BB&T, and Staff Reports

Eighteen patients in Europe on July 10 received the first CE mark approved drug-eluting stent (DES) designed specifically to treat severe blockages in the challenging and largest artery in the leg, according to Cook Medical (Bloomington, Indiana). The device – the polymer-free Zilver PTX drug-eluting peripheral stent – opens up a treatment option to patients in Europe that didn't exist before that day.

"That's 18 people that [the prior] week didn't have access to it," Rob Lyles, global leader and VP of Cook's Peripheral Intervention division, told Biomedical Business & Technology. "That's a good day."

According to Cook, the CE mark of the Zilver PTX represents a "global landmark in effective peripheral intervention for treating peripheral artery disease (PAD), a chronic disease affecting tens of millions of patients worldwide that is a leading cause of leg amputation and shortened lifespans."

Prior to Cook's Zilver PTX receiving CE mark, PAD patients in Europe had three treatment options, Lyles said: surgery, balloon angioplasty, or a bare metal stent.

The first option, surgery, is accompanied by the pain of undergoing surgery, a hospital stay of at least a few days followed by recovery time, risk of infection, and probably two to three weeks off of work, Lyles said.

Second, he said, if a patient with PAD in Europe finds a doctor who will do a minimally invasive procedure, 40% of the time that physician is going to do a balloon angioplasty. That statistic "blows me away," Lyles told BB&T, because that procedure fails 70% of the time and the patient has to go back for a repeat procedure, usually two years later. "That means that 40% of the time they are going to get a technology that we know is going to fail them."

The third treatment option available prior to this CE mark, treatment with a bare metal stent, is better than the first two options, however the success rate is still only 75% to 80%, compared to the Zilver PTX data which is showing success 92% of the time.

Cook licenses the rights to use paclitaxel on peripheral stents and other non-coronary medical devices from Angiotech Pharmaceuticals (Vancouver, British Columbia).

From a corporate standpoint, Lyles said Cook is "very enthused" about the CE mark, and that it thinks the Zilver PTX stent has the potential to "really drive a tremendous amount of market share."

"There is just nothing else out there from our competitors that's even close," Lyles said.

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 says it 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.

According to Cook, the CE mark follows the world's largest-ever clinical trial for a peripheral stent, led by Michael Dake, MD, 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," Cook noted. Only 8% 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 stents, the company said.

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 non-coated 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, Cook said. In comparisons with other trial data obtained, the Zilver PTX stent showed a reduction in reintervention of between 50% and 75%, an important patient benefit.

Following more than 1,200 patients treated worldwide during its clinical evaluation and CE mark approval on July 24 the first commercial implantations of the Zilver PTX stent were conducted Monday in a coordinated effort by physicians in the UK, Germany, France, the Netherlands, Belgium, Sweden, Switzerland and Spain. In the U.S., the Zilver PTX DES is an investigational device not available for sale. Lyles told BB&T that Cook is looking to bring the device to the U.S. market in the next 18 months, but of course that is purely speculation, he said.

PLC in distribution accord for RenalGuard

PLC Systems (Franklin, Massachusetts), a company focused on cardiac and vascular device-based technologies, reported that it has entered into a three year exclusive agreement with Medimen, headquartered in Pakistan, for distribution of its RenalGuard System into Bangladesh and Pakistan.

Medimen is an established distributor of medical technology and devices in this region, and has previously worked with PLC on distribution of the Heart Laser System. Medimen has already launched RenalGuard in Bangladesh, and will target early adopters in both countries who recognize the benefits of utilizing the unique fluid balancing capabilities of RenalGuard in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of Contrast-Induced Nephropathy (CIN).

Bangladesh and Pakistan join Italy and Spain as countries where PLC has now launched RenalGuard. PLC received the CE mark certificate for the RenalGuard System in late December 2007, and concluded its pilot safety trial in the U.S. late in 2007. Two investigator-sponsored randomized clinical trials to evaluate the use of RenalGuard in the prevention of CIN are currently underway in Italy. Recently, PLC was awarded its first patent for RenalGuard technology, in Canada.

PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.

Rosetta enters distribution deal with Warnex

Rosetta Genomics (Philadelphia/Rehovot, Israel), a developer of microRNA-based molecular diagnostics, and Warnex Medical Laboratories (Laval, Quebec), a division of Warnex (Laval), have signed an exclusive distribution agreement in Canada for three currently-available diagnostic tests.

Warnex will market Rosetta Genomics' miRview tests. Samples will be sent from Canada to Rosetta Genomics' Philadelphia-based CLIA-certified laboratory for analysis. Financial terms of the deal were not disclosed.

"We are excited to have a well established molecular diagnostic laboratory such as Warnex as our distribution partner in Canada," said Ronen Tamir, chief commercialization officer at Rosetta. "Canada is an important market, and this agreement is a significant step as we expand the market for our products in North America. This agreement joins our existing contracts with Prometheus Laboratories in the U.S., and with Teva Pharmaceuticals in Israel and Turkey. We continue in our efforts to expand our global distribution network to other parts of the world, and expect to have additional agreements in place in the near future."

