Sabbin bayanai kan gagarumin raguwar hawan jini

Medtronic plc a yau ta sanar da bayanan dogon lokaci daga marasa lafiya na 80 na farko a cikin gwajin SPYRAL HTN-ON MED, wanda aka gabatar a yau a Kwalejin Kimiyya na Kwaleji ta Amurka ta 71st Annual Scientific Session (ACC.22) marigayi-watse ya nuna zaman binciken asibiti. An kuma buga bayanan a lokaci guda a cikin The Lancet.

A cikin marasa lafiya na 80 na farko na gwajin SPYRAL HTN-ON MED, bayanan sun nuna cewa marasa lafiya waɗanda aka wajabta magungunan anti-hypertensive kuma ana bi da su tare da tsarin Medtronic Symplicity Spyral ™ Renal Denervation (RDN) System ya ci gaba da nuna ɗorewa, raguwar hauhawar jini a asibiti. ta shekaru uku. A shekaru uku:

• Rage 18.7 mmHg a cikin marasa lafiya na RDN tare da 8.6 mmHg a cikin sham don 24-hour systolic ambulatory blood pressure (ABPM)

• Rage 20.9 mmHg a cikin marasa lafiya na RDN tare da 12.5 mmHg a cikin hannun sham don hawan jini na ofishin systolic (OSBP)

"A cikin sabbin gwaje-gwajen da aka yi, an sami daidaiton raguwar hauhawar jini a cikin marasa lafiya tare da hauhawar jini mara ƙarfi da aka bi da su tare da tsarin Medtronic Symplicity Spyral RDN," in ji Felix Mahfoud, MD, likitan zuciya a Asibitin Jami'ar Saarland a Homburg, Jamus, kuma memba na SPYRAL HTN. kwamitin zartarwa. "A karon farko, yanzu muna da bayanan da bazuwar da ke nuna cewa a cikin yawan marasa lafiya na yau da kullun - marasa lafiya da ke fama da hauhawar jini waɗanda ke kan magungunan rigakafin hauhawar jini kuma ana bi da su tare da RDN - muna ganin ci gaba da rage tasirin hawan jini na dogon lokaci. Rage cutar hawan jini na iya samun sakamako mai ma'ana na asibiti ga marasa lafiya, gami da raguwar haɗarin abubuwan da ke faruwa a cikin zuciya."

Har ila yau, gwajin ya nuna tsari da aminci na dogon lokaci tare da Symplicity Spyral renal denervation catheter, tare da sifili babban na'ura ko abubuwan tsaro na tsari cikin shekaru uku.

"Tare da bayanan da aka bazu na ON MED da aka gabatar kuma aka buga a yau, Medtronic yanzu ya nuna fa'idar dogon lokaci na renal deneration a kan tushen maganin cutar hawan jini, tare da ci gaba da nuna hanyar aminci," in ji Jeffrey Popma, MD, babban jami'in. Jami'in likitanci na Kasuwancin Coronary & Renal Denervation kasuwanci da Tsarin Zuciya & Kasuwancin Aortic, waɗanda wani ɓangare ne na Fayil na Zuciya a Medtronic. "Wannan yana nuna mahimmancin ƙarin zaɓuɓɓukan jiyya kamar rashin ƙarfi na koda."

An amince da shi don amfani da kasuwanci a cikin ƙasashe sama da 60 a duniya, tsarin hana cutar renal na Symplicity Spyral yana iyakance ga amfani da bincike a cikin Amurka, Japan, da Kanada.

SPYRAL HTN-ON MED gwaji ne na duniya, bazuwar, gwajin sham da ke bincika tasirin rage karfin jini da amincin RDN tare da tsarin Spyral na tushen rediyo na Medtronic Symplicity Spyral a cikin marasa lafiya masu hauhawar jini sun wajabta daya zuwa uku magungunan anti-hypertensive. Bayanan ON MED na dogon lokaci da aka gabatar a ACC.22 sunyi nazari guda ɗaya na marasa lafiya kamar yadda binciken farko na watanni shida wanda aka buga a baya a The Lancet a cikin 2018.

Medtronic ya kammala bazuwar a cikin cikakkiyar ƙungiyar ta SPYRAL HTN-ON MED Trial

Medtronic ya kuma sanar da cewa kwanan nan ya kammala bazuwar ga cikakkiyar ƙungiyar gwajin ta SPYRAL HTN-ON MED da rufaffiyar rajista. Cikakkun ƙungiyar bincike ta yi niyya har zuwa marasa lafiya 340 bazuwar. Medtronic yana tsammanin bin hanyar bayan watanni shida don cikakkiyar ƙungiyar za ta cika a cikin rabin na biyu na shekarar kalanda 2022.

“Bayanan da aka gabatar a ACC sun nuna amincewar Medtronic ga RDN a matsayin mafita ga miliyoyin mutanen da ke fama da cutar hawan jini mara ƙarfi. Wadannan sabbin bayanan za su kasance masu mahimmanci ga jami'an gudanarwa, likitoci da masu biyan kuɗi yayin da muke neman kawo sabon zaɓin magani don kasuwa ga marasa lafiya da hauhawar jini ba tare da kulawa ba, "in ji Jason Weidman, babban mataimakin shugaban kasa kuma shugaban sashin kasuwanci na Coronary & Renal Denervation, wanda wani bangare ne na Fayil na Zuciya a Medtronic. "Muna sa ido a gaba, mun ci gaba da mai da hankali kan bin diddigin watanni shida da ake jira don cikakken rukunin gwaji na ON MED a cikin rabin na biyu na wannan kalandar shekara."

Gwajin SPYRAL HTN-ON MED wani ɓangare ne na Shirin SPYRAL HTN Global Clinical Program, yana ƙarawa ga aminci da ingancin bayanan RDN. Tare da ainihin bayanan duniya daga Registry Symplicity Global, lokacin da aka haɗa tare da ƙwarewar kasuwanci, an sami fiye da hanyoyin 20,000 da aka yi tare da fasahar Medtronic RDN. Shirin na asibiti yana goyan bayan mafi ƙwaƙƙwaran ƙwarewa da ƙwarewar haƙuri da aka yi nazari a gaban da rashin magani da kuma marasa lafiya tare da babban hadarin zuciya na zuciya.