:14:00.000-05:00

As the summer ends so does our trade show season. We recently returned from congresses in Brasil and Argentina. Both shows were successes both on and off the exhibit floor. We introduced some of our new products and met new members of the InSitu family from all over the world.

Our Forte Balloon

2010-07-30T01:08:00.000-05:00

We ran across a case study from Endovascular Today reported a 63 year old woman who was treated with a long balloon catheter to accompany cryoplasty for the treatment of a heavily calcified occlusion in the right superficial femoral artery (SFA).

An extra support .018” guidewire was used to reach the lesion and penetrate, with difficulty, halfway through the occlusion. At this time a 4.0mm x 100mm balloon catheter was inserted and tracked to the end of the guidewire. The guidewire and balloon were then advanced through the remainder of the occlusion. The balloon catheter was dilated several times for initial dilation of the 25cm length diseased segment. After dilating the vessel cryoplasty was used to treat the artery.

Follow-up angiography showed positive results with only mild residual stenosis at the previously occluded site. 8 weeks after the procedure the patient had no limitations due to due to claudication.

Typically heavily calcified lesions require a .035” guidewire and support from the guide catheter to cross the lesion. In this case the crossing was successful using only a .018” guidewire and a low profile, tapered tip PTA balloon. In this case ability to proceed with a 0.018” guidewire and PTA balloon catheter was an advantage.

Our Forte Long Balloon catheter is the perfect product for crossing and initial dilation of CTO long lesion occlusions in the superficial femoral artery. The Forte Long Balloon catheter tracks along a .018” guidewire, has a tapered distal tip, and is available in a variety of diameters (4-12mm) and balloon lengths of 100-200mm. Keep this in mind the next time your tackling a difficult lesion and ask your cath lab about Forte Peripheral Long Balloon.

Upcoming InSitu Events

2010-06-30T14:18:00.000-05:00

Summer is a busy time of year for us at InSitu. We just finished exhibiting at Europcr in Paris, France, this past May and are preparing for our next three shows. Europcr was a success. We met many new contacts as well as saw many familiar faces.
We begin on July 22nd with the SBHCI congress in Belo Horizonte, Brazil, one of the most important cities of Brazil and known internationally for the Pampulha suburb, which inspired Brasilia. InSitu is proud to exhibit for the first time in this city.
Next we move on to the Solaci Organization's annual congress this August 11th. This year the SOLACI organization and CACI organization of Argentina are joining forces to bring you a unique congress from the heart of Argentina, in beautiful Buenos Aires.
Lastly we end our summer and begin fall with a show in our home country, the United States, heading back to Washington DC on September 25th where will be exhibiting for the seventh time! Our U.S. show gives us a chance to show our appreciation for our loyal customers at our annual TCT distributor event.

Please join us for one of these fabulous shows where the latest advances in current therapies and clinical research will be showcased. We look forward to the next few months and hope we will see you at once of these stops.

Until next time,
hasta la próxima vez,
Até a próxima vez,

The InSitu Team

InSitu Blog Begins

2010-06-23T01:44:00.000-05:00

InSitu Technologies Inc would like to introduce you to our latest tool for keeping in touch with our vast network of distributors and physicians around the world, the InSitu Blog. The blog will update you on our products and events, as well as showcase the latest advances in current therapies and clinical research. So check back frequently for updates or click the Follow button on the right hand side of the page to follow us.