UK hospitals order Varian machines

Developers behind an ambitious project to redevelop one of London's leading cancer centers have ordered four new radiotherapy treatment machines from Varian Medical Systems (Palo Alto, California). Barts and The London NHS Trust is acquiring the new Clinac linear accelerators as part of a high-profile 1 billion private finance initiative scheme and treatments are due to commence at Barts and the London Cancer Centre at Barts Hospital next spring. The new machines are equipped with On-Board Imager devices and RapidArc capability and will enable Barts to expand its intensity modulated radiotherapy (IMRT) program and offer advanced treatments to more patients. RapidArc delivers a precise and efficient radiotherapy treatment in single or multiple rotations of the treatment machine around the patient and makes it possible to deliver image-guided IMRT two to eight times faster than is possible with conventional IMRT.

Adaltis files for bankruptcy in Canada

Medical device maker Adaltis (Montreal) said it voluntarily filed for bankruptcy in Canada to effect an orderly liquidation of its assets, property and operations.

Cash-strapped Adaltis, whose shares were delisted as part of a reorganization, said operations outside of Canada are not included in this voluntary assignment in bankruptcy.

The filing terminates the protection of the court granted under the companies' creditors arrangement act (CCAA) on July 3, the company said in a statement.

Adaltis, which specializes in in vitro diagnostic products, said the implications for creditors and other stakeholders will not be known until the liquidation process is complete.

Adaltis said directors of the company have resigned and RSM Richter has been appointed as trustee in bankruptcy.

The company has offices in China, Italy, Mexico and other parts of the world, it said.

Adaltis offers diagnostic products, including automated diagnostic systems consisting of instruments, reagents and software, which test for a range of medical conditions. Its software assists in the interpretation of data collected from its instruments and reagents. Adaltis also provides services to its customers, such as installation, technical training and support. Its customers consist primarily of small and medium-sized laboratories and hospitals. Its sales force concentrates on the Chinese and Italian markets, while its third-party distribution network reaches customers in other countries worldwide.

Invo inks contracts in Latin, South America

Invo Bioscience (Beverly, Massachusetts), a medical device company focused on treatment options for patients diagnosed with infertility, reported the signing of three distribution contracts in South and Latin America.

The Daxley Group will distribute for Invo in Columbia, Venezuela, Ecuador, Panama, Mexico, Brazil, Chili, Argentina and Uruguay.

Nacer, Center for Human Reproduction (Lima, Peru) has started treating patients with the INVO procedure under Julio Diaz, MD, and has been contracted to distribute the Invocell to IVF centers and OB/GYN's in Peru.

CER, Center for Human Reproduction, under the direction of Vivian Lopez Leon, has started treating patients with Invo and has contracted to distribute the product in Guatemala, Belize, El Salvador and Honduras.

"These agreements will allow Invo to begin the process of treating over 9 million estimated infertile couples in South and Latin America. Invo Bioscience's goal is to develop this untapped market and treat 5% of this population over the next 5 years," said CEO Kathleen Karloff.

The company's patented product, the Invocell, allows for vaginal incubation of eggs, sperm and early embryo development during the infertility treatment process.

The Invocell has already received CE mark approval and the company began selling units in late 2008 in select countries outside the U.S. The company said it is pursuing FDA clearance for the system.

NeuroLogica CT scanner approved in Brazil

NeuroLogica (Danvers, Massachusetts), a maker of portable medical imaging equipment, said that ANVISA: National Health Surveillance Agency (charged with ensuring the safety of medical devices in Brazil) has granted marketing approval for its portable CT scanner, CereTom.

The CereTom is a portable eight-slice CT scanner that can be used in the ICU, ER, OR, NICU, MICU, SICU, interventional suite, or any medical clinic. The CereTom is compact and lightweight; only 29 inches (74 cm) deep, five feet (153 cm) tall and four feet (134 cm) wide and weighs approximately 750 pounds (341kg).

"We are extremely pleased with this new approval in Brazil. The CereTom will now be poised and ready to help save lives in this corner of the world." said Eric Bailey, president/CEO of NeuroLogica. "We believe the performance and convenience of our portable CT scanner will make a positive contribution to the quality of healthcare throughout the largest country in South America, Brazil."

CMS Medical, based in Brazil, is the local representative/distributor for the CereTom.

AMD completes e7.5 million 'C' round

Advanced Medical Diagnostics Holding (AMD; Waterloo, Belgium), a privately held company committed to providing computer-aided solutions (HistoScanning) that improve the diagnostic interpretation of ultrasound scans, reported the completion of a Series C round investment securing a total financing package of e7.5 million.

HistoScanning is a tissue characterization technology that has been developed to differentiate, characterize and visualize solid organ tissue types based on the analysis of backscattered ultrasound. It is designed to support the physicians' diagnosis and treatment decisions.

Prostate HistoScanning, released in Europe, is a specific product to support the management of men suspected of or presenting with prostate cancer. HistoScanning products for breast, thyroid and ovaries are under development.

UK to ban private organ transplants

The British government said that it plans to ban private organ transplants from dead donors to allay fears that prospective recipients can buy their way to the front of the line. A government-commissioned report recommended that organs donated within the state-run National Health Service should stay within the public health system.

Very few Britons have private transplants, so in practice the new rules will stop overseas patients from coming to Britain and paying privately for a transplant.

The report by Elisabeth Buggins, former head of the Organ Donation Taskforce, was commissioned after a media storm over cases in which foreign patients were given transplants from dead Britons.

Buggins said that for most people, "financial gain from the transplant of donated organs feels morally wrong."

She said most people who wanted to donate their organs assumed they would be given to people on an NHS waiting list, and the idea of "queue-jumpers" could deter donors.