A Medical Device Daily

Medtronic (Minneapolis) said it has received regulatory approval from the government of China to begin selling its Endeavor drug-eluting coronary stent (DES) system in that country.

Made of a cobalt alloy and built on the same platform as the popular Medtronic Driver bare-metal stent, the Endeavor DES has a modular architecture designed to enhance deliverability. In addition to the drug compound zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, which aids in the healing response.

The company said China is one of the fastest-growing vascular markets in the world and one of the largest DES markets in Asia at more than $100 million. About 70,000 drug-eluting stents are implanted each year in China.

Dr. Ge Junbo, of Zhong Shan Hospital and co-chairman of the Shanghai Institute of Cardiovascular Diseases, said, “Evidence from the ENDEAVOR clinical trials and from commercial use around the world has confirmed excellent outcomes for patients. The number of times patients are required to return for repeat procedures is low and there also is a low rate of clinically adverse complications.”

In May, Medtronic presented data at the EuroPCR (Paris Course on Revascularization) conference that provided clinical evidence demonstrating the long-term safety and efficacy of the Endeavor stent. In addition to low rates of repeat procedures, the three-year and two-year results from the ENDEAVOR I and ENDEAVOR II clinical trials demonstrated low rates of major adverse events such as death and myocardial infarction.

There also was no late stent thrombosis reported in either of the two trials. For Endeavor patients who participated in the trials for at least one year, there have been no reported cases of late stent thrombosis, the formation of dangerous blood clots that potentially can lead to heart attacks or death.

“The Endeavor stent is proven to be safe and effective, and it is among the most deliverable DES products on the market,” said Max Muhs, vice president of Medtronic's vascular business in China. “We believe it offers the best combination of features among the drug-eluting stents available in Asia.”

He added that the approval for commercialization of the stent “further strengthens our commitment in China, following the recent opening of our physician training center in Beijing.”

With regulatory approval now granted in China and the recent announcement of reimbursement in France, the Endeavor DES is commercially available in some 100 countries worldwide. The stent received CE-mark approval in Europe in July 2005.

Medtronic anticipates approval in the U.S. in 2007.

SBI plans Mexican trial of Oxycyte

Synthetic Blood International (SBI; Costa Mesa, California) reported executing a letter of intent with an official from the Mexican government Institute of Social Security (IMMS) confirming its agreement in principle to conduct a clinical study in cardiopulmonary bypass surgical procedures with Oxycyte to support market approval in Mexico.

Oxycyte is SBI's perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.

The agreement calls for SBI to work with the IMMS, through a Mexican partner, in conducting a 50-patient cardiopulmonary bypass surgery registration trial, including providing Oxycyte and overseeing a U.S. clinical research organization that will monitor the study.

The IMMS will oversee the clinical study and prepare the required documentation for the application submission to the Mexican Ministry of Health. The IMMS also has indicated interest in exploring Oxycyte applications in additional medical procedures, including trauma and ischemia.

SBI is responsible for obtaining funding for the trial, but said no sources of funding have yet been identified.

The Mexican government requires that non-Mexican based companies establish a partnership with a Mexican entity to conduct clinical trials and obtain product approval in Mexico. SBI said it has identified a potential Mexican partner to obtain approval and distribute Oxycyte for use in cardiopulmonary bypass surgery in Mexico.

“IMMS is . . . a leader in that country's medical research and the largest national institution for training and educating physicians,” said Robert Nicora, president and CEO of SBI. “This clinical trial will be the first Oxycyte study in cardiopulmonary bypass surgery patients.”

SBI said a first-generation PFC blood substitute manufactured in Russia, Perftoran, is currently approved for use in Mexico, but the company believes that its third-generation PFC Oxycyte offers significant advantages over Perftoran, including superior safety, oxygen delivery and efficacy.

The Oxycyte trial in cardiopulmonary bypass surgical procedures is expected to be conducted at two large hospitals in Mexico City. Clinical endpoints for this trial will include safety, oxygen delivery, maintenance of good hemodynamics and avoidance of packed red cell administration.

“Obtaining market approval in Mexico could open significant commercial opportunities for Oxycyte in the future,” Nicora said. “Approval in Mexico could also serve as the basis for Oxycyte registration in other Central and South American countries without the need for additional clinical trials.”

Development accord with Chinese firm

Paradigm Medical Industries (Salt Lake City), a producer of ultrasound devices for the ophthalmic and medical industries, said it has signed a definitive agreement with MEDA (Tianjin, China) to jointly engineer and develop Paradigm's next generation of ultrasound and other medical products.

MEDA is one of China's leading developers and producers of ultrasound devices.

“We are pleased to be working with MEDA. Their engineering, research, and production capabilities are among the best in the world,” said Paradigm Medical President and CEO Raymond Cannefax.

He said, “Initial ultrasound products have been received from MEDA and Paradigm has made initial sales of these devices in Europe. We expect all of our distributors worldwide to be carrying these products by mid-2006.”

Cannefax said that after receiving U.S. and European regulatory approval in 2005 for its third-generation Ultrasound BioMicroscope (UBM), the P60, Paradigm “now [is] working with MEDA on the next-generation UBM as well as other new products and enhancement of our current devices.”

He said that Paradigm Medical is presently the only company that manufactures and sells more than one UBM. “Upon completion of this new UBM project, the company will offer four Ultrasound BioMicroscopes for medical and research sciences applications.”

Paradigm Medical expects to be manufacturing its products at both its facility in Salt Lake City and in Tianjin. “We expect to have a series of new, collaborative products on display at the AAO [American Academy of Ophthalmology] convention later this year,” Cannefax said.

NIMS signs distributor

Non-Invasive Monitoring Systems (NIMS; North Bay Village, Florida) has entered into an agreement with General Medica de Imagenes CxA (Gemedica; Santo Domingo, Dominican Republic ) to distribute AT-101 Motion Platform and future home version of the AT-101 throughout the Dominican Republic.

CEO Gary Macleod said, “Gemedica has a substantial and highly effective marketing and sales presence in the medical device distribution sector in the Dominican Republic and Latin America.” It is a full line distributor for numerous U.S. companies.

AT-101 a noninvasive, whole-body, periodic acceleration, therapeutic vibrator. The company also has developed computer-assisted, non-invasive diagnostic monitoring devices and related software designed to detect abnormal respiratory, cardiac and other medical conditions from sensors placed externally on the body's surface.

Those diagnostic devices have been sold to the SensorMedics Division (Yorba Linda, California) of ViaSys (Conshohocken, Pennsylvania) for cash and royalties on sales and to VivoMetrics (Ventura, California) for royalties on sales and an equity position